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336 stories matching this filter · ← front page

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  • Eli Lilly to seek FDA approval for retatrutide in early 2027 after Phase 3 trials show over 20% weight loss
    Eli Lilly said its next‑generation obesity drug retatrutide produced substantial weight loss in two late‑stage Phase 3 studies. The data were presented from the TRIUMPH‑2 and TRIUMPH‑3 trials, whic…
    BioSpace · 29d agoPositive readoutPositive↗ source
  • GSK receives FDA approval for ROS1 inhibitor Jideytro, marking its first lung cancer drug
    GSK's FDA approval of Jideytro, a ROS1 inhibitor for advanced non-small cell lung cancer patients with ROS1 gene fusions who have already received ROS1-directed therapy, was announced on Wednesday.…
    BioSpace · 29d agoApprovalPositive↗ source
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fda recalls47
fda medwatch38
fda press28
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Psychiatry & CNS724
Ophthalmology421
Endocrinology & Metabolism384
Pain376
Infectious Disease357
  • BeOne invests $300 million in New Jersey plant, adding small-molecule capacity and 120 jobs
    BeOne Medicines announced a $300 million investment to expand its manufacturing campus in Hopewell, New Jersey. The expansion will include a three‑story, 145,000‑square‑foot building for small‑mol…
    BioSpace · 29d agoDealPositive↗ source
  • Roche says its late-stage pipeline is full, sees growth through 2030
    Roche's CEO Thomas Schinecker told analysts that the company has 19 investigational medicines that could launch by 2030, indicating a robust late-stage pipeline. He added that the depth of the pip…
    BioSpace · 29d agoEarningsPositive↗ source
  • Biopharma firms must prioritize hiring and retaining commercial talent for successful drug launches
    A BioSpace webinar brought together commercial leaders and a recruiting specialist to discuss how biopharma companies can better hire and keep commercial staff as they prepare for new product launc…
    BioSpace · 29d agoNeutral↗ source
  • Biopharma layoffs must double in second half of 2026 to match 2025 cuts
    The first half of 2026 saw biopharma companies cut slightly fewer jobs than the same period a year earlier, with layoffs affecting about 2% fewer employees overall. To reach the total workforce re…
    BioSpace · 29d agoLayoffsNegative↗ source
  • FDA says it has not paused CRL releases amid transparency push
    An unnamed pharmaceutical company filed a citizen petition in April asking the FDA to change how it publicly releases Complete Response Letters, arguing the new policy conflicts with long‑standing…
    BioSpace · 28d agoRegulatoryNeutral↗ source
  • Nordic biotech must unite to become a global force, say venture investors
    The latest episode of BioSpace's podcast Denatured features Ester Sklarsky of Sound Bioventures and João Ribas of Novo Holdings Seed Investments discussing the future of Nordic biotech. The guests…
    BioSpace · 29d agoNeutral↗ source
  • Midwest Poultry Services recalls over 1.5 million dozen eggs over possible Salmonella Enteritidis contamination
    Midwest Poultry Services, L.P. announced a voluntary recall of 1,589,577 dozen white and brown cage-free shell eggs produced in Texas. The recall was triggered by a potential contamination with Sa…
    fda recalls · 29d agoCRLNegative↗ source
  • Chairman of Urbo Bank purchases €25,000 of bank's subordinated bonds
    Urbo bankas UAB disclosed that its Chairman of the Board, Marius Arlauskas, acquired the bank's subordinated bonds. The acquisition covered 25 bonds with a total consideration of EUR 25,000 and wa…
    globenewswire health · 29d agoRegulatoryNeutral↗ source
  • Alm. Brand A/S discloses executive share transactions per EU regulation
    Alm. Brand A/S has issued a regulatory filing that details recent trading activity in its own shares by company executives and their related parties. The disclosure is made under Article 19 of EU…
    globenewswire health · 29d agoRegulatoryNeutral↗ source
  • Urbo Bank discloses board chair’s purchase of 25 subordinated bonds for €25,000
    Urbo Bank announced that its board chairman and administration head, Marius Arlauskas, bought 25 units of the bank’s subordinated bonds (ISIN LT0000135659). The purchase, amounting to €25,000, was…
    globenewswire health · 29d agoDealNeutral↗ source
