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21 stories matching this filter · ← front page

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STAT1185Endpoints904BioPharma Dive348BioSpace321Fierce Biotech302onclive165raps107globenewswire health
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allOncology7795Rare Disease1893Cardiology1782Immunology1514Hematology1329Vaccines1208Pulmonology1203
  • 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 · 7h 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 · 6d agoRegulatoryPositive↗ source
73
fda recalls70
fda medwatch60
fda press38
Psychiatry & CNS870
Ophthalmology508
Pain483
Endocrinology & Metabolism483
Infectious Disease450
  • 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 · 6d agoNeutral↗ 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 · 9d agoDealPositive↗ 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 · 15d agoPositive↗ 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 · 20d agoDealPositive↗ 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 · 23d 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 · 24d 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 · 27d 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 · 29d agoPositive readoutPositive↗ 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
  • 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
  • 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
  • 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
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 1mo agoNeutral↗ source
  • OncLive highlights key advances in ovarian, Hodgkin lymphoma, pancreatic, melanoma and myelofibrosis therapies
    The weekly "Five Under 5" roundup from OncLive curates the most notable oncology video content released during the first week of May. It spotlights recent data across a range of cancer types, offer…
    onclive · 4mo agoNeutral↗ source
  • Study Finds Screening Gap for HTLV-1 Linked Leukemia in US Caribbean-Born Communities
    Researchers at Sylvester Comprehensive Cancer Center have highlighted a gap in screening for adult T‑cell leukemia/lymphoma (ATLL) that could be addressed by preventing mother‑to‑child transmission…
    onclive · 4mo agoPositive↗ source
  • Expert Consensus Offers Guidance on Evolving Multiple Myeloma Treatment Strategies
    A 2025 expert consensus presented at the Bridging the Gaps meeting highlighted how quickly multiple myeloma care is changing and gave clinicians practical advice for navigating expanding treatment…
    onclive · 4mo agoNeutral↗ source
  • Fierce Biotech Layoff Tracker 2026: Merck trims more NJ jobs; Novartis nixes Swiss site
    As always, if you know of layoffs occurring at a biotech, please reach out to the Fierce Biotech editorial team.
    Fierce Biotech · 8mo ago↗ source
  • Fierce Biotech Fundraising Tracker '26: Encoded finagles $275M series F; Solstice rises with $225M
    The Fierce Biotech Fundraising Tracker records venture capital rounds of $50 million or more secured by biotechs.
    Fierce Biotech · 8mo ago↗ source