FDA clears first-of-its-kind Duchenne drug for broad use
Dive Brief: The Food and Drug Administration on Thursday approved a first-of-its-kind drug for Duchenne muscular dystrophy, clearing Duvyzat, a
October 9, 2026
Dive Brief: The Food and Drug Administration on Thursday approved a first-of-its-kind drug for Duchenne muscular dystrophy, clearing Duvyzat, a
Cancer immunotherapy developer NextCure is laying off 37% of its staff and streamlining its research plans, the company said Thursday.
An autoimmune disease drug from Roche and Chugai Pharmaceutical hit its main goal in a closely watched trial, but the
Dive Brief: Orchard Therapeutics said Wednesday it will offer a new gene therapy to children with a rare, devastating disease
A young biotechnology company plans to move an experimental medicine for a rare eye disease into late-stage testing after results
Dive Brief: Orchard Therapeutics on Monday won Food and Drug Administration approval for the first gene therapy to treat a
Dive Brief: Bayer on Tuesday said it plans to seek regulatory approval of a drug for symptoms of menopause following
Ask a healthcare professional (HCP), and chances are good that they’d like an easy way to reach out to biopharma
Gene therapy developer Bluebird bio has raised a large debt financing in a bid to extend its cash runway for
Dive Brief: Tubulis, a German biotechnology startup developing antibody-drug conjugates, brought in €128 million, or about $140 million, to bring
Asgard Therapeutics has become the latest emerging developer of “in vivo” cell therapies to attract the attention of large drugmakers.
Dive Brief: AstraZeneca is bolstering its rare disease division with the purchase of Amolyt Pharma, an endocrine disease specialist backed
The first drug for metabolic dysfunction-associated steatohepatitis will cost $47,400 per year, its developer, Madrigal Pharmaceuticals, said Thursday. Madrigal revealed
Advisers to the Food and Drug Administration have endorsed the use of two cellular medicines for multiple myeloma earlier in
Dive Brief: For the first time, the Food and Drug Administration has approved a cell therapy for hard-to-treat forms of
The Food and Drug Administration has approved the first medicine for a common liver disease that’s been a top target
Dive Brief: The Biotechnology Innovation Organization on Wednesday backed legislation aiming to limit the industry’s association with Chinese life sciences
Dive Brief: Merck on Wednesday announced plans to start clinical trials testing a newer version of its vaccine for human
Two cellular medicines for multiple myeloma were associated with an increased risk of early death in clinical testing, raising questions
For Rick Bedlack, director of the ALS clinic at Duke University, tough times come with the job. He and his
Allogene Therapeutics is turning to gene editing startup Arbor Biotechnologies for help developing “off-the-shelf” cell therapies for autoimmune diseases, the
Dive Brief: Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of
In 2020, a small clinical trial had a big impact. The study evaluated whether a drug from a young and
Boundless Bio, an oncology startup backed by Bayer and Arch Venture Partners, on Wednesday became the first biotechnology company to
Dive Brief: An experimental pill developed by Novo Nordisk helped obese people lose 13% of their body weight after three
A large clinical trial meant to confirm the benefits of a new ALS medication has instead failed, dealing a major
Dive Brief: The Food and Drug Administration is delaying an approval decision on Eli Lilly’s experimental medicine for Alzheimer’s disease
The Food and Drug Administration has expanded the label for Novo Nordisk’s fast-selling weight loss drug Wegovy following study results
Cigna is moving to limit how much health insurance providers and employers have to pay for pricey and in-demand obesity
A Boston-based biotechnology company on Thursday said its most advanced drug showed positive effects in a clinical trial of Parkinson’s
