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  • FDA approves first expandable pediatric pulmonary heart valve
    The FDA has cleared a new surgically implanted pulmonary valve designed for children with congenital pulmonary valve disease. The device, called the Autus Size-Adjustable Valve, was developed by E…
    Fierce Biotech · 1mo agoApprovalPositive↗ source
  • Vaxcyte’s 31-valent pneumococcal vaccine shows non-inferior immunity to Pfizer and Merck shots in Phase 3, shares surge
    Vaxcyte’s 31-valent pneumococcal candidate, VAX-31, was compared head‑to‑head with Pfizer’s Prevnar 20 and Merck’s Capvaxive in the late‑stage Opus‑1 study aimed at preventing invasive pneumococcal…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
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  • CSL pays $355M upfront to co-develop Alentis’ phase-2 fibrosis drug lixudebart
    CSL of Australia has agreed to pay $355 million upfront for the rights to Alentis Therapeutics' anti-Claudin-1 drug lixudebart, a phase-2 fibrosis candidate. The agreement includes up to $1.2 bill…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Genmab’s Rina-S ADC shows 9.5-month median PFS, touted as superior to AbbVie’s Elahere
    Genmab reported median progression‑free survival of 9.5 months for its FRα‑directed antibody‑drug conjugate Rina‑S in part C of the phase 1/2 Rainfol‑01 trial, which enrolled 109 patients with plat…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Scientists awarded 2026 Nobel Prize for pioneering optogenetics light-switch technique
    The 2026 Nobel Prize in Physiology or Medicine was awarded to Karl Deisseroth, Peter Hegemann and Georg Nagel for their work on optogenetics, a technique that uses light to control neurons. The me…
    Fierce Biotech · 1mo agoPositive↗ source
  • Genentech pays Alector $100M for preclinical Parkinson’s prospect
    Genentech is paying Alector $100 million upfront for exclusive rights to a preclinical drug candidate that targets a driver of neurodegeneration in Parkinson’s disease.
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • FDA warns Evolus over misleading Instagram claims about Jeuveau
    The FDA's Office of Prescription Drug Promotion sent an untitled warning letter to Evolus, the maker of the injectable cosmetic product Jeuveau. The letter says the company exaggerated the drug’s…
    raps · 1mo agoRegulatoryNegative↗ source
  • Bayer to invest $2.2B in new Ohio manufacturing complex as FDA CDER opens clinical trial modernization office
    Bayer announced plans to spend roughly $2.2 billion on a new manufacturing site in Ohio, aiming to broaden its production capabilities. The investment is projected to increase capacity and generat…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA Requests Public Feedback on Designing Early-Phase Trials for Psychedelic Drug Ibogaine
    The U.S. Food and Drug Administration announced it is seeking comments from the public on how to structure early-phase clinical studies of ibogaine, a plant-derived psychoactive compound. The agen…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Mimetic Medicines' peptide reduces pain-related sodium channels in mice, offering new neuropathic pain strategy
    Researchers at Mimetic Medicines tested a short lipidated peptide (SLiP) in mice and found it lowered the presence of Nav1.8 sodium channels on sensory neuron membranes. Reducing these channels hel…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Australia's TGA begins five-year transition to new medicine labeling standards
    The Therapeutic Goods Administration has adopted two new labeling standards for medicines in Australia. The standards will become mandatory after a five-year transition period that starts now. Ph…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Novartis signs $7.8 billion deal with Abogen for mRNA-encoded autoimmune T-cell engager
    Novartis announced it will pay $575 million upfront to Abogen Biosciences for an mRNA-encoded T-cell engager that has shown early clinical activity in autoimmune disease. The agreement includes up…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Xaira Therapeutics details its generative AI antibody platform X-Design and unveils first pipeline candidates
    Xaira Therapeutics, which raised $1 billion in 2024, has now shared details of its AI-driven antibody design platform called X-Design and provided a glimpse of its emerging pipeline. The company s…
    Fierce Biotech · 1mo agoPositive↗ source
  • Abbott begins U.S. sales of SimpleScreen CRC, an FDA-approved blood test for average-risk colorectal cancer screening
    Abbott has started commercial sales in the United States of SimpleScreen CRC, a blood‑based test cleared by the FDA for colorectal cancer screening in adults 45 years and older who are at average r…
    Fierce Biotech · 1mo agoPositive↗ source
  • FDA device center outlines FY 2027 guidance agenda, focusing on AI devices and change control plans
    The FDA's Center for Devices and Radiological Health announced its guidance priorities for fiscal year 2027 on Oct 1. The top items are finalizing guidance on artificial intelligence‑enabled medic…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Gate CEO sees expanded $870M pact with Lilly as ‘vote of confidence’ in biotech’s platform
    Eli Lilly has been pushing at an open door by tacking on $870 million in biobucks to its existing collaboration with Gate Bioscience.
