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923 stories matching this filter · ← front page

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  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 2h agoApprovalPositive↗ source
  • Atea's hepatitis C combo therapy shows non-inferior results to Gilead's Epclusa
    Atea Pharmaceuticals announced that its oral combination of bemnifosbuvir and ruzasvir met the predefined non-inferiority criteria when compared with Gilead's Epclusa for treating hepatitis C. The…
    Endpoints · 3h agoPositive readoutPositive↗ source
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  • Kyverna partners with ElevateBio to supply its autologous CAR-T therapy for autoimmune launches
    Kyverna Therapeutics has signed a five‑year manufacturing agreement with contract development and manufacturing organization ElevateBio. The deal makes ElevateBio the primary supplier of Kyverna's…
    BioSpace · 5h agoDealPositive↗ source
  • Incyte drops early-stage JAK2 inhibitor to prioritize next-generation pipeline
    Incyte announced it is terminating development of its early-stage oral JAK2 inhibitor, INCB160058, after a Phase 1 study in myeloproliferative neoplasms. The company said the decision reflects the…
    BioSpace · 5h agoNegative↗ source
  • Leqembi posts $184M Q2 sales, best quarter since launch, Biogen lifts guidance
    Leqembi, the anti-amyloid Alzheimer’s drug co-developed by Eisai and Biogen, generated $184 million in global sales in the second quarter, according to Biogen. The Q2 figure represents the stronge…
    Endpoints · 8h agoEarningsPositive↗ source
  • Biotech earnings season kicks off as Agios reports Phase 2 setback for sickle-cell drug
    The second‑quarter earnings window has begun, and analysts are zeroing in on a handful of biotech companies with high‑profile catalysts. Smaller biotechs are increasingly opting to launch their pr…
    BioSpace · 13h agoNegative readoutNeutral↗ source
  • Teva says it has time to prepare for upcoming US tariffs on imported generic drugs
    Teva CEO Richard Francis said the company believes it has sufficient time to prepare for the tariffs the Trump administration is considering on generic drugs imported from outside the United States…
    Endpoints · 1h agoRegulatoryNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 7h agoNeutral↗ source
  • AI startup Doctronic acquires text-message pediatric care provider Summer Health
    Doctronic, a startup that markets itself as an AI doctor, announced it has purchased Summer Health, a company that offers pediatric care via text messaging. The acquisition expands Doctronic’s ser…
    Endpoints · 6h agoDealNeutral↗ source
  • Former Recursion CEO Chris Gibson joins Dimension Capital as operating partner
    Chris Gibson, who led Recursion Pharmaceuticals for a decade, has taken a new role at venture firm Dimension Capital. At Dimension, he will serve as an operating partner, bringing his experience a…
    Endpoints · 7h agoPositive↗ source
  • NYU's Neil Vasan steps down as acting chair of FDA's oncology drug advisory committee
    Neil Vasan, a professor at NYU, has announced he is stepping down from his role as acting chair of the FDA’s Oncologic Drugs Advisory Committee (ODAC). Vasan has participated in 22 ODAC meetings a…
    Endpoints · 1h agoRegulatoryNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 6h agoLayoffsNegative↗ source
  • Biogen shifts M&A strategy as Apellis acquisition pushes revenue above analyst expectations
    Biogen officially began reporting revenue from the $5.6 billion acquisition of Apellis in the second quarter, shaking up analysts’ consensus estimates and leading to a beat.
    BioSpace · 3h ago↗ source
  • Two biotechs sign reverse mergers to advance I&I drug, BTK inhibitor
    A biotech with a bispecific antibody from China and a little-known San Diego startup with a BTK inhibitor from Gossamer Bio have each signed reverse mergers to take their experimental medicines ont…
    Endpoints · 3h ago↗ source
  • Do you need oncology experience to land an oncology job?
    Business stage is just one factor in whether biopharmas want job candidates to have oncology experience for oncology roles. Two recruiters explain when oncology expertise matters most, the mistakes…
    BioSpace · 5h ago↗ source
  • 7 companies hiring in New York now
    Looking for a biopharma job in New York? Check out the BioSpace list of seven companies hiring life sciences professionals like you.
    BioSpace · 5h ago↗ source
  • Novo ordered to face CagriSema fraud claims from shareholders: New Jersey court
    Shareholders allege that Novo Nordisk withheld information about crucial protocol changes in a Phase 3 study of the weight loss drug CagriSema, which led investors to buy company shares “at artific…
    BioSpace · 6h ago↗ source
  • Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more
    The FDA published briefing documents ahead of advisory committee meetings for therapies from Capricor Therapeutics and Replimune indicate an uphill battle for the biotechs; GSK and AstraZeneca outl…
    BioSpace · 7h ago↗ source
  • FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm
    The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s Duchenne muscular dystrophy cell therapy.
    BioSpace · 1d agoApprovalPositive↗ source
  • GSK shares rise as $2.5B cost-cutting plan unveiled
    As GSK records $2.4 billion in impairment charges for the second quarter, the U.K. pharma has announced a sweeping restructure designed to save about the same amount of money over the next few years.
    BioSpace · 1d agoLayoffsNegative↗ source
  • As pharma descends on China for deals, BIOSECURE Act raises intellectual property risk
    When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
    BioSpace · 1d agoDealNeutral↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 1d agoRegulatoryNeutral↗ source
  • Webinar: Building the Intelligence Engine for Drug Discovery R&D Teams
    Drug discovery teams have more data than ever, but turning that data into actionable insight remains a major challenge. In this candid conversation, Patsnap’s Ben Coverdale is joined by Mark Davies…
    BioSpace · 21h agoRegulatoryNeutral↗ source
  • FDA reminds investors about the risks of advisory panels
    Two days, two similar briefing documents and two companies with diving share prices. The FDA this week laid out its concerns with clinical data from both Capricor Therapeutics and
    Endpoints · 23h agoRegulatoryNeutral↗ source