Qualitative Concept – Page 46

Leqembi, Biogen and Eisai’s Alzheimer’s Drug, Gains UK Approval but Faces Cost-Effectiveness Hurdle

8 months ago talkbio0Tagged Alzheimer 's disease, Approved, Biogen, Cost Effectiveness, Eisai, Leqembi, Nitroglycerin/Sodium Citrate/Ethanol Solution, UK

Leqembi, Alzheimer’s disease, UK approval, NICE, cost-effectiveness, Biogen, Eisai

J&J’s Rybrevant Combination Approved for First-Line Treatment of EGFR-Mutated Non-Small Cell Lung Cancer

8 months ago talkbio0Tagged Approved, chemotherapy-free regimen, Epidermal Growth Factor Receptor, Johnson & Johnson, lazertinib, Mutation, Non-Small Cell Lung Carcinoma, Rybrevant, United States Food and Drug Administration

Rybrevant, Johnson & Johnson, FDA approval, non-small cell lung cancer, EGFR mutations, lazertinib, chemotherapy-free regimen

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

9 months ago talkbio0Tagged Associated with, Lung Diseases, Interstitial, PH-ILD, Pulmonary arterial hypertension, Pulmonary Hypertension, regulatory exclusivity, Tentative Approval, Tyvaso, United States Food and Drug Administration, United Therapeutics, YUTREPIA

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

FDA Clears BioNTech-MediLink ADC Trial to Resume with Reduced Doses

9 months ago talkbio0Tagged ADC, Approved, BioNTech, Cancer Therapeutic Procedure, Clinical Trials, ERBB3 Receptor Protein-Tyrosine Kinase, lower doses, MediLink, patient safety, therapeutic autologous dendritic cells, United States Food and Drug Administration

BioNTech, MediLink, ADC trial, FDA approval, lower doses, cancer treatment, HER3, patient safety

Embracing Agility: Critical for the Role of QARA Professional

9 months ago talkbio0Tagged Access, Agility, AI, Artificial Intelligence, Communication, Diversity, Inclusion, Leadership, Market, professional occupation status, QARA, quality assurance, Regulatory Affairs, regulatory strategy, Technology

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