[ Price : $8.95]
FDA tells Aquestive Therapeutics that deficiencies have been identified in the companys NDA for Anaphylm that currently preclude l...[ Price : $8.95]
FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a once-monthly treatment for acromegaly.[ Price : $8.95]
A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Squibbs Karuna Therapeutics unit u...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion sends BeOne Medicines USA an untitled letter over its promotional materials for cancer...[ Price : $8.95]
Representatives of FDA and the drug industry make progress in PDUFA 8 discussions on real-world evidence and metrics for first-cyc...[ Price : $8.95]
A new analysis from Harvard Law School argues that the U.S. drug regulators reliance on industry-paid user fees has left the agenc...[ Price : $8.95]
FDA approves 46 novel new drugs and 18 new biologics in 2025, fewer than in the previous two years, likely due to the staffing tur...[ Price : $8.95]
GSK says its investigational hepatitis B drug bepriovirsen met the primary endpoint in two pivotal Phase 3 trials, with regulatory...