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40 stories matching this filter · ← front page

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STAT1156Endpoints875BioPharma Dive339BioSpace293Fierce Biotech277onclive165raps104globenewswire health
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allOncology7371Rare Disease1827Cardiology1673Immunology1456Hematology1302Vaccines1173Pulmonology
  • 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 · 50m agoLayoffsNegative↗ source
  • ARPA-H allocates up to $125 million to accelerate personalized RNA therapy manufacturing
    ARPA-H announced a new program, called GIVE, that will provide up to $125 million in research funding to develop faster, decentralized manufacturing methods for individualized RNA‑based genetic med…
    BioSpace · 4d agoRegulatoryPositive↗ source
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73
fda recalls67
fda medwatch60
fda press38
1084
Psychiatry & CNS858
Ophthalmology492
Pain470
Endocrinology & Metabolism466
Infectious Disease437
  • Invivyd appoints chairman Marc Elia as CEO ahead of COVID antibody readout
    Invivyd, an infectious-disease biotech, announced that its chairman Marc Elia will also serve as chief executive officer. Elia, who joined the board in 2022 and helped shape the company's scientif…
    Fierce Biotech · 4d agoNeutral↗ source
  • Novartis and Bristol Myers pause autoimmune CAR-T trials after serious safety events
    Novartis and Bristol Myers Squibb announced the suspension of several autoimmune CAR‑T studies after encountering serious safety problems. In Novartis' trials, three participants died from a severe…
    BioPharma Dive · 5d agoNegative readoutNegative↗ source
  • Electra Therapeutics files for Nasdaq IPO to fund phase 2/3 immunology and cancer programs
    Electra Therapeutics, based in South San Francisco, announced it has filed a registration statement to list its shares on the Nasdaq Global Select Market under the ticker ETRA. The company says th…
    Fierce Biotech · 7d agoDealPositive↗ source
  • FDA approves Priovant's Lisraya (brepocitinib) for rare skin disease dermatomyositis
    The U.S. Food and Drug Administration has cleared the first oral targeted treatment for dermatomyositis, a rare and disabling skin disorder. The medication, brepocitinib, will be sold under the br…
    BioPharma Dive · 10d agoApprovalPositive↗ source
  • Labcorp introduces reflex hepatitis D test to improve detection of severe viral hepatitis
    Labcorp has launched a new hepatitis D (HDV) reflex testing option as part of its Comprehensive Hepatitis Testing portfolio, aiming to close a gap in HDV monitoring. The test automatically adds HD…
    Fierce Biotech · 13d agoPositive↗ source
  • Activist Kaos Capital pushes governance overhaul at Capricor ahead of FDA Duchenne decision
    Activist investor Kaos Capital has sent a letter to Capricor Therapeutics shareholders demanding a “governance reset.” The firm asks for a meeting to nominate two independent directors, create an M…
    BioPharma Dive · 17d agoNegative↗ source
  • Eli Lilly partners with Amplitude Therapeutics to develop trans-amplifying RNA vaccines for infectious diseases
    Eli Lilly announced a collaboration with Boston-based Amplitude Therapeutics, a company that emerged from Lilly’s Gateway Labs incubator. The partnership will focus on developing trans-amplifying…
    Fierce Biotech · 18d agoDealPositive↗ source
  • FDA rejects Osteal Therapeutics' combo therapy for joint-implant infections
    The U.S. Food and Drug Administration rejected Osteal Therapeutics' lead combination therapy late last month. The agency cited concerns that prevented approval of the product intended to treat infe…
    Endpoints · 18d agoRegulatoryNegative↗ source
  • FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax
    Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.
