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22 stories matching this filter · ← front page

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  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 2d agoLayoffsNegative↗ source
  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 4d agoRegulatoryNeutral↗ source
28
fda medwatch21
fda press21
fda recalls18
570
Vaccines507
Endocrinology & Metabolism289
Ophthalmology255
Infectious Disease252
Nephrology234
  • 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…
    raps · 7d 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 · 7d 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 · 8d ago↗ source
  • Celldex ends skin disease program after failing phase 2 test
    A phase 2 study of Celldex’s barzolvolimab in a chronic skin disease has missed its primary endpoint, driving the biotech to end development in the indication and raising doubts about an upcoming e…
    Fierce Biotech · 9d ago↗ source
  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    BioSpace · 10d ago↗ source
  • 2026 IPO class blooms again as BlossomHill, Latigo set sights on Nasdaq
    Eighteen companies have gone public this year so far, putting 2026 on pace to record the highest number of IPOs since the pandemic-driven high of 2021.
    BioSpace · 11d ago↗ source
  • Kolon’s cell-based gene therapy fails phase 3 osteoarthritis trial
    A phase 3 trial of Kolon TissueGene’s cell-based gene therapy has missed its co-primary endpoints. With a second late-stage study scheduled to report data in October, the biotech is holding off on…
    Fierce Biotech · 11d ago↗ source
  • Latigo preps IPO to fund non-opioid pain drug rival to Vertex’s Journax
    Latigo Biotherapeutics is preparing to go public in order to bankroll the development of its clinical-stage pipeline of non-opioid pain management drugs.
    Fierce Biotech · 12d ago↗ source
  • Biotronik Neuro snaps up spinal cord stimulation portfolio from Soin Neuroscience for next-gen pain project
    Biotronik Neuro has acquired a portfolio of spinal cord stimulation patents from the Ohio-based medical device company Soin Neuroscience as the pair look to create “a next-generation spinal cord st…
    Fierce Biotech · 14d ago↗ source
  • The future of pain relief: Exploring opioid alternatives
    In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has…
    BioSpace · 15d ago↗ source
  • FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
    The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recu…
    fda press · 29d ago↗ source
  • FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
    FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…
    fda press · 1mo ago↗ source
  • FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
    The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an in…
    fda press · 1mo ago↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 2mo ago↗ source
  • Honesty and Humor Provide Hope in Breast Cancer Survivorship: With Sara Nunnery, MD, MSCI; and Annie Bond
    Dr Nunnery and Annie Bond discuss breast cancer survivorship and patient advocacy.
    onclive · 2mo ago↗ source
  • Dr Randall on the Rationale for Investigating CSF-1R Inhibition in TGCT
    R. Lor Randall, MD, FACS discusses safety and efficacy data from the MANEUVER trial, which evaluated pimicotinib in TGCT.
    onclive · 2mo ago↗ source
  • The OncFive: Top Oncology Articles for the Week of 5/3
    The FDA clears zenocutuzumab in NRG1 fusion+ cholangiocarcinoma, accepts a taletrectinib NDA in ROS1+ NSCLC for review, and more.
    onclive · 2mo ago↗ source
  • Dr Randall on Long-Term Responses and Functional Benefits With Pimicotinib in TGCT
    R. Lor Randall, MD, FACS discusses safety and efficacy data from the MANEUVER trial, which evaluated pimicotinib in TGCT.
    onclive · 2mo ago↗ source
  • FDA Approves Zenocutuzumab for NRG1 Fusion+ Cholangiocarcinoma
    onclive · 2mo ago↗ source
  • MANEUVER Trial Underscores Potential Paradigm Shift Toward Targeted Approaches in TGCT
    R. Lor Randall, MD, FACS, discusses how the introduction of systemic therapies like pimicotinib in TGCT enables a tumor biology–informed approach to care.
    onclive · 2mo ago↗ source