United States Food and Drug Administration
Facing added pressure from Eli Lilly, Novo Nordisk submits for FDA approval of oral GLP-1 obesity drug
Nordisk, Obesity, Approved, Oral cavity, Glucagon-Like Peptide 1, Market, Pressure- physical agent, eli lilly, competition, Novo, semaglutide, United States Food and Drug Administration, United States Food and Drug Administration
Dupixent notches seventh disease approval with urticaria nod
Dupixent, Chronic Spontaneous Urticaria, Approved, Urticaria, United States Food and Drug Administration, seventh
Chinese CRO GemPharmatech expands in San Diego as industry weighs FDA’s animal testing shift
United States Food and Drug Administration, GemPharmatech, Contract Research Organization, San Diego, Animal Testing, mouse models, expansion, Industry
FDA rejection of extended dosing interval is another piece of bad news for Regenerons Eylea HD
United States Food and Drug Administration, Interval, Regeneron, dosing, Extension, Eylea HD, rejection, Age related macular degeneration, Diabetic Retinopathy
FDA moves to block biopharma employees from serving on advisory committees
United States Food and Drug Administration, Workers, Advisory Committees, Industry, Policy
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.