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  • Scribe secures $129M in a rare gene editing IPO
    The startup is the first gene editing company to price an IPO in more than two years, though it banked far less than most other biotechs that have gone public in 2026.
    BioPharma Dive · 6d ago↗ source
  • FDA panel endorses broader use of certain peptides
    In a victory for Robert F. Kennedy Jr.’s “MAHA” agenda, panelists narrowly recommended broader use of six of the seven peptides up for consideration despite a lack of substantive evidence supportin…
    BioPharma Dive · 6d ago↗ source
  • This Week at FDA: Diamantas touts onshoring efforts, grants for DHTs, and more
    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This we…
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fda medwatch17
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Hematology6
Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
raps · 6d ago
↗ source
  • FDA advisory committee backs two more peptides, rejects one for compounding list
    By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was tasked…
    raps · 6d ago↗ source
  • Update: FDA does not freeze CRL trove as ‘radical transparency’ push hits speedbump
    An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
    BioSpace · 7d ago↗ source
  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health.
    BioPharma Dive · 7d ago↗ source
  • BeOne commits $300M to US manufacturing expansion, creating 120 new jobs
    The addition of small molecule capacity at BeOne Medicines’ Hopewell site will support the company’s hematology efforts and bring total investment in the campus to more than $1 billion.
    BioSpace · 7d ago↗ source
  • Lilly preps FDA run for ‘triple-G’ weight loss drug with Phase 3 data
    With weight loss topping 20% at 80 weeks in the Phase 3 TRIUMPH-2 and TRIUMPH-3 trials, Eli Lilly plans to file for retatrutide’s approval in the first quarter of 2027. Previously a filing was expe…
    BioSpace · 7d ago↗ source
  • Roche's late stage pipeline 'so full,' CEO Schinecker not feeling pressure to add on
    Roche has 19 investigational medicines that could launch by 2030—and even if not all of them make it to market, the company is “well set-up for growth into the next decade,” CEO Thomas Schinecker s…
    BioSpace · 7d ago↗ source
  • GSK’s $10.6B Nuvalent bet pays off early as FDA approves lung cancer drug
    Jideytro is GSK’s first approved product for lung cancer. With its takeover of Nuvalent Bio last month and a deal with Hansoh Pharmaceutical in 2023, the pharma now has several other lung cancer as…
    BioSpace · 7d ago↗ source
  • Nordic biotech’s next act: From fragmentation to global force
    In this episode of Denatured, you’ll hear from Ester Sklarsky, principal at Sound Bioventures and João Ribas, partner at Novo Holdings Seed Investments. In this episode, we explore the diverging tr…
    BioSpace · 7d ago↗ source
  • Make or break: Commercial hires critical for success
    With the stakes for successful launches high, and demand for commercial roles increasing, biopharmas must thoughtfully approach not only hiring but also retention. During a BioSpace webinar, experi…
    BioSpace · 7d ago↗ source
  • Biopharma layoffs must double in H2 for 2026 to match 2025 cuts
    With fewer biopharmas making or planning workforce reductions so far year over year, layoff round size and M&A impact on headcounts will likely shape the number of employees who are ultimately on t…
    BioSpace · 7d ago↗ source
  • Recon: J&J nabs FDA authorization for general surgery robot; FDA urged to ban DTC drug ads
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 7d ago↗ source
  • Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studies
    The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.
    raps · 7d ago↗ source
  • Study: Most sponsors complete postmarketing trials, publish results
    Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the tim…
    raps · 7d ago↗ source
  • FDA advisory committee backs two controversial peptides
    An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for wound t…
    raps · 7d ago↗ source
  • Webinar: From Clinical to Commercial: Talent Strategies for Biopharma Growth
    This webinar provides an assessment of recent job market activity across biopharma and explores how companies approaching commercial readiness or building out sales and marketing teams can navigate…
    BioSpace · 7d ago↗ source
  • Vertex was sole bidder in high-premium Crinetics acquisition
    Analysts expect new details on the lead-up to the deal “are likely to reignite” investor scrutiny that Vertex overpaid in what’s poised to be its largest-ever transaction.
    BioPharma Dive · 7d ago↗ source
  • GSK lung cancer drug gets speedy approval following $10.6B deal
    The clearance is GSK’s first for a lung cancer medicine and the latest step forward in a yearslong push by the British drugmaker into oncology.
    BioPharma Dive · 7d ago↗ source
  • FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
    The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
    fda press · 8d ago↗ source
  • Arrowhead hits ‘best-case scenario’ with latest results for fat-lowering drug
    To analysts, the drug’s apparent safety and effects on both triglyceride levels and pancreatitis cases should make it competitive with a rival Ionis therapy.
    BioPharma Dive · 8d ago↗ source
  • Summit and Akeso sharpen case for ivonescimab with new Western data
    Summit Therapeutics and Akeso are answering questions raised about ivonescimab’s ability to translate to Western populations, though the partners have yet to share if the new findings are statistic…
    BioSpace · 8d ago↗ source
  • Trump threatens tariffs on imported generic drugs
    While the possibility of levies on branded pharmaceuticals have had a limited impact on drugmaker revenues, tariffs of up to 200% on copycat medicines could — depending on the specifics — prove mor…
    BioPharma Dive · 8d ago↗ source
  • Arrowhead puts pressure on Ionis with positive data for triglyceride lowering drug
    With Phase 3 data showing what analysts called a “potentially best-in-class profile,” Arrowhead Pharmaceuticals plans to submit for FDA approval of plozasiran by the end of the year—hoping to follo…
    BioSpace · 8d ago↗ source