Browsing Tag
drug approval
5 posts
Vanda Pharmaceuticals (VNDA) wins FDA’s first formal drug approval hearing in 40 years as Hetlioz jet lag battle enters new phase
FDA grants Vanda Pharmaceuticals a rare Part 12 public hearing on Hetlioz jet lag rejection, the first such drug approval hearing in 40 years. Read the full analysis.
Can Ascendis Pharma’s TransCon CNP still win FDA approval after the review extension?
FDA delays decision on Ascendis Pharma’s dwarfism drug TransCon CNP to February 2026 due to protocol revisions. See how this affects approval odds and launch.
Wockhardt secures approval for Miqnaf: A breakthrough in pneumonia treatment
In a landmark decision addressing the global challenge of antibiotic resistance, the Indian drug regulator, Central Drugs Standard…
FDA committee endorses Zevra Therapeutics’ arimoclomol as a treatment for Niemann-Pick Disease Type C
In a notable advancement for rare disease treatment, Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) has received a significant endorsement…
Vertex Pharmaceuticals’ suzetrigine approved for FDA review: A breakthrough in pain management
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) has announced a pivotal advancement in the treatment of acute pain. The U.S.…