Dive Brief: President Biden is taking on a bipartisan bogeyman ahead of a critical State of the Union speech, targeting
Dive Brief: Barcelona-based venture capital firm Invivo Partners is preparing to close an expected fund of 100 million euros, or
Dive Brief: Sionna Therapeutics, a Waltham, Massachusetts biotechnology startup, announced Wednesday it raised a $182 million Series C round to
Dive Brief: An experimental RNA-based medicine developed by Alnylam Pharmaceuticals, when added to standard drugs, helped lower blood pressure significantly
Dive Brief: Apogee Therapeutics plans to start a Phase 2 study of an experimental eczema treatment in the first half
Investors have poured $62 million into a biotechnology startup developing a drug to treat chronic cough. Nocion Therapeutics, headquartered in
Dive Brief: The effects of an experimental medicine for a common liver disease strengthened with time in a clinical trial,
Dive Brief: Abingworth, a venture capital group owned by Carlyle, will invest as much as $210 million to help Gilead
A good track record can be valuable in the uncertain and risky world of drug development. For a group of
Advisers to the Centers for Disease Control and Prevention are weighing updates to their recommendation older adults get vaccinated for
Dive Brief: Cancer drug developer FogPharma has raised $145 million in fresh funding, the company revealed Friday, announcing a Series
Pfizer believes the answer to its sliding valuation lies in oncology. The company, which is coming off one of the
Gritstone Bio will lay off about 40% of its workforce after missing out on funding it expected to receive this
Kenai Therapeutics, a San Diego-based biotechnology company, has raised $82 million to support its work developing cell therapies for nervous
Dive Brief: ObsEva, a women’s health drug developer, on Wednesday said it plans to wind down its business and let
An Australian-based biotechnology company says a mid-stage clinical trial has shown that psilocybin, a psychedelic compound found in many mushroom
Ginkgo Bioworks has acquired a biotechnology startup co-founded by gene editing pioneer Feng Zhang, part of the cell engineering company’s
Dive Brief: An experimental weight loss drug developed by Viking Therapeutics helped overweight and obese people lose up to 15%
Dive Brief: GSK said Monday that its oral antibiotic succeeded in a late-stage trial in gonorrhea, proving to be as effective
Dive Brief: The Food and Drug Administration on Saturday approved Alvotech and Teva Pharmaceuticals’ Simlandi, a biosimilar of the most
The creativity and expertise of the researchers, technicians and assistants working in healthcare and biopharmaceutical laboratories are critical for every
ORI Capital, the China- and U.S.-based venture investor behind the biotechnology sector’s largest initial public offering this year, has raised
Dive Brief: Novavax will pay as much as $475 million to settle a dispute with Gavi, the Vaccine Alliance over
Dive Brief: Moderna shares rose by as much as 10% Thursday morning after the COVID-19 vaccine developer reported fourth quarter
Dive Brief: BioMarin Pharmaceutical is struggling to sell the first marketed gene therapy for the most common form of hemophilia,
Dive Brief: The European Medicine Agency’s main drug review committee on Friday supported expanding the approval of Johnson & Johnson
The Biden Administration, through the Advanced Research Projects Agency for Health, has committed to invest $100 million into women’s health
Biotechnology startup Frontier Medicines has pulled in $80 million in new funding to support a targeted cancer drug the company
Infectious disease drug developer Vir Biotechnology on Tuesday disclosed that chief medical officer Phil Pang is stepping down from his
A new research paper offers the most thorough look yet at a study that sparked the drug industry’s recent experimentation
Dive Brief: AstraZeneca’s targeted cancer therapy Tagrisso can now be used alongside chemotherapy to treat a common type of locally
