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3,128 stories matching this filter · ← front page

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  • FDA issues revised draft guidance for drug-device combination product performance
    The U.S. Food and Drug Administration has released a revised draft guidance aimed at helping sponsors of drug-device combination products develop essential drug delivery device performance characte…
    raps · 15d agoRegulatoryNeutral↗ source
  • Eli Lilly consolidates US and international sales under new global markets unit as veteran exec retires
    Eli Lilly announced that long‑time executive Patrik Jonsson will retire after 36 years with the company. Jonsson has been serving as executive vice president and president of Lilly International, o…
    Fierce Biotech · 14d agoNeutral↗ source
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  • HHS to allow compounders to make 6 unapproved peptides
    RFK Jr. has given notice that the agency won’t take enforcement action on six peptides that controversially won a contested recommendation from outside advisers to the FDA in July.
    BioPharma Dive · 15d ago↗ source
  • Genmab's bispecific combo with Keytruda halves death risk in phase 3 head‑neck cancer trial
    Genmab announced interim results from its phase 3 LiGeR-HN1 study, showing that adding the bispecific antibody petosemtamab to Merck's Keytruda significantly improved outcomes for patients with PD-…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • Lilly's retatrutide outperforms Ozempic in phase 3 trial, cutting blood sugar and weight more
    Eli Lilly tested its triple-G candidate retatrutide against Novo Nordisk's Ozempic (semaglutide) in an open-label phase 3 study involving about 1,300 adults with type 2 diabetes whose glucose was n…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • Astellas commits up to $285M upfront for Audax's preclinical IL-12 program, with potential $1.05B milestones
    Astellas Pharma has entered a licensing agreement with Audax Biosciences to gain rights to the latter’s IL-12 immuno‑oncology candidate DAX‑044. Under the deal, Astellas will pay up to $285 millio…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Geron halts phase 3 Rytelo trial after data monitoring panel deems unlikely to improve survival in JAK-inhibitor-pretreated myelofibrosis
    Geron announced the discontinuation of its phase 3 IMpactMF trial of Rytelo (imetelstat) in patients with myelofibrosis who had previously failed JAK inhibitor therapy. The decision followed an in…
    Fierce Biotech · 15d agoNegative readoutNegative↗ source
  • FDA outlines pathway for approval of personalized gene-editing therapies
    The U.S. Food and Drug Administration released a set of recommendations describing how developers can pursue regulatory approval for gene-editing treatments that are customized to a single patient’…
    Endpoints · 15d agoRegulatoryNeutral↗ source
  • AstraZeneca’s heart drug Wainua fails late-stage trial, raising 2027 outlook concerns
    AstraZeneca announced that its experimental heart disease therapy, Wainua, did not meet primary endpoints in a Phase III trial conducted in July. The failure is a setback for the company, whose pi…
    Endpoints · 15d agoNegative readoutNegative↗ source
  • Pfizer shuts India cancer drug plant for up to two years, worsening drug shortages
    Pfizer has temporarily closed a manufacturing site in India that produces several cancer medicines. The company says the facility will remain idle for as long as two years while it addresses the i…
    Endpoints · 16d agoRegulatoryNegative↗ source
  • Formation Bio raises $600 million fund to expand AI-driven drug licensing and testing model
    Formation Bio, an AI-focused biotech that builds value by acquiring external drug assets, developing them and then transferring them to partners, announced a new financing round. The company secur…
    Endpoints · 15d agoDealPositive↗ source
  • Oura and UC San Diego Health launch trial linking smart ring data to obesity treatment outcomes
    Oura and UC San Diego Health have partnered on a multi-year clinical trial called SMART-BMI to explore how continuous data from the Oura Ring may reflect patient response to obesity therapies. The…
