United States Food and Drug Administration
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
Annexon Advances Guillain-Barré Syndrome Awareness and Introduces Groundbreaking Targeted Therapy
Guillain-Barré Syndrome (GBS) , Annexon , Tanruprubart (ANX005) , Targeted therapy , GBS education campaign , Move GBS Forward™ , Phase 3 trial results , FDA approval
Former CBER head Peter Marks says he blocked RFK Jr. from vaccine safety database before leaving FDA: AP
Vaccines, Massive, Vaccine Safety, Kennedy, United States Food and Drug Administration, RFK Jr., Disease Outbreaks, Peter Marks, VAERS, Kennedy ‘s
: BMS’ Opdivo plus Yervoy snags FDA nod as first-line treatment for certain colorectal cancer patients
United States Food and Drug Administration, Approved, Burning Mouth Syndrome, Colorectal Carcinoma, Yervoy, first-line, Combined
Novavaxs held-up approval package may signal warning for Covid vaccine makers
Vaccines, Approved, COVID19 (disease), United States Food and Drug Administration, Market, Novavax ‘s, Maker (occupation), Deferred
FDA official said to step in and pause review of Novavax’s COVID-19 vaccine
United States Food and Drug Administration, COVID19 (disease), Vaccines, Novavax ‘s, Review [Publication Type], Novavax, Approved