United States Food and Drug Administration
RFK Jr.’s FDA staff cuts claimed key user fee negotiators, threatening renewal talks with pharma: Reuters
United States Food and Drug Administration, Does speak, Staff, negotiators, HHS, Mediation, user fee, Fees, Drug Industry
FDA clears its first prescription migraine app, from Click Therapeutics
United States Food and Drug Administration, CT-132, Migraine Disorders, Click Therapeutics, click, first
Former FDA Officials Sound Alarm: Visible Changes May Be Tip of the Iceberg
United States Food and Drug Administration, public health medicine (field), Changing, Vaccines, Leadership, Policy, drug safety, Previous, KAT5 wt Allele, Icebergs, Disease Outbreaks, Alarm device, Visible
Ayrmid misses deadline for detailed offer to top private equity bid for bluebird
Ayrmid, Family Turdidae (organism), gene therapy, Failed, Capital, proposal – intent, United States Food and Drug Administration, private equity, deadline
Sandoz Challenges Amgen in Antitrust Lawsuit to Launch Enbrel Biosimilar in the U.S.
Sandoz, Amgen, Enbrel, Erelzi, antitrust, biosimilar, etanercept, patent thicket, U.S. market, rheumatoid arthritis, competition, biologics, FDA approval.
Ironwood Pharmaceuticals’ Stock Plummets Following Layoffs and FDA Setback for Apraglutide
Ironwood Pharmaceuticals , apraglutide , short bowel syndrome (SBS) , Phase III trial , layoffs , FDA regulatory hurdle , stock plunge , strategic alternatives , Goldman Sachs , biotechnology
FDA Union Prepares for Negotiations as HHS Job Cuts Reshape Workforce
FDA layoffs, HHS restructuring, Union negotiations, Reduction in Force (RIF), Robert F. Kennedy Jr., FDA workforce reduction, HHS employee layoffs, Federal health agencies, Public health impact, Union advocacy
Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs
FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions
Dexcom extends G7 sensor wear time to 15 days with latest FDA nod
United States Food and Drug Administration, sensor (device), Continuous glucose monitoring, MSH5 gene, Accurate (qualifier), Extension, wear time, day
Tempest Seeks Strategic Partners to Launch Phase 3 Liver Cancer Trial Amid Funding Challenges
Tempest Therapeutics , Amezalpat , Phase 3 Trial , Liver Cancer (HCC) , Strategic Partnerships , Biotech Funding , PPAR⍺ Antagonist , Clinical Oncology , FDA Clearance , Tecentriq and Avastin Combination Therapy