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781 stories matching this filter · ← front page

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  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 1mo agoDealPositive↗ source
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fda recalls67
fda medwatch60
fda press38
Psychiatry & CNS858
Ophthalmology491
Pain469
Endocrinology & Metabolism466
Infectious Disease437
  • Novo Nordisk loses bid to dismiss lawsuit over CagriSema trial readout
    U.S. District Judge Robert Kirsch in New Jersey refused to dismiss most of the securities lawsuit filed by investors after Novo Nordisk’s CagriSema readout. While the judge found the plaintiffs’ cl…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Processa Pharma acquires Vidya Therapeutics, gaining oral BTK inhibitor VT-7208
    Processa Pharmaceuticals announced an all‑stock acquisition of Vidya Therapeutics, a Florida biotech developing an oral BTK inhibitor called VT‑7208. VT‑7208 is being positioned as a next‑generati…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Caldera Therapeutics completes reverse merger with Synlogic, secures $278 million financing
    Caldera Therapeutics, a Massachusetts biotech founded last year, announced a reverse merger with Nasdaq-listed Synlogic, giving it a public listing. The transaction includes a $278 million financi…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Nanoparticle-loaded chemotherapy crosses blood-brain barrier in mice after glioblastoma surgery, study shows
    Researchers at the University of Manchester have demonstrated that a standard chemotherapy drug can reach the brain when packaged in liposome nanoparticles and given shortly after tumor removal in…
    Fierce Biotech · 1mo agoPositive↗ source
  • Biogen CEO says company will pause new acquisitions and focus on developing existing pipeline
    Biogen's chief executive Christopher Viehbacher told analysts during the second-quarter earnings call that the company will slow its merger and acquisition activity for the foreseeable future. Aft…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Vertex pays $28 million upfront to AbCellera for autoimmune T-cell engager collaboration
    Vertex Pharmaceuticals has entered a collaboration with AbCellera, paying an upfront sum of $28 million to access the latter’s T-cell engager platform for autoimmune disease programs. Under the ag…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Merck briefly lists, then removes, phase 2 trial of PD-1xVEGF bispecific with TROP2 ADC
    Merck & Co. posted a clinical trial listing for a phase‑2 study combining its PD‑1xVEGF bispecific antibody (MK‑2010) with the TROP2‑directed antibody‑drug conjugate sac‑TMT. The listing, shown as…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Hansoh and GSK's B7-H3 ADC shows progression-free survival benefit in phase 3 osteosarcoma trial in China
    Hansoh Pharmaceutical, in partnership with GSK, announced that its B7‑H3‑directed antibody‑drug conjugate (ADC) met the primary endpoint in a phase 3 study of relapsed osteosarcoma patients in Chin…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Atea’s hepatitis C combo matches Gilead’s Epclusa in phase 3 trial
    Boston-based biotech Atea Pharmaceuticals reported that its once-daily hepatitis C combination of bemnifosbuvir and ruzasvir performed on par with Gilead's Epclusa in a pivotal phase 3 study. The…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Eli Lilly climbs to top of Norstella’s Pipeline-to-Patient Productivity Index, beating 24 peers
    Eli Lilly has risen to the top of Norstella’s inaugural Pipeline-to-Patient Productivity Index, a new benchmark that rates large global biopharma firms on research productivity, market access and c…
    Fierce Biotech · 1mo agoPositive↗ source
  • Claris Bio raises $118M Series B and appoints new CEO to advance eye-drug for limbal stem cell deficiency
    Claris Bio, a New Jersey biotechnology company, announced a $118 million Series B financing round co-led by Samsara BioCapital and Catalio Capital Management, with participation from Sofinnova Inve…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Altimmune’s pemvidutide cuts heavy drinking days in phase 2 AUD trial
    Altimmune announced that its experimental dual GLP-1/glucagon receptor agonist pemvidutide reduced heavy drinking in a phase‑2 study of alcohol use disorder. In the 24‑week Reclaim trial, particip…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Boston Scientific launches multi-year restructuring plan, foresees $500 million annual savings and job cuts
    Boston Scientific announced a global restructuring program that will run from this year through 2029, aiming to streamline its supply chain and reorganize functions. The plan involves moving certa…
    Fierce Biotech · 1mo agoLayoffsNeutral↗ source
  • GSK announces $2.5 billion annual cost-cutting plan to offset upcoming patent cliff
    GSK disclosed in its latest quarterly earnings that it will launch a three-year restructuring aimed at saving about £1.9 billion ($2.5 billion) each year. The plan is intended to cushion the impac…
    BioPharma Dive · 1mo agoLayoffsNeutral↗ source
  • FDA’s AI push faces uncertainty after key leaders depart
    The FDA has been pushing artificial intelligence across the agency, unveiling a large-language-model tool called Elsa to help draft and summarize review reports and announcing plans to use agentic…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • GSK launches three-year £1.9bn savings plan to boost late-stage R&D and relocate research HQ
    GSK announced a three-year cost-saving programme designed to free cash for its late-stage research and development pipeline while moving its research headquarters. The plan targets annual savings…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Incyte drops phase-1 JAK2 inhibitor to focus on next-generation candidates
    Incyte announced it is abandoning its phase-1 JAK2V617F inhibitor, INCB160058, which was being tested in patients with myeloproliferative neoplasms. The decision was disclosed in the company's sec…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Acrosian launches AI-focused biometrics CRO targeting pharma and biotech
    Acrosian has been introduced as a new contract research organization built for the AI era. The firm is founded by Benjamin Jackson, Soumitra Chowdhury and Vladimir Mats, who previously created the…
    Fierce Biotech · 1mo agoPositive↗ source
  • Guardant Health partners with Patrick Dempsey for emotional colorectal cancer screening video
    Guardant Health, maker of the Shield blood test for colorectal cancer, released a new video featuring actor Patrick Dempsey to raise awareness of the disease. In the one‑minute clip, Dempsey watch…
    Fierce Biotech · 1mo agoPositive↗ source
  • Argenx to buy Forte Biosciences for up to $2.2 billion, adding experimental CD122 drug FB102
    Argenx announced it will acquire Forte Biosciences in a transaction valued at up to $2.2 billion. The purchase price is set at $77 per Forte share, roughly a 41% premium to the previous closing pr…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA clears Freenome's SimpleScreen CRC blood test, Abbott to market it in U.S.
    The U.S. Food and Drug Administration has given clearance to Freenome’s SimpleScreen CRC, a blood-based test for colorectal cancer. Abbott will be the exclusive U.S. marketer and will pay Freenome…
    Fierce Biotech · 1mo agoApprovalPositive↗ source
  • Claris Biotherapeutics raises $118M Series B to advance corneal stem-cell eye drop
    Claris Biotherapeutics announced a $118 million Series B financing round led by Novo Holdings and supported by several venture firms. The funding will be used to move its lead candidate, CSB-001, i…
    Fierce Biotech · 1mo agoDealPositive↗ source