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • FDA device center outlines FY 2027 guidance plan, targeting AI-enabled devices and change-control plans
    On Oct 1, the FDA’s Center for Devices and Radiological Health announced its guidance agenda for fiscal year 2027. The top priority is finalizing guidance for artificial intelligence-enabled medic…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Stewart’s Shop Corp. Recalls Heavenly Medley and Vanilla-Chocolate-Strawberry Due to Possible Foreign Object
    October 2, 2026, Stewart’s Shops Corp. of Saratoga Springs, NY is recalling two flavors, Heavenly Medley and Vanilla-Chocolate-Strawberry, of half-gallon ice cream due to the potential presence of…
    fda recalls · 1mo agoRegulatoryNeutral↗ source
  • Key criteria for selecting a biologics CDMO: reliability, cost, technology and partnership fit
    Choosing the right contract development and manufacturing organization is a strategic move for biotech and biopharma firms, as it can speed development and lower regulatory risk. The top priority…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Immunotherapy startup Adecto shuts down, citing risk-averse funding climate
    Adecto Pharmaceuticals, a Boston-based immunotherapy biotech founded in 2014 by Tufts researchers, announced it is closing after 12 years. The company had been developing AD100, a monoclonal antib…
    Fierce Biotech · 1mo agoNegative↗ source
  • Flowers Foods recalls Nature’s Own Hawaiian Bread after discovering undeclared milk allergen
    Flowers Foods announced on October 2, 2026 that it is pulling its Nature’s Own Hawaiian Bread from the market. The recall covers both the 20‑ounce loaves and the 40‑ounce two‑pack versions sold und…
    fda recalls · 1mo agoCRLNegative↗ source
  • EAK Distribution recalls Home Grown broccoli seed packets over possible Salmonella contamination
    EAK Distribution LLC announced on October 2, 2026 that it is recalling its 8‑oz Home Grown Green Sprouting Calabrese Broccoli Seeds due to a potential Salmonella contamination. The company warned…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Frutas y Hortalizas del Sur expands recall to more Great Value and Trader Joe's frozen berry products over E. coli risk
    Frutas y Hortalizas del Sur S.A., a Chilean producer, announced on Oct 2, 2026 that it is expanding its earlier recalls of frozen organic berries. The expansion adds additional lots of Great Value…
    fda recalls · 1mo agoCRLNeutral↗ source
  • Sanofi pays Regeneron $1 billion upfront to co-develop four early-stage immunology assets
    Sanofi has agreed to pay Regeneron an upfront fee of $1 billion to partner on four early‑stage immunology programs, a move intended to capture the success of their joint Dupixent antibody. Dupixen…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Roche Diagnostics unveils single-assay newborn test for SMA, SCID and Sickle Cell Disease
    Roche Diagnostics introduced a new in‑vitro diagnostic kit called LightMix Newborn TREC/SMN1/HBB that can screen newborns for three rare genetic disorders in a single test. The assay simultaneousl…
    Fierce Biotech · 1mo agoPositive↗ source