  • AstraZeneca’s rare disease drug Wainua fails Phase 3, narrowing path to $80 billion sales goal
    AstraZeneca announced that its rare disease therapy Wainua did not meet its primary endpoints in a Phase 3 trial, ending plans to broaden the drug’s label for transthyretin amyloidosis cardiomyopat…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Repligen to acquire BioLife Solutions for $1.5 billion, boosting its role in cell therapy preservation
    Repligen announced a $1.5 billion acquisition of BioLife Solutions, a company whose CryoStor media is used to preserve cell therapies during storage and transport. BioLife’s products are employed…
    BioSpace · 1mo agoDealPositive↗ source
  • Eli Lilly’s $3.8 billion acquisition of AtaiBeckley signals strong backing for psychedelic therapeutics
    Novartis and Roche kicked off the second‑quarter earnings season, with other majors such as AstraZeneca, GSK and Biogen slated to follow. The earnings wave highlights continued revenue growth acros…
    BioSpace · 1mo agoDealPositive↗ source
  • Arrowhead reports Phase 3 data showing potentially best-in-class triglyceride reduction, eyes FDA filing
    Arrowhead Pharmaceuticals announced topline results from two late-stage Phase 3 trials (SHASTA-3 and SHASTA-4) of its siRNA drug plozasiran in patients with severe hypertriglyceridemia (sHTG). Th…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Congressional panel warns US rare-disease lead is eroding and calls for supportive policies
    A Congressional advisory panel has urged the U.S. government to adopt policies that would help rare disease drug development, including a finalized FDA platform designation and the use of novel tri…
    BioSpace · 1mo agoNegative↗ source
  • AI data emerges as a key hurdle in biopharma partnership deals
    As drug discovery becomes more intricate, the data used to train AI models is turning into a valuable asset in biopharma transactions. Companies are now negotiating not just drug candidates but the…
    BioSpace · 1mo agoDealNegative↗ source
  • Summit and Akeso sharpen case for ivonescimab with new Western data
    Summit Therapeutics and Akeso are answering questions raised about ivonescimab’s ability to translate to Western populations, though the partners have yet to share if the new findings are statistic…
    BioSpace · 29d agoRegulatoryNeutral↗ source
  • Why moving from Big Pharma to a midsize specialty firm can boost impact and leadership
    Thomas Kolaras, formerly with large pharmaceutical companies, now works at SERB Pharmaceuticals and reflects on the benefits and constraints of big‑pharma environments. He highlights the rigorous p…
    BioSpace · 1mo agoPositive↗ source
  • Webinar Highlights Emerging Recovery in Biopharma Hiring and Talent Strategies for Commercial Growth
    The BioSpace webinar "From Clinical to Commercial: Talent Strategies for Biopharma Growth" examined recent hiring activity across the biopharma sector and offered guidance for companies preparing t…
    BioSpace · 29d agoPositive↗ source
  • Cambridge biopharma job postings surge 120% as six firms ramp up hiring
    Job listings for biopharma positions in Cambridge, Massachusetts, have jumped 120% year over year on the BioSpace platform. The upward trend began in February, saw a brief dip in May, and accelerat…
    BioSpace · 1mo agoPositive↗ source
  • Novartis drops mid-stage radioligand therapy 177Lu-NeoB after weak early data
    Novartis has discontinued its mid-stage radioligand therapy 177Lu-NeoB, which was being tested for breast cancer and other solid tumors. The company said early clinical data did not show enough ef…
    BioSpace · 1mo agoNeutral↗ source
  • Dyne Therapeutics receives early 2027 FDA decision date for Duchenne therapy, analysts anticipate smooth review
    Dyne Therapeutics' investigational Duchenne muscular dystrophy therapy, zeleciment rostudirsen, has had its BLA accepted by the FDA with a target action date of Jan 21, 2027. Analysts at Oppenheim…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Samsung Biologics proposes $1.8B acquisition of PolyPeptide to enter fast-growing obesity peptide market
    Samsung Biologics, a South Korean contract development and manufacturing organization, announced an offer to acquire Swiss CDMO PolyPeptide for CHF 1.46 billion (about $1.8 billion). PolyPeptide s…
    BioSpace · 1mo agoDealPositive↗ source