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1,194 stories matching this filter · ← front page

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  • Acadia’s Alzheimer’s psychosis drug misses primary goal but advances on secondary data
    Acadia Pharmaceuticals reported that its investigational drug remlifanserin failed to meet the primary endpoint in the Phase 2 portion of the RADIANT trial for Alzheimer’s disease psychosis. The t…
    BioSpace · 1mo agoNegative readoutNeutral↗ source
  • Merck’s eye-drug matches Lucentis in vision improvement but raises safety concerns
    Merck reported results from its Phase 2b/3 BRUNELLO trial of remigromig, a Wnt-pathway agonist for diabetic macular edema. The drug achieved non-inferior improvement in best-corrected visual acuit…
    BioSpace · 1mo agoNegative readoutNegative↗ source
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globenewswire health73
fda press59
Psychiatry & CNS1197
Ophthalmology1035
Endocrinology & Metabolism774
Pain768
Nephrology758
  • Basecamp Research secures $140 million Series C to accelerate AI-designed drug pipeline
    Basecamp Research announced closing a $140 million Series C financing round to further develop its AI-driven drug discovery platform. The round was led by venture firm S32 and included participati…
    BioSpace · 1mo agoDealPositive↗ source
  • Senators question FDA nominee as agency issues rule to cut animal testing
    The latest FDA briefing highlighted two key developments: a Senate hearing on the agency’s next leader and a new regulation targeting animal testing. During the confirmation hearing, senators pres…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA signals need for GCP compliance to accept foreign clinical trial data for regulatory review
    The U.S. Food and Drug Administration says it will only consider clinical evidence generated outside the United States if the studies were conducted according to good clinical practice standards.…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Series B funded biotechs expand hiring, Tenpoint Therapeutics raises $85M for eye-health pipeline
    Companies that secured series B rounds this year are scaling up their staff, making them attractive targets for biopharma talent. Tenpoint Therapeutics, based in Warren, New Jersey, announced an $…
    BioSpace · 1mo agoDealPositive↗ source
  • AI-driven interviews risk alienating biotech and pharma job seekers, experts warn
    AI interview tools are being introduced by biotech and pharma firms to speed up candidate screening, but they can create negative experiences for applicants. Candidates described frustrations such…
    BioSpace · 1mo agoNegative↗ source
  • EMA leaders say single pivotal trial should not be default, decision must match evidence needed
    EMA chief Emer Cooke and other officials weighed in on the ongoing debate about the number of pivotal trials required for drug approval. They argued that requiring a single pivotal trial as a rigi…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Senators Question FDA Nominee Overton as Agency Issues New Rule to Cut Animal Testing
    Senators on the Senate Health Committee interrogated President Trump's nominee to lead the FDA, Dr. Janet Overton, during her confirmation hearing. Lawmakers focused on her views about the agency's…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Senate grills Trump’s FDA nominee Heidi Overton on agency priorities
    Heidi Overton, President Trump’s nominee to lead the U.S. Food and Drug Administration, appeared before the Senate for a confirmation hearing on September 24, 2026. Senators from both parties aske…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Galil Importing Corp recalls Lior ground cinnamon over elevated lead levels
    Galil Importing Corp of Hauppauge, New York announced a recall of its Lior Cinnamon Ground Seasoning because of potential elevated lead contamination. The product, distributed to retail outlets in…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Deano’s Pasta recalls 20 lbs of ravioli over undeclared lobster allergen
    Deano’s Pasta of Somerville, Massachusetts announced a recall of its Pear and Pecorino Triangoli Ravioli after discovering the product may contain undeclared lobster, a crustacean shellfish allerge…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • US senators grill FDA nominee Overton on ability to ‘stand up’ to Trump
    In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as…
    BioSpace · 1mo ago↗ source
  • Backed by NVIDIA, Basecamp bags $140M to advance AI-designed drugs
    Basecamp Research joins the growing group of AI-forward biotechs that in recent months have brought in notable sums from investors, including Isomorphic Labs and Enveda.
    BioSpace · 1mo ago↗ source
  • Roche and Ionis report Phase 3 success for RNA therapy sefaxersen in IgA nephropathy
    A late‑stage Phase 3 trial of the Roche‑Ionis RNA‑targeted drug sefaxersen met its primary endpoint, showing a statistically significant reduction in proteinuria for patients with primary IgA nephr…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Ionis and Otsuka's RNA therapy Ulefnersen shows functional and survival gains in rare FUS-ALS in Phase 3 trial
    Ionis Pharmaceuticals and Otsuka Pharmaceutical reported that their antisense oligonucleotide drug Ulefnersen improved both functional impairment scores and overall survival in a Phase 3 study of p…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • China’s $522 bn biotech push fuels US competition and partnership opportunities
    Chinese biotech is entering a rapid growth phase, with the government’s new five-year plan targeting about $522 billion in revenue by 2030 and aiming for at least 25% of first-in-class drugs worldw…
    BioSpace · 1mo agoDealPositive↗ source
  • Amgen's Sjögren's drug dazodalibep meets primary endpoint in Phase 3 trial
    Amgen reported that its experimental therapy for Sjögren's disease, dazodalibep, achieved the primary goal in a late‑stage study. The Phase 3 OASIZ 301 trial enrolled roughly 621 patients with mod…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Novartis signs up to $900 million deal with China's BoomRay for preclinical radioligand therapy
    Novartis has licensed a preclinical radioligand therapy from BoomRay Pharmaceuticals, a Suzhou‑based biotech, in a deal that could be worth up to $900 million. The agreement includes an undisclose…
    BioSpace · 1mo agoDealPositive↗ source
  • Novo outlines $23B revenue goal, cuts 4,000 jobs and expands Wegovy manufacturing amid investor skepticism
    Novo held its Capital Markets Day to detail a plan to reach $23 billion in sales by 2035. The company announced another round of layoffs, trimming its workforce by 4,000 people and leaving the head…
    BioSpace · 1mo agoNeutral↗ source
  • Job postings in Pennsylvania’s biopharma sector surge 213% as nine companies ramp up hiring
    Job postings for biopharma roles in Pennsylvania have jumped dramatically, with BioSpace reporting a 213% year‑over‑year increase in August and overall postings tripling compared with the previous…
    BioSpace · 1mo agoPositive↗ source
  • Pharma companies compete for scarce manufacturing talent as reshoring ramps up
    As pharmaceutical firms expand or add U.S. manufacturing sites to bring production back home, they are finding it hard to staff the plants. The industry faces a limited pool of qualified workers,…
    BioSpace · 1mo agoNeutral↗ source
  • AI drug hunter Enveda raises $311M for late-stage obesity, inflammatory disease push
    Tech darling Enveda has raised a total of $845 million in the past six years. The latest funding round is intended to pave the way for an IPO someday.
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Industry groups back FDA’s proposed distributed manufacturing rule, seek clarification on implementation
    Industry trade groups have expressed overall support for the FDA’s draft rule that would allow drugs to be produced using distributed manufacturing models. The proposal aims to modernize the supply…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Immunovant halts lupus program after Phase 2b trial fails to meet efficacy endpoints
    Immunovant announced that its anti‑FcRn drug imeroprubart (IMVT‑1402) did not achieve the primary endpoint in a Phase 2b study in patients with cutaneous lupus erythematosus. The double‑blind tria…
    BioSpace · 1mo agoNegative readoutNegative↗ source