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1,202 stories matching this filter · ← front page

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  • Gilead and Merck to unveil detailed Phase 3 results of once‑weekly oral HIV regimen at AIDS 2026; Dimension Capital launches $800M fund
    Gilead Sciences and Merck announced that they will present detailed results from their Phase 3 trials of a once‑weekly oral HIV treatment regimen at the upcoming AIDS 2026 conference. The data wil…
    Endpoints · 27d agoNeutral↗ source
  • Novartis says it will keep seeking sub-$2 billion bolt-on deals worldwide, staying geography-agnostic
    Novartis CEO Vas Narasimhan told investors on the second‑quarter earnings call that the company will continue to pursue bolt‑on acquisitions below $2 billion and has no plans to overhaul its busine…
    BioSpace · 27d agoDealNeutral↗ source
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fda recalls41
fda medwatch32
fda press25
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Psychiatry & CNS698
Ophthalmology371
Pain344
Endocrinology & Metabolism343
Infectious Disease334
  • FDA issues warning letter to Alembic Pharmaceuticals over missing patient consent in clinical study
    The U.S. Food and Drug Administration sent a warning letter to Indian generic manufacturer Alembic Pharmaceuticals after it was found to have failed to obtain informed consent from participants in…
    Endpoints · 27d agoRegulatoryNegative↗ source
  • FDA to appoint permanent heads of CBER and CDER alongside new commissioner
    The FDA is preparing to announce a series of senior leadership changes concurrent with the appointment of a new commissioner. Among the planned announcements are permanent appointments for the hea…
    Endpoints · 27d agoRegulatoryNeutral↗ source
  • Agios halts development of next‑generation sickle‑cell drug tebapivat after disappointing mid‑stage trial
    Agios Therapeutics announced it will discontinue development of tebapivat, a next‑generation therapy for sickle cell disease, after the drug failed to demonstrate sufficient efficacy in a Phase 2 t…
    Endpoints · 27d agoNegative readoutNegative↗ source
  • Agios drops next-gen sickle cell drug after Phase 2 data show no advantage over Novo’s candidate
    Agios Pharmaceuticals said it is halting development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a mid‑stage trial failed to demonstrate a benefit ove…
    BioSpace · 27d agoNegative readoutNegative↗ source
  • FDA’s 505(b)(2) pathway offers faster, cheaper drug development and commercial gains
    The FDA’s 505(b)(2) regulatory route lets drug sponsors build on existing safety and efficacy data while proposing meaningful changes to a known product. By leveraging prior findings, companies can…
    BioSpace · 27d agoRegulatoryPositive↗ source
  • Broad Institute partners with Boston Children’s Hospital and Jackson Lab to launch Center for Therapeutic Genetics for rare diseases
    The Broad Institute of MIT and Harvard announced a partnership with Boston Children’s Hospital and the Jackson Laboratory to create a Center for Therapeutic Genetics focused on rare diseases. The…
    Endpoints · 27d agoPositive↗ source
  • Axiom Biosciences targets Hong Kong IPO to raise up to $200 million for regenerative therapy pipeline
    Axiom Biosciences, a San Diego‑based biotech, announced plans to list on the Hong Kong Stock Exchange rather than the traditional U.S. exchanges. The company aims to use the offering to secure new…
    BioSpace · 27d agoDealPositive↗ source
  • Novo Nordisk files lawsuit against Eli Lilly over allegedly deceptive GLP-1 dose ads
    Novo Nordisk has initiated legal action against Eli Lilly in a U.S. court, alleging that Lilly's recent advertisements misrepresent the dosing of GLP-1 obesity treatments. The company says the ads…
    Endpoints · 26d agoNegative↗ source
  • Novartis CEO says China partnerships driven by science, not market strategy
    Novartis chief executive Vas Narasimhan told reporters during the second quarter earnings call that the company’s recent agreements in China are motivated by scientific opportunities rather than a…
    Endpoints · 27d agoDealNeutral↗ source
  • A-Alpha Bio launches AI antibody data consortium with GSK, Boltz and partners
