August 19, 2024
FDA Clears BioNTech-MediLink ADC Trial to Resume with Reduced Doses
BioNTech, MediLink, ADC trial, FDA approval, lower doses, cancer treatment, HER3, patient safety
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
Genentech Closes Cancer Immunology Unit as Part of Broader R&D Restructuring
Genentech, Cancer Immunology, R&D Reprioritization, Roche, Cancer Research, Molecular Oncology
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.
Novo Nordisk Invests $221 Million in New Danish Plant to Enhance Supply Chain
Novo Nordisk, supply chain, Danish plant, investment, pharmaceuticals