Dive Brief: Shares of Rapt Therapeutics fell sharply Tuesday after the company disclosed U.S. regulators ordered a halt of two
Lisa Benincosa is senior vice president of clinical pharmacology strategy at the specialized Clinical Research Organization (CRO), Allucent. Here she
Ce trebuie să știți Colagenul este una dintre cele mai abundente proteine din organism. Ajută la menținerea sănătății pielii, articulațiilor,
Dive Brief: Firefly Bio, a startup working to develop a new kind of cancer medicine, announced Thursday it had raised
Dive Brief: Aurinia Pharmaceuticals will restructure its operations and give money back to shareholders after failing to find a buyer
Astellas Pharma is delving deeper into cell therapies for cancer, announcing Thursday a research deal to develop a pair of
Gilead Sciences is evaluating the future of a cancer drug acquired in a multibillion-dollar deal following a new setback the
Dive Brief: The Food and Drug Administration will decide by June 21 whether to loosen the restrictions surrounding use of
Dive Brief: An experimental drug being developed by Denali Therapeutics and partner Sanofi for ALS failed to meet its goal
Intellia Therapeutics will work with a private biotechnology company to develop genetic medicines for cystic fibrosis, with an initial focus
Dive Brief: Alnylam Pharmaceuticals is delaying the readout of a closely watched Phase 3 trial in the heart disease transthyretin
Dive Brief: The Food and Drug Administration has approved a new regimen for pancreatic cancer, clearing Ipsen’s Onivyde to be
Sage Therapeutics said its new medicine, the first oral treatment for postpartum depression, is off to an encouraging start, with
A little over four years ago, biotechnology giant Amgen retreated from neuroscience research, halting much of its work developing treatments
Dive Brief: Biotechnology startup BioAge Labs has raised $170 million to support an experimental pill it plans to test alongside
Dive Brief: An experimental pill developed by KalVista Pharmaceuticals succeeded in a Phase 3 trial, giving the drug a chance
Six biotechnology startups are merging into a new skin drug developer called Alys Pharmaceuticals, which launched on Monday with $100
As life sciences and pharma services companies forge ahead in 2024, they find themselves at a critical juncture―realizing unparalleled opportunities
Amgen is a global pharmaceutical company worth more than $160 billion. Nine of its marketed medicines are blockbuster products by
BioNTech will pay $50 million and make a $200 million investment in Autolus Therapeutics as the company most famous for
Dive Brief: Neurona Therapeutics, a San Francisco-based biotechnology company, has raised another $120 million to fuel its research into cell
Biotechnology initial public offerings are showing sustained signs of life for the first time in two years, and Kyverna Therapeutics’
Takeda Pharmaceutical plans to quickly begin late-stage testing of an experimental drug for narcolepsy, which, if successful, could help the
Dive Brief: Metagenomi, a gene editing startup spun out of research at the University of California, Berkeley, brought in about
The CEOs of three major drugmakers defended the prices they charge U.S. patients in a Senate committee hearing Thursday, claiming
Dive Brief: Kyverna Therapeutics raised $319 million in a larger-than-expected initial public offering Thursday, adding to an early, but notable,
Dive Brief: BridgeBio Pharma is selling partial rights to an experimental drug for a common form of dwarfism to Japanese
Dive Brief: Scion Life Sciences on Wednesday made its debut as a venture firm, announcing the close of a $310
Sales of Eli Lilly’s diabetes drug Mounjaro exceeded $5 billion in 2023, its first full year on the market, the
To hear venture capitalist Alex Morgan tell it, investors shouldn’t be in the business of predicting trends. “There’s often a
Novo Holdings, the controlling shareholder of Danish drugmaker Novo Nordisk, will buy contract manufacturer Catalent for $16.5 billion in a
