Qualitative Concept
FDA Approves Johnson & Johnson’s Imaavy: A New Treatment Option for Generalized Myasthenia Gravis
Imaavy, nipocalimab-aahu, FcRn blocker, generalized myasthenia gravis (gMG), FDA approval, