Temporal Concept
FDA decision on Stealth’s Barth syndrome drug delayed, again
United States Food and Drug Administration, 3-Methylglutaconic aciduria type 2, Decision, Elamipretide
FDA approves Abeonas skin disease cell therapy
ZEVASKYN, United States Food and Drug Administration, Hallopeau-Siemens Disease, Approved, Wounds – qualifier, gene therapy, Abeona, Treating
Keytruda around head and neck cancer surgery cuts chance of disease coming back
Keytruda, Head, perioperative, Episodic
Caribou cuts 32% of staff, further purges pipeline to focus on 2 oncology CAR-T prospects
Reindeer, CAR-T, Staff, Neoplasms, Cell Therapy, Allogeneic CRISPR-edited Anti-CD19 CAR-T Cells CB-010, Clustered Regularly Interspaced Short Palindromic Repeats, Leukemia, Myelocytic, Acute, United States Food and Drug Administration, 32%
Merck KGaA closes in on SpringWorks deal at $3.5B price point
SpringWorks, Acquisition (action), KGaA, Infrequent, Gomekli, deal, Merck
Facing added pressure from Eli Lilly, Novo Nordisk submits for FDA approval of oral GLP-1 obesity drug
Nordisk, Obesity, Approved, Oral cavity, Glucagon-Like Peptide 1, Market, Pressure- physical agent, eli lilly, competition, Novo, semaglutide, United States Food and Drug Administration, United States Food and Drug Administration
FDA rejection of extended dosing interval is another piece of bad news for Regenerons Eylea HD
United States Food and Drug Administration, Interval, Regeneron, dosing, Extension, Eylea HD, rejection, Age related macular degeneration, Diabetic Retinopathy
Lilly’s oral GLP-1 succeeds in first Phase III test, delivering promising weight loss
orforglipron, Glucagon-Like Peptide 1, Weight Loss, Oral cavity, orforglipron, Phase 3 Clinical Trials, Diabetes Mellitus, Non-Insulin-Dependent, Hemoglobin A1c measurement, Safety, Injectables
FDA clears its first prescription migraine app, from Click Therapeutics
United States Food and Drug Administration, CT-132, Migraine Disorders, Click Therapeutics, click, first