In 2021, the Food and Drug Administration for the first time approved a medicine meant to slow the progression of
Dive Brief: The gene therapy company Avrobio agreed to a reverse merger with startup Tectonic Therapeutic after years of struggling
Roche is reshaping its early-stage pipeline of experimental drugs, jettisoning eight drug candidates in neurological conditions and oncology as it
Dive Brief: Protagonist Therapeutics, a biotechnology company focused on peptide drugs, is teaming up with Takeda Pharmaceutical on an experimental,
Another biotechnology company has hit Wall Street via an initial public offering, the third to do so this year in
Arch Venture Partners, one of the biotechnology sector’s most prolific company creators, is raising a new $3 billion fund, according
Merck & Co. plans to continue seeking out multibillion-dollar biotechnology deals to supplement its own drug research as it prepares
Nestlé veteran François-Xavier Roger will succeed Sanofi chief financial officer Jean-Baptiste Chasseloup de Chatillon on April 1, the French pharmaceutical
The U.S. government will test whether centrally coordinating insurance coverage can help people with sickle cell disease access expensive new
GSK on Wednesday reported higher-than-expected sales of its RSV vaccine Arexvy, providing further evidence of the product’s strong uptake. The
Dive Brief: Biotechnology startup Cour Pharmaceuticals has raised $105 million to advance a portfolio of medicines for autoimmune diseases. The
Dive Brief: Gilead has bought a bigger stake in cancer drug developer Arcus Biosciences, announcing Monday it will spend $320
The clue came, as they often do, from an unexpected source. Some sixteen months ago, a small study of five
Dive Brief: An experimental, under-the-skin shot of Bristol Myers Squibb’s immunotherapy Opdivo appeared to work similarly to the approved, intravenous
Johnson & Johnson CEO Joaquin Duato sold 2023 as a “remarkable year” on an earnings call with investors Tuesday. But
Dive Brief: Novo Nordisk is adding yet another prospect to its obesity drug pipeline, this time from a biotech company
After a rocky year that featured a restructuring, job cuts and the resignation of its CFO, BenevolentAI is looking to
Radiopharmaceutical drugmaker RayzeBio drew interest from two other large drugmakers before agreeing to a $4.1 billion buyout by Bristol Myers
European authorities are set to rescind the approval of a Duchenne muscular dystrophy drug that’s been on the market there
Dive Brief: Bristol Myers Squibb’s cell therapy for multiple myeloma, Abecma, should be approved for use in patients whose disease
Dive Brief: ArriVent Biopharma is the second biotechnology company to go public this year, raising $175 million in an initial
The Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for
Cancer drug developer CG Oncology has raised $380 million in an initial public offering than was larger than it expected, a
An 11-year-old boy who was born deaf can hear after receiving an experimental gene therapy, developer Eli Lilly reported on
Sanofi on Tuesday said it will acquire San Diego biotechnology company Inhibrx in a complex deal that could be worth
Dive Brief: The makers of CAR-T cell therapies will need to warn about the risk of new blood cancer, the
Dive Brief: Coherus Biosciences on Monday said it has agreed to sell its approved biosimilar Cimerli, along with supporting staff,
Dive Brief: Gilead Sciences on Monday said its cancer drug Trodelvy missed the main goal of a Phase 3 trial
As part of a makeover promised last year, Bayer is beginning a process of staff reductions that aims to slice
BridgeBio Pharma has agreed to sell future royalties on an experimental rare disease drug in exchange for $500 million if
Five years ago this month, Takeda Pharmaceuticals completed a $62 billion acquisition of Shire — one of the largest deals
Biotechnology company Ikena Oncology on Thursday said it would lay off staff and reallocate resources toward two experimental cancer drugs.
