An appeals court appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after missing its FDA-mandate...
FDA and the International Coalition of Medicines Regulatory Authorities complete an assessment of a new biologics testing approach that could reduce u...
Researchers say clear rules are needed for when FDA decides to publicly release complete response letters.
IDEAYA Biosciences says it had a successful FDA Type C meeting to determine the Phase 3 rial design for IDE849 for treating extensive stage small cell...
Karyopharm Therapeutics files a supplemental NDA seeking accelerated approval for Xpovio (selinexor) in combination with ruxolitinib for patients with...
FDA and the U.S. Securities and Exchange Commission sign an MOU to strengthen cooperation and share information involving companies and products regu...
The agency approves Priovant Therapeutics Lisraya (brepocitinib) tablets for treating dermatomyositis in adults.
FDA issues an Early Alert after becoming aware that Boston Scientific sent a letter to customers recommending all Imager II Angiographic Catheters be ...