    Fierce Biotech · 15d agoPositive↗ source
  • Analysts Question Biogen's Lupus Drug Litifilimab Ahead of Key Phase 3 Readouts
    Analysts pressed Biogen CEO Chris Viehbacher during a recent call, focusing on the company's late‑stage pipeline. The discussion centered on litifilimab, Biogen’s experimental lupus therapy, with…
    Endpoints · 16d agoNeutral↗ source
  • FDA releases draft guidance to streamline approval of personalized gene therapies
    The FDA announced a draft guidance aimed at expanding access to gene therapies that target different mutations within the same disease. The proposal outlines an "individualized feature space" that…
    BioPharma Dive · 16d agoRegulatoryPositive↗ source
  • FDA proposes new rare disease framework to accelerate therapy development
    During a public hearing, FDA officials outlined a newly proposed rare disease framework aimed at creating a lasting regulatory scheme. The initiative seeks to speed the development of safe and eff…
    Fierce Biotech · 16d agoRegulatoryPositive↗ source
  • Chinese biotech BioGeometry secures over $100 million Series A for AI-driven protein design
    BioGeometry, a four-year-old biotech startup based in Beijing, announced it has closed a Series A financing round of more than $100 million. The capital will be used to expand its artificial-intel…
    Endpoints · 16d agoDealPositive↗ source
  • Eli Lilly to merge U.S. and international units after exec retirement; Novartis records $1.9B impairment on failed Avidity drug
    Eli Lilly announced that its U.S. and international divisions will be combined into a single unit called "Lilly Global Markets" after the retirement of long‑time executive Patrik Jonsson at the end…
    BioPharma Dive · 16d agoNeutral↗ source
  • Biogen CEO says early-stage R&D now a priority after record five INDs this year
    Biogen's chief executive Chris Viehbacher told analysts that the company has shifted its strategy toward early-stage research and development. He highlighted that Biogen has filed five investigati…
    Fierce Biotech · 16d agoPositive↗ source
  • Flagship launches Etcelera, an AI-driven biotech combining three platforms to predict drug effects
    Flagship Pioneering announced the formation of Etcelera, a new biotech emerging from stealth that will focus on AI-powered drug discovery. The company brings together the technologies of Cellarity…
    Fierce Biotech · 15d agoPositive↗ source
  • Zocdoc pushes AI personal agents into healthcare as other sectors restrict their use
    Zocdoc is positioning AI personal agents to take on patient‑focused tasks, signaling a new direction for health‑tech services. While Amazon, Delta Air Lines and several major U.S. banks have block…
    Endpoints · 15d agoPositive↗ source
  • Survey finds 78% of scientists expect AI to accelerate drug discovery this year
    Endpoints Signal surveyed roughly 1,500 biopharma insiders about AI's near-term impact on drug discovery. The respondents included a broad mix of industry roles. While scientists had been the most…
    Endpoints · 16d agoPositive↗ source
  • Astellas secures exclusive option on Audax Biosciences preclinical IL-12 cancer drug
    Astellas has taken an exclusive option to license a preclinical immuno-oncology asset from Audax Biosciences, an Australian biotech company. The asset is an IL-12 based cancer therapeutic that is…
    Endpoints · 16d agoDealNeutral↗ source
  • GSK says UK restructuring will have limited impact on staff, focusing cuts on support roles
    GSK executives said the company's global restructuring will only modestly affect UK staff, mainly targeting support functions at headquarters. CEO Luke Miels explained during the Q3 earnings call…
    Fierce Biotech · 16d agoLayoffsNegative↗ source
  • FDA issues draft guidance for electronic IDE submissions via eSTAR
    The U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Reso…
    raps · 16d agoRegulatoryNeutral↗ source
  • HHS pauses enforcement of ban on compounding wellness peptides as FDA drafts new rules
    HHS announced it will temporarily stop enforcing the existing prohibition on the compounding of certain peptides marketed for wellness. The agency said the move is intended to protect consumer saf…
    Endpoints · 15d agoRegulatoryNeutral↗ source