    BioPharma Dive · 21d agoApprovalPositive↗ source
  • Regeneron halts Phase 1/2a uveitis trial of anti-CD3 antibody after safety event
    Regeneron announced it is voluntarily ending the Phase 1/2a TITAN study of its anti‑CD3 monoclonal antibody, REGN7041, which was being evaluated for non‑infectious posterior uveitis. The decision…
    Fierce Biotech · 21d agoCRLNegative↗ source
  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 21d agoRegulatoryNeutral↗ source
  • Former Legend Biotech CEO Ying Huang appointed head of K2 Therapeutics
    K2 Therapeutics announced that Ying Huang, who recently left his role as CEO of Legend Biotech, will now lead the young biotech company. The appointment comes just weeks after Legend announced Huan…
    Fierce Biotech · 25d agoNeutral↗ source
  • Combination therapy including leronlimab clears HIV in infant macaques, offering new cure hope
    CytoDyn researchers tested leronlimab together with broadly neutralizing antibodies and antiretroviral therapy in a cohort of 55 infant macaques. Only the eight animals that received the full three…
    Fierce Biotech · 27d agoPositive readoutPositive↗ source
  • Revolution Medicines sees strong demand for pancreatic cancer drug daraxonrasib under compassionate use
    Revolution Medicines reports that more than 2,000 patients have received its pancreatic cancer candidate daraxonrasib through a compassionate use program. The company says the drug has been distri…
    BioPharma Dive · 1mo agoPositive↗ source
  • Roche launches cyclospora PCR tests as lettuce-linked outbreak spreads across 15 US states
    Roche Diagnostics announced the rollout of two new real-time PCR assays that detect the parasite Cyclospora cayetanensis. The launch comes as the CDC and FDA report that the cyclospora outbreak li…
    Fierce Biotech · 1mo agoPositive↗ source
  • FDA approves Moderna's first mRNA flu vaccine for adults 50 and older
    The Food and Drug Administration has granted approval to Moderna's mRNA flu vaccine, called mFlusiva and previously known as mRNA-1010, making it the first preventive flu shot built on messenger RN…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Moderna's mRNA flu vaccine mFLUVISA receives FDA approval after earlier filing refusal
    The U.S. Food and Drug Administration initially issued a refusal-to-file letter to Moderna's flu vaccine in February, but a few days later reversed that decision and accepted a revised submission f…
    BioSpace · 1mo agoApprovalPositive↗ source
  • Vedanta Biosciences secures $60 million to complete Phase 3 trial of C. difficile microbiome therapy
    Vedanta Biosciences, a Cambridge, MA biotech focused on microbiome therapeutics, announced it has raised $60 million in new financing. The capital will be used to advance its lead candidate target…
    Endpoints · 1mo agoDealPositive↗ source
  • Fecal microbiome transplant boosts peanut tolerance sixfold in early trial
    Researchers at Boston Children’s Hospital conducted a small open‑label phase 1 trial in which 15 adult participants received oral encapsulated fecal microbiome transplantation to test safety and ef…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Expedition Therapeutics raises $115M Series B to fund phase 2 COPD trial of DPP1 inhibitor
    Expedition Therapeutics, backed by Sanofi, announced a $115 million Series B financing round. The round was led by General Atlantic with participation from RA Capital, Vivo Capital, and existing i…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Moderna delays norovirus vaccine readout, cites insufficient infections
    Moderna announced that its norovirus vaccine trial will not yield efficacy data this season because infection rates were lower than expected. The company said it will open an additional trial coho…
    Endpoints · 1mo agoNegative readoutNeutral↗ source
  • Merck launches voluntary licensing for investigational monthly HIV PrEP pill ahead of approval
    Merck has signed voluntary licensing agreements to allow generic manufacturers to produce its investigational monthly HIV PrEP pill, alimatravir, before any regulatory submission. The agreements c…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion, adding late-stage depression drug
    Eli Lilly announced it will acquire New York‑based biotech AtaiBeckley in a transaction valued at about $2.8 billion. The agreement sets the purchase price at $6.75 per share, a 26 % premium to At…
    BioPharma Dive · 1mo agoDealPositive↗ source