FDA Grants Tentative Approval for YUTREPIA, a New Treatment for Pulmonary Arterial Hypertension and Pulmonary Hypertension Associated with Interstitial Lung Disease

YUTREPIA, treprostinil, pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), FDA tentative approval, regulatory exclusivity, United Therapeutics, Tyvaso

FDA’s Rejection of Lykos’ MDMA-Assisted Therapy for PTSD: A Setback but Not a Roadblock for Psychedelic Research

MDMA, PTSD, Lykos Therapeutics, FDA rejection, psychedelic therapy, clinical trials, ethical violations, scientific integrity.

Embracing Agility: Critical for the Role of QARA Professional

QARA Professional, Agility, Quality Assurance, Regulatory Affairs, Market Access, Innovative Therapeutic Solutions, AI, Technology, Regulatory Strategy, Leadership, Communication, Diversity, Inclusion.

Merck Acquires Curon’s Bispecific Antibody in $1.3B Deal; Legend Biotech Evaluates Options Amid Probes; Amgen’s FDA Filing Reveals Missing Adverse Events

Merck, Curon Biopharmaceutical , Bispecific antibody, Legend Biotech, Amgen, FDA filing, Adverse events, China investigations, CAR-T therapy, Carvykti