Finding
FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review
Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.
J&J Scores First-Line Approval for Rybrevant Combination in Lung Cancer with EGFR Exon 20 Mutations
Johnson & Johnson, Rybrevant (amivantamab-vmjw), FDA Approval, First-Line Treatment, Non-Small Cell Lung Cancer (NSCLC), EGFR Exon 20 Insertion Mutations, Carboplatin-Pemetrexed Chemotherapy, Phase 3 PAPILLON Study, Reduced Disease Progression or Mortality Risk, Improved Objective Response Rate (ORR) and Progression-Free Survival (PFS)
Minerva’s Roluperidone for Schizophrenia Symptoms Denied Approval by FDA
United States Food and Drug Administration, MFSD1 gene, Symptoms aspect, Schizophrenia, New Drug Application
Janux Shares Surge Over 200% on Promising Early Signs of PSA Response in Prostate Cancer Treatment
Prostate-Specific Antigen, Janux, JANX007, Malignant neoplasm of prostate
ViiV’s Long-Acting Cabenuva Outperforms Daily Oral Therapy in Phase III Study
cabenuva, Daily, Standard of Care, Adherence (attribute), HIV, Participant, daily
Bayer Implements 95% Dividend Cut to Reduce Debt Amid CEO Bill Anderson’s Turnaround Plan
Bayer, Euro currency, Reduced, 95%
FDA Approves Xolair (Omalizumab) for Reducing Severe Outcomes from Multiple Food Allergies
Xolair, United States Food and Drug Administration, omalizumab, Hypersensitivity, Food, Reduced, Severe (severity modifier)
Eicos Sciences’ Aurlumyn: First FDA-Approved Treatment for Severe Frostbite Reduces Amputation Risk
Aurlumyn, Eicos, Amputation, Sciences’, iloprost, severe frostbite
Amgen’s obesity drug takes the weight off and may keep it off, too, early data suggest
Obesity, MariTide, Weight Loss, Source, Amgen’s, weight off
UPDATE: Vertex beats own record in cystic fibrosis as next-gen treatment goes up against Trikafta
Cystic Fibrosis, Trikafta, vanza, Vertex, next-gen, Records