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  • Abbott nabs FDA approval, CE Mark for implantable cardioverter-defibrillator lead
    Abbott has received both FDA and CE Mark approval for its UltiSynq defibrillation lead tech, which is designed to deliver both conduction system pacing and defibrillation therapy.
    Fierce Biotech · 1d agoApprovalPositive↗ source
  • BioNTech spends $205 million on FDA priority review voucher to accelerate oncology pipeline
    BioNTech has agreed to pay $205 million to acquire an FDA priority review voucher, a tool that can shorten the agency's standard review period from ten months to six months. The voucher was previo…
    Fierce Biotech · 1d agoDealPositive↗ source
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  • Flagship-backed Valo Health merges with Montai Therapeutics to boost AI-driven drug pipeline
    Valo Health and Montai Therapeutics announced they will combine under the Valo brand, creating a larger AI-focused biotech aimed at accelerating early-stage drug discovery. Valo, launched in 2020…
    Fierce Biotech · 22h agoDealPositive↗ source
  • Capricor cuts 10% of staff as it readies FDA decision on DMD cell therapy, NextCure trims workforce ahead of merger
    Capricor Therapeutics announced that it has reduced its workforce by about 10% during the third quarter, bringing its employee count down from 231 full‑time staff. The company said it had $198.5 mi…
    Fierce Biotech · 1d agoLayoffsNeutral↗ source
  • Amgen builds Sjögren’s case with detailed phase 3 data ahead of Novartis showdown
    Amgen has shared more data from a phase 3 Sjögren’s disease trial that dazzled analysts, digging into the details that could shape its showdown with Novartis.
    Fierce Biotech · 1d agoDealNeutral↗ source
  • FDA releases draft guidance for early-phase first-in-human studies of solid-tumor therapies
    The U.S. Food and Drug Administration has issued draft guidance to help sponsors design early-phase first-in-human IND studies for investigational drugs and biologics targeting solid tumors. The g…
    raps · 1d agoRegulatoryNeutral↗ source
  • Beam Therapeutics reports year-long reduction in sickle cell crises in phase 1/2 risto-cel study
    Beam Therapeutics disclosed data from its phase 1/2 trial of risto-cel, a base-edited autologous cell therapy targeting the BCL11A gene in sickle cell disease. The trial enrolled 31 adults and ado…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Oura to buy AI virtual care firm Counsel Health for $625 million, expanding in-app health services
    Oura, known for its smart ring and health tracking, announced it will acquire Counsel Health, an AI-driven virtual primary-care provider, for $625 million in cash. The acquisition is slated to clo…
    Fierce Biotech · 1d agoDealPositive↗ source
  • AstraZeneca acquires Omniose to boost bacterial vaccine capabilities
    AstraZeneca has completed the purchase of Omniose, a specialist in vaccine bioconjugation, making the company a wholly owned subsidiary of its infectious disease division. The two firms began coll…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Mirum's hepatitis D antibody brelovitug meets primary endpoint in phase 3 trial
    Mirum Pharmaceuticals announced that its experimental antiviral monoclonal antibody brelovitug achieved the primary efficacy goal in a phase 3 study for hepatitis D. The trial results continue a s…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Start Center for Cancer Research launches Italy’s first early-phase oncology trial site with IFO
    Start Center for Cancer Research has opened its first early-phase cancer clinical trial site in Italy, partnering with the public research hospital group Istituti Fisioterapici Ospitalieri (IFO).…
    Fierce Biotech · 1d agoDealPositive↗ source
  • PepGen's Phase 2 DM1 Data Show 46% Average Splicing Correction, Shares Jump 163%
    PepGen reported results from the 10 mg/kg multiple‑ascending‑dose cohort of its ongoing Phase 2 Freedom2‑DM1 trial, testing PGN‑EDODM1, an oligonucleotide designed to correct the molecular defect i…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Deerfield Management teams with AWS to boost AI-driven life-science ventures
