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D.C. Circuit Raises Bar for Generic Drug Exclusivity

[ Price : $8.95]

An appeals court appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after mis...

FDA, Regulatory Partners Agree on Alternative Endotoxin Test

[ Price : $8.95]

FDA and the International Coalition of Medicines Regulatory Authorities complete an assessment of a new biologics testing approach...

Rules Needed on Complete Response Letter Transparency: Researchers

[ Price : $8.95]

Researchers say clear rules are needed for when FDA decides to publicly release complete response letters.

IDEAYA Plans Phase 3 Study in Lung Cancer After FDA Meeting

[ 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...

Karyopharm sNDA Filed for Xpovio in Myelofibrosis

[ Price : $8.95]

Karyopharm Therapeutics files a supplemental NDA seeking accelerated approval for Xpovio (selinexor) in combination with ruxolitin...

FDA, SEC Sign MOU on Sharing Info on Medical-Product Companies

[ Price : $8.95]

FDA and the U.S. Securities and Exchange Commission sign an MOU to strengthen cooperation and share information involving compani...

First Oral Drug Indicated to Treat Dermatomyositis Approved

[ Price : $8.95]

The agency approves Priovant Therapeutics Lisraya (brepocitinib) tablets for treating dermatomyositis in adults.

Alert on Boston Scientifics Angiographic Catheters

[ Price : $8.95]

FDA issues an Early Alert after becoming aware that Boston Scientific sent a letter to customers recommending all Imager II Angiog...

FDA OKs Lilly's Mounjaro to Reduce CV Risk in Adults with Diabetes

[ Price : $8.95]

FDA approves Eli Lillys Mounjaro (tirzepatide) for lowering the risk of major adverse cardiovascular events.

FDA Approves Updated Covid-19 Vaccines for Upcoming Season

[ Price : $8.95]

FDA approves updated Covid-19 vaccines from Moderna, Pfizer-BioNTech and Novavax/Sanofi for the upcoming vaccination season.