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  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 4h agoNegative readoutNegative↗ source
  • ResMed issues correction for Astral ventilators due to electrical component failure risk
    ResMed has released a correction for certain Astral ventilators after identifying a faulty electrical component that could interrupt therapy and cause serious injury or death. The FDA classifies t…
    fda medwatch · 17h agoRegulatoryNegative↗ source
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  • Novo Nordisk's ziltivekimab fails phase 3 trial, jeopardizing CKD program
    Novo Nordisk reported that its phase 3 Zeus trial of the IL‑6 ligand antibody ziltivekimab did not meet its primary endpoint, a setback for the drug's development. The study enrolled more than 6,3…
    Fierce Biotech · 12h agoNegative readoutNegative↗ source
  • Apnimed upsizes IPO to $192 million to fund launch of oral sleep‑apnea drug
    Apnimed, a Massachusetts‑based biotech, announced an upsized initial public offering that now includes 12 million shares priced at $16 each, generating $192 million in gross proceeds. This amount e…
    Fierce Biotech · 16h agoDealPositive↗ source
  • Abiomed recalls 14Fr Low Profile Introducer Kits over thrombus risk
    The FDA has issued an early alert about a recall of Abiomed 14Fr Low Profile Introducer kits, which are used with Impella CP devices. The recall follows a higher‑than‑expected rate of complaints i…
    fda medwatch · 17h agoCRLNegative↗ source
  • Sanofi CEO pledges to rebuild trust and expand partnership with Regeneron
    Sanofi's new chief executive, Belén Garijo, told analysts that restoring the relationship with longtime partner Regeneron is a top priority. She said the company wants to be more transparent and to…
    BioPharma Dive · 5h agoNeutral↗ source
  • Alnylam shares tumble nearly 30% after cutting revenue outlook for key amyloidosis drugs
    Alnylam Pharmaceuticals saw its market value drop about 30%, roughly $12 billion, after it lowered its revenue forecast for its leading amyloidosis treatments. The company had previously expected…
    BioPharma Dive · 1d agoEarningsNegative↗ source
  • Johnson & Johnson secures option to acquire in-vivo CAR-T developer Sail Biomedicines for up to $2.6 billion
    Johnson & Johnson announced a strategic partnership with Sail Biomedicines, a Flagship Pioneering‑backed startup, that includes an upfront cash payment and an equity investment. The initial paymen…
    BioPharma Dive · 1d agoDealPositive↗ source
  • FDA advisory panel backs Replimune's melanoma therapy RP1, raising approval prospects
    Advisors to the U.S. Food and Drug Administration voted 10-3 in favor of Replimune's experimental melanoma treatment, RP1, despite lingering scientific concerns about the data presented. The panel…
    BioPharma Dive · 23h agoRegulatoryPositive↗ source
  • FTC Sues Hims & Hers for Alleged Illegal Sharing of Patient Data and Deceptive Billing
    The Federal Trade Commission has filed a lawsuit against Hims & Hers, a California‑based telehealth company, accusing it of violating privacy laws. The complaint says the firm used tracking pixels…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • Bristol Myers pushes Cobenfy Alzheimer’s psychosis readout to early 2027 after enrollment delays
    Bristol Myers Squibb said the Phase 3 readout for its Cobenfy Alzheimer’s psychosis program will be postponed to early 2027. The company had previously expected data from the three Adept trials to…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • J&J invests $785M in Sail Biomedicines, secures option to buy for $2.58B
    Johnson & Johnson has agreed to pay $785 million up front to Sail Biomedicines, including a $465 million equity infusion and up to $140 million in milestone payments. The agreement also gives J&J a…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Replimune's melanoma virus therapy wins FDA advisory committee vote after two rejections
    Replimune's oncolytic virus RP1, also called vusolimogene oderparepvec and Tudriqev, has been rejected twice by the FDA. Today an advisory committee voted 10 to 3 that the candidate shows enough ef…
    Fierce Biotech · 1d agoRegulatoryPositive↗ source
  • BMS CEO says firm not pressured to pursue acquisitions despite quiet M&A year
    BMS chief executive Chris Boerner told analysts on the second‑quarter earnings call that the company’s robust late‑stage pipeline means it does not feel any compulsion to chase deals. The firm has…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Labcorp reports Q2 sales of $3.73 billion, lifts full-year revenue outlook despite missing consensus
    Labcorp announced second‑quarter revenue of $3.73 billion, up from $3.53 billion a year earlier, driven by strong performance across its core businesses. The Diagnostics division grew 5.5% to $2.9…
    Fierce Biotech · 1d agoEarningsNeutral↗ source
  • Takeda drops its second celiac disease candidate, TAK-101, after unimpressive phase 2 results
    Takeda said it is halting development of TAK-101, its second candidate for celiac disease, after a phase 2 study failed to meet expectations. TAK-101 is a nanoparticle that carries gliadin, a glut…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • GSK signs up to $110 million AI data partnership with Relation
    GSK announced a research collaboration with AI-focused biotech Relation, valued at up to $110 million. Under the agreement Relation will produce large-scale datasets that capture how human cells r…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Sanofi’s new CEO vows deeper review of late-stage pipeline after series of trial failures
    Sanofi appointed Belén Garijo as chief executive in February with a clear mandate to tighten R&D governance and boost productivity. The board tasked her with bringing more rigor to the company’s st…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Argon Medical issues correction for convenience kits containing lidocaine ampules after FDA safety alert
    Argon Medical has sent a correction notice to customers about certain convenience kits that include lidocaine HCl ampules supplied by Spectra Medical Devices. The FDA has classified this correctio…
    fda medwatch · 1d agoCRLNegative↗ source
  • Boston Scientific lowers full-year revenue outlook as restructuring plan targets slowing growth
    Boston Scientific announced on July 29 that it is cutting its 2026 full-year organic revenue growth forecast to 5-6%, down from the prior 6.5-8% range. The revision follows a second consecutive qu…
    Fierce Biotech · 1d agoEarningsNegative↗ source
  • Attovia, Braveheart Bio, and Vogenx aim to raise over $500M through combined IPOs
    Attovia Therapeutics, Braveheart Bio and Vogenx have each filed IPO paperwork, setting price ranges that together target more than $500 million in gross proceeds from public investors. Braveheart…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Legend Biotech CEO Ying Huang resigns abruptly, board taps interim leader
    Legend Biotech announced that its chief executive, Dr. Ying Huang, has stepped down unexpectedly, leaving the role vacant. Huang, who moved from chief financial officer to CEO in 2020 after a cust…
    Fierce Biotech · 1d agoNeutral↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 2d agoEarningsPositive↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 2d agoRegulatoryNegative↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 2d agoRegulatoryNegative↗ source