A Congressional committee may subpoena the CEOs of Johnson & Johnson and Merck & Co. to testify about the differences
A radiopharmaceutical drug from Novartis kept a rare type of neuroendocrine cancer at bay for longer than did standard therapy,
Jaguar Gene Therapy is spinning out part of its business to handle the specialized work of manufacturing cell and gene
Mirae Asset Capital Life Science, a new venture capital fund, launched on Thursday, joining several other new firms that have
Dive Brief: Kyverna Therapeutics on Tuesday revealed plans to go public, testing the waters in a biotechnology market that hasn’t
Dive Brief: Massachusetts-based startup Comanche BioPharma has raised $75 million in new venture funding to advance an experimental treatment targeting
The Food and Drug Administration on Tuesday approved Vertex Pharmaceuticals’ CRISPR-based medicine Casgevy for the inherited blood condition beta thalassemia, expanding
Guarded optimism seems to be the mood of the biopharmaceutical industry to start 2024. Last year brought a stock market
Over the span of five months, biotechnology startup Aiolos Bio launched, raised initial funding from venture investors and negotiated a
The J.P. Morgan Healthcare Conference, a yearly temperature taker for the biotechnology industry, had a different feel in 2024. For
Dive Brief: The use of GLP-1-based drugs to treat obesity and diabetes has no “clear relationship” with the risk of
Chris Gibson, the CEO of Recursion Pharmaceuticals, thinks the future of drug discovery lies within a ChatGPT-like interface. At a
A group of high-profile scientists and billionaire financiers are building a new biomedical research institute that they claim will offer
European regulators will seek outside advice before making a decision on approval of Eisai and Biogen’s Leqembi medicine for Alzheimer’s
Dive Brief: The number and amount of biotechnology financings dipped in 2023, with venture firms investing 25% fewer dollars in
The mood shifts on the third day of the J.P. Morgan Healthcare Conference. Deals have been announced and news peters
The arrival of powerful new drugs for obesity has reshaped the pharmaceutical industry, transforming Eli Lilly and Novo Nordisk into
Biotechnology’s embrace of artificial intelligence was never more literal than Tuesday at the J.P. Morgan Healthcare Conference, when AI drug
For the first time, the Food and Drug Administration has authorized a U.S. state to import prescription drugs from Canada,
A California-based company has raised tens of millions of dollars to support its mission of bringing an ecstasy-based therapy to
CRISPR specialist Intellia Therapeutics on Thursday said it will lay off about 15% of its workforce as it pauses some
Dive Brief: Allogene Therapeutics, a leading developer of “off-the-shelf” cell therapies for cancer, will deprioritize two of its most advanced
Dive Brief: Goldman Sachs Asset Management has wrapped up fundraising for the first fund in its Life Sciences investment venture,
Dive Brief: Canada’s health regulators have approved Pfizer’s gene therapy for hemophilia B, the company said Wednesday, making it the
The Food and Drug Administration closed out 2023 with rejections of three drugmaker applications for first approval or expanded use,
Dive Brief: Swiss pharmaceutical company Novartis has formed a new collaboration with partner Voyager Therapeutics, agreeing Tuesday to license one
Merit Cudkowicz has spent her career treating some of the most unforgiving illnesses. She’s watched Alzheimer’s disease steal memories and
Dive Brief: Sanofi will stop developing one of its top cancer drug prospects after the experimental treatment fell short in
Dive Brief: Gene therapy developer MeiraGTx is selling its remaining financial interest in an eye-disease treatment partnered with Johnson &
Dive Brief: The Food and Drug Administration on Thursday approved a new medicine for a form of the rare disease
Bristol Myers Squibb has agreed to acquire Karuna Therapeutics for $14 billion, betting that the biotechnology company’s experimental schizophrenia drug
Sarepta Therapeutics has asked the Food and Drug Administration to expand approval of its gene therapy for Duchenne muscular dystrophy,
Dive Brief: Clene Nanomedicine on Thursday said the Food and Drug Administration doesn’t believe the company has gathered enough evidence
Dive Brief: Weeks after installing a new CEO, BioMarin Pharmaceutical is overhauling oversight of the company at the board level.
