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186 stories matching this filter · ← front page

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  • 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 · 6d 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 · 6d 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…
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fda press21
fda recalls20
fda medwatch16
Hematology6
Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
BioSpace · 6d 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 · 6d 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 · 6d ago↗ source
  • Scancell to go public after winning reverse merger bid for troubled Neuphoria
    Scancell and Neuphoria have made their union official via a reverse merger that will result in a Nasdaq listing for Scancell and a resolution for Neuphoria’s shareholders after the biotech ended it…
    Fierce Biotech · 6d ago↗ source
  • Lilly’s triple-G drug hits 22.6% weight loss, but impact on reducing cardio risk is less clear
    Eli Lilly’s triple-G drug retatrutide has hit the primary endpoints of a pair of phase 3 obesity trials, although the peak weight loss fell short of previous trials while failing to prove the drug…
    Fierce Biotech · 6d ago↗ source
  • Roche Diagnostics growth remains muted amid China headwinds
    Roche’s Diagnostics division continues to battle growth headwinds, notching a 3% increase in sales.
    Fierce Biotech · 6d 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
  • Australian biopharma Clinuvel to shed up to 20% of workforce in move to US
    Australian biopharma Clinuvel Pharmaceuticals is moving its headquarters to the U.S.— but up to a fifth of the company’s workforce won’t be staying for the trans-Pacific pivot.
    Fierce Biotech · 7d ago↗ source
  • Roche drops TCE for lupus, but hasn’t given up on autoimmune cell therapies
    Roche may have scrapped work on a T-cell engager being evaluated for lupus, but the company’s head of pharma told Fierce that still has a strategy for developing cell therapies for autoimmune disea…
    Fierce Biotech · 7d ago↗ source
  • FDA clears Johnson & Johnson’s surgical robot for ‘the next era in surgery’
    The FDA has authorized Johnson & Johnson’s Ottava Robotic Surgical System as the company looks to compete with Intuitive Surgical and Medtronic.
    Fierce Biotech · 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
  • 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 · 7d 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 · 7d ago↗ source
  • NIH joins Trump’s $5B AI mission with biomedical research push
    The U.S. Department of Health and Human Services announced new efforts Wednesday aligned with President Donald Trump’s artificial intelligence-driven Genesis Mission. The centerpiece of HHS’ partic…
    Fierce Biotech · 7d 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 · 7d ago↗ source
  • Repligen strikes $1.5B BioLife buyout to bag cell therapy product pharmas rely on
    Top-selling cell therapies from BMS, J&J and Gilead depend on a BioLife product, positioning Repligen to use the takeover to increase its exposure to the modality.
    BioSpace · 7d ago↗ source
  • 6 companies hiring in Cambridge now
    Looking for a biopharma job in Cambridge? Roles posted on BioSpace have more than doubled compared to last year.
    BioSpace · 7d ago↗ source
  • FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
    The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again.
    fda press · 7d ago↗ source
  • US ‘eroding’ lead in rare diseases a matter of national security: Report
    A Congressional advisory panel recommends the U.S. government put supportive policies in place for rare disease drug development, such as a finalized platform designation from the FDA and the allow…
    BioSpace · 7d ago↗ source
  • Novartis scraps mid-stage radiopharma asset as Pluvicto soars
    The discontinued asset, being trialed for breast cancer and solid tumors, had yielded disappointing data, leading to Novartis’ decision to abandon development, according to a company spokesperson.
    BioSpace · 7d ago↗ source
  • Q2 earnings underway, FDA’s CRL kerfuffle, IPOs full speed ahead in H2
    Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics spa…
    BioSpace · 7d ago↗ source
  • House passes bill directing FDA to update animal testing rules
    The U.S. House of Representatives passed the FDA Modernization Act 3.0 this week, and lawmakers and animal welfare advocates are celebrating the bill as a step toward a new era in preclinical testi…
    Fierce Biotech · 7d ago↗ source