In a watershed U.S. regulatory milestone, the MAPS Public Benefit Corporation announced Tuesday that it has submitted a New Drug Application to the FDA for an investigational MDMA-assisted therapy for individuals with post-traumatic stress disorder.
Tag Archive for: Breakthrough Therapy designation
Thursday, the FDA pushed back its target action date by three months for Daiichi Sankyo’s investigational acute myeloid leukemia (AML) drug quizartinib, citing updates to the proposed Risk Evaluation and Mitigation Strategies (REMS).
Novartis reported Thursday that a Phase III trial of iptacopan met its primary endpoint in paroxysmal nocturnal hemoglobinuria (PNH) – the company’s second win in this indication in as many months.
Jazz Pharmaceuticals and Zymeworks Inc. entered into a $50 million licensing agreement over zanidatamab, Zymeworks’ bispecific antibody targeting HER2, the companies announced Wednesday.
The FDA has approved Axsome Therapeutics’ Auvelity for major depressive disorder (MDD) in adults, making it the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for this indication.
Merck scored another big win Wednesday with a U.S. Food and Drug Administration approval for an expanded indication of Vaxneuvance, its pneumococcal 15-valent conjugate vaccine. The new indication includes children 6 weeks through 17 years of age.
New York-based Axsome Therapeutics published results from the pivotal Phase III Gemini trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD).
