Temporal Concept
FDA chief Makary talks expediting drug approvals, RIFs and the abortion pill
United States Food and Drug Administration, Califf, Unspecified Abortion, Contraceptives, Oral, Accelerated, Artificial Intelligence, RIFs, Infrequent, Agencies
AbbVie’s Rinvoq cleared for giant cell arteritis in US
Giant Cell Arteritis, Rinvoq, upadacitinib, Approved, Janus kinase, Inhibitor, United States Food and Drug Administration, Steroids
Abeona’s $3.1M gene therapy wins FDA nod for rare skin disease
United States Food and Drug Administration, United States Food and Drug Administration, Infrequent, ZEVASKYN, Abeona, gene therapy, Dermatologic disorders, Hallopeau-Siemens Disease, Approved, Abeona ‘s
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