Dive Brief: Argenx lost a quarter of its value Wednesday after reporting the second research setback in two months for
Dive Brief: GSK is deepening its investment in cancer treatments called antibody-drug conjugates, announcing Wednesday plans to pay $185 million
Dive Brief: Shares of UniQure dipped more than 10% Tuesday morning after the biotechnology company released more data from a
Dive Brief: DNA sequencing company Illumina said Sunday it will divest Grail, the liquid biopsy maker it fought to hang
Dive Brief: The Novo Nordisk Foundation, which owns a controlling stake in drugmaker Novo Nordisk, said Monday it will invest
An experimental obesity pill being developed by Structure Therapeutics helped lower the blood sugar levels of people with Type 2
European drug reviewers appear likely to recommend against clearing a new medicine from Apellis Pharmaceuticals in another stumble for a
Dive Brief: Days after winning U.S. approval of the first CRISPR gene-editing medicine, Vertex Pharmaceuticals is clearing up potential intellectual
Dive Brief: An experimental cancer vaccine from Moderna and Merck & Co. continued to show promise in treating melanoma, with
The committee that recommends whether drugs should be approved in Europe has thrown its support behind the first medicine based
Dive Brief: The Food and Drug Administration on Thursday broadened use of a drug Merck & Co. acquired in a
Amgen has a new top scientist, announcing Thursday the appointment of Novartis veteran and prolific biotechnology startup founder Jay Bradner
Dive Brief: Vir Biotechnology on Thursday announced a restructuring that will result in a 12% reduction in its workforce as
Pfizer on Wednesday upped the target for its cost-cutting program, revealing the additional spending cuts alongside a sales forecast for
The U.S. Supreme Court announced Wednesday it will review a lower-court ruling that would restrict access to the widely used
Dive Brief: AstraZeneca on Tuesday reached a deal to acquire vaccine developer Icosavax in a deal worth up to $1.1 billion.
Dive Brief: Sanofi terminated a licensing deal with biotechnology company Maze Therapeutics Monday after the Federal Trade Commission filed a
Dive Brief: Biotechnology startup Tome Biosciences emerged from stealth on Tuesday with $213 million in venture funding to develop a
SAN DIEGO — At the American Society of Hematology’s annual meeting, pharmaceutical branding is inescapable. Johnson & Johnson’s and GSK’s
The life sciences industry is evolving rapidly in response to macroeconomic shifts, regulatory changes, cost pressures, large data volumes and
The last line of this century’s most important biomedical research paper contained a hint of the scientific revolution to come.
SAN DIEGO —The 65th annual meeting of the American Society of Hematology got a dramatic introduction. On Friday, as researchers
The vast majority of the people who received Bluebird bio’s newly approved sickle cell disease medicine in a clinical trial
Dive Brief: Spyre Therapeutics, a biotechnology spinout working on antibody drugs for diseases of the gut, announced Friday a $180
The first gene therapies for sickle cell disease may treat the inherited blood condition for many years, if not a
Dive Brief: Biotechnology startup Artbio said Thursday it raised $90 million in a Series A financing that highlighted investors’ appetite
The White House on Thursday took steps to pressure pharmaceutical companies to lower the price of drugs developed with federal
Dive Brief: Venture capital activity in biotechnology is undergoing a “recalibration towards pre-pandemic investment norms,” according to a new quarterly
AbbVie is restocking its drug pipeline in a big way, announcing Wednesday an $8.7 billion deal to buy neuroscience-focused Cerevel
Dive Brief: Pfizer and partner Valneva announced Monday that they have finished enrolling participants in a Phase 3 trial evaluating
The Biotech Innovation Organization on Tuesday named Amicus Therapeutics co-founder and longtime leader John Crowley as its new CEO, taking
Shares in EyePoint Pharmaceuticals more than tripled Monday morning after the Massachusetts-based biotechnology company announced summary results from a mid-stage
Dive Brief: The Food and Drug Administration granted conditional approval to Eli Lilly’s oral cancer drug Jaypirca in two types
With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples.
Dive Brief: A contract research organization working for biotechnology company Acelyrin is disputing suggestions that it may be responsible for
AbbVie is expanding its investment in targeted cancer medicines, announcing Thursday a $10.1 billion deal to acquire ImmunoGen, a pioneer
Dive Brief: Concentra Biosciences has made an unsolicited bid to acquire all outstanding shares of LianBio, a biotechnology company focused
Europe’s drug regulator has more questions about the safety and potential risks of a new, widely popular class of medicines.
Dive Brief: Pfizer will not advance a twice-daily dose of an experimental obesity drug into further testing after results from
Flagship Pioneering is looking to raise $3 billion for its eighth venture fund, a sign the high-profile company creator continues