    Deerfield Management announced a collaboration with Amazon Web Services aimed at accelerating AI-native healthcare and life-science companies in its portfolio. The agreement links AWS's generative…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Acting FDA commissioner reports strong public interest in new expedited IND pilot
    Acting FDA Commissioner Kyle Diamantas told attendees at the Friends of Cancer Research annual meeting that the agency’s newly launched Expedited IND pilot has attracted considerable public attenti…
    raps · 2d agoRegulatoryPositive↗ source
  • AbCellera halts development of OX40 antibody ABCL575 after phase-1 trial
    AbCellera announced it will not move ABCL575 beyond phase 1, ending its OX40 program. The phase-1 study met its endpoints, showing a favorable tolerability profile and pharmacokinetics that suppor…
    Fierce Biotech · 2d agoNegative↗ source
  • Coherus Oncology cuts 30% of staff to focus on esophageal cancer combo
    Coherus Oncology announced another round of layoffs, reducing its workforce by about 30% as it narrows its development program. The cuts follow the presentation of phase 1b data on a combination o…
    Fierce Biotech · 2d agoLayoffsNeutral↗ source
  • Novocure's Optune Mya device denied FDA approval over efficacy concerns
    Novocure received a "not approvable" letter from the FDA for its Optune Mya system, which was being evaluated for patients with brain metastases from non‑small cell lung cancer after stereotactic r…
    Fierce Biotech · 2d agoRegulatoryNegative↗ source
  • Laub’s Feeding & Cubing voluntarily recalls 89 tons of mini hay cubes over botulism risk
    Laub’s Feeding & Cubing, Inc. of Beryl, Utah announced a voluntary recall of its Grade A Mini Hay Cubes. The recall covers up to 89 tons of product sold between Oct 3 and Oct 31, 2026 after the co…
    fda recalls · 2d agoCRLNegative↗ source
  • Experts urge pharma firms to build regulatory intelligence before laws take effect
    Regulatory specialists advise companies not to wait for legislation to be finalized before creating a regulatory intelligence framework. They argue that early preparation helps firms stay ahead of…
    raps · 2d agoRegulatoryNeutral↗ source
  • Family Farmstead Dairy recalls all cheddar cheese over possible Listeria contamination
    Family Farmstead Dairy announced a recall of all its cheddar cheese products because they may be contaminated with Listeria monocytogenes. Listeria can cause serious infections, especially in youn…
    fda recalls · 2d agoRegulatoryNegative↗ source
  • Recon: Bayer wins FDA approval for stroke prevention drug; Third Rock enters $2B partnership with AI-focused Chinese biotech
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 2d ago↗ source
  • Delix Therapeutics raises $100M Series C to advance non-hallucinatory psychedelic for depression
    Delix Therapeutics announced a $100 million Series C financing round, led by Johnson & Johnson’s venture arm JJDC and joined by investors such as SV Health Investors’ Dementia Discovery Fund, RA Ca…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Windward Bio targets $204M Nasdaq IPO to fund Chinese respiratory drug program
    Windward Bio, a biotech backed by Sanofi, announced plans to go public on Nasdaq with an offering of 10.3 million shares priced between $16 and $18 each. The company expects net proceeds of about $…
    Fierce Biotech · 2d agoDealNeutral↗ source
  • Argenx acquires Unnatural Products for up to $1.15 billion to boost oral peptide platform
    Argenx announced it will buy biotech Unnatural Products, paying $550 million upfront with the total deal value potentially reaching $1.15 billion through development and regulatory milestones. The…
    Fierce Biotech · 3d agoDealNeutral↗ source
  • India moves to suspend licenses of firms making substandard medicines
    The Indian government has proposed a rule that would immediately suspend the manufacturing licence of any company whose drug fails to meet quality standards. The initiative is intended to boost dr…
    raps · 3d agoRegulatoryNeutral↗ source