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13 stories matching this filter · ← front page

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  • Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine Ampules
    Argon Medical is correcting affected convenience kits by removing included Spectra Medical Devices Lidocaine Ampules.
    fda medwatch · 22h ago↗ source
  • 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 · 1d agoLayoffsNegative↗ source
28
fda medwatch21
fda press21
fda recalls18
395
Psychiatry & CNS340
Ophthalmology169
Infectious Disease165
Pain160
Nephrology159
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 · 9d 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 · 10d ago↗ source
  • Updated: BlossomHill and Latigo join flourishing IPO queue with cancer, pain drugs
    Last summer, zero biotechs made it onto the public markets as the industry weathered a seven-month dry spell for initial share sales. This time around, it's a summer IPO party as six
    Endpoints · 13d 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 · 14d ago↗ source
  • Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
    B. Braun is removing affected convenience kits containing recalled Bupivacaine Hydrochloride in Dextrose Injection components
    fda medwatch · 14d ago↗ source
  • Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline
    Saline, Lidocaine and Bupivacaine from affected convenience kits should not be used.
    fda medwatch · 14d 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
  • Lilly buys another pain biotech; FDA sets decision for once-weekly PrEP pill
    Plus, news about Merck, MultiValent Biotherapies, Alvotech, enGene, Mirum, and Adaptive Biotechnologies. 💸 Eli Lilly acquires another pain biotech: The Indianapolis pharma giant has made its 11th…
    Endpoints · 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