    A-Alpha Bio, a spin‑out founded by David Baker, announced the creation of a new consortium focused on sharing antibody design data. The group aims to address a shortage of high‑quality data that b…
    Endpoints · 27d agoDealPositive↗ source
  • FDA advisory panel to consider reclassifying several widely used peptides
    An FDA advisory committee is meeting this week to decide whether it will recommend reclassifying a group of popular peptide products. The discussion comes as the industry watches closely for any sh…
    Endpoints · 27d agoRegulatoryNeutral↗ source
  • Eli Lilly’s $3.8 B bid for AtaiBeckley signals strong pharma endorsement of psychedelics
    Eli Lilly has announced a proposed acquisition of AtaiBeckley valued at up to $3.8 billion. Analysts at H.C. Wainwright described the move as the clearest strategic validation to date of psychedeli…
    BioSpace · 28d agoDealPositive↗ source
  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 28d agoApprovalPositive↗ source
  • Samsung Biologics to acquire Swiss CDMO PolyPeptide for $1.8 billion, entering peptide API market
    Samsung Biologics announced a plan to purchase Swiss contract development and manufacturing organization PolyPeptide for $1.8 billion in cash. The acquisition will extend Samsung Biologics' manufa…
    Endpoints · 28d agoDealPositive↗ source
  • Vertex’s IgA nephropathy drug povetacicept gains momentum as FDA reviews it after Novartis and Vera approvals
    Vertex Pharmaceuticals’ povetacicept is currently under FDA review with a target action date of Nov. 30 for the treatment of IgA nephropathy. The FDA recently granted full approval to Novartis’ Fa…
    BioSpace · 28d agoRegulatoryPositive↗ source
  • Anthropic ramps up biopharma push with Nobel hires and M&A plans
    Anthropic, known for its artificial‑intelligence models, is expanding its focus to life sciences after a detailed internal memo outlined the move. The memo, released in late 2024, named biology an…
    Endpoints · 28d agoPositive↗ source
  • FDA’s push to publish complete response letters faces legal uncertainty and possible pause
    The FDA began releasing complete response letters (CRLs) to the public last year, a move promoted as increasing transparency for drug developers, investors, and patients. However, the policy has e…
    BioSpace · 28d agoRegulatoryNegative↗ source
  • UK biotech venture capital funding hits record high in Q2 2026, surpassing any full year since 2022
    UK biotech companies secured more venture capital in the second quarter of 2026 than they did in any full calendar year since 2022. The surge reflects a broader fundraising revival, with investors…
    Endpoints · 28d agoDealPositive↗ source
  • Bristol Myers Squibb partners with Nvidia to build pharma's most advanced AI supercomputer
    Bristol Myers Squibb announced it will construct what it calls the most advanced and energy-efficient AI supercomputer system in the biopharma sector. The project will be carried out in partnershi…
    Endpoints · 28d agoDealPositive↗ source
  • Kyverna Therapeutics aims to file first CAR-T cell therapy for autoimmune disease
    Kyverna Therapeutics is preparing what could become the first regulatory filing for a CAR-T cell therapy targeting an autoimmune condition. The company has been developing its miv-cel construct in…
    BioSpace · 28d agoRegulatoryPositive↗ source
  • UnitedHealth outlines AI rollout as quarterly results beat expectations
    UnitedHealth Group, a major health insurer, announced a substantial investment in artificial intelligence earlier this year. The company recently detailed how the technology is being integrated in…
    Endpoints · 28d agoPositive↗ source
  • House lawmakers support US trade panel's probe into China's biotech sector and pricing practices
    At least ten members of the U.S. House of Representatives have voiced support for a trade investigation targeting China’s biotechnology industry. The investigation, led by a U.S. trade panel, will…
    Endpoints · 28d agoRegulatoryNeutral↗ source
  • J&J and AbbVie also considered AtaiBeckley before Lilly’s $2.8 B acquisition
    Johnson & Johnson and AbbVie were reported to have evaluated AtaiBeckley as a potential target in the psychedelic market. The companies did not submit an offer before Eli Lilly closed its $2.8 bil…
    Endpoints · 28d agoDealNeutral↗ source