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An appeals court appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after mis...[ Price : $8.95]
FDA and the International Coalition of Medicines Regulatory Authorities complete an assessment of a new biologics testing approach...[ Price : $8.95]
Researchers say clear rules are needed for when FDA decides to publicly release complete response letters.[ Price : $8.95]
IDEAYA Biosciences says it had a successful FDA Type C meeting to determine the Phase 3 rial design for IDE849 for treating extens...[ Price : $8.95]
Karyopharm Therapeutics files a supplemental NDA seeking accelerated approval for Xpovio (selinexor) in combination with ruxolitin...[ Price : $8.95]
FDA and the U.S. Securities and Exchange Commission sign an MOU to strengthen cooperation and share information involving compani...[ Price : $8.95]
The agency approves Priovant Therapeutics Lisraya (brepocitinib) tablets for treating dermatomyositis in adults.[ Price : $8.95]
FDA issues an Early Alert after becoming aware that Boston Scientific sent a letter to customers recommending all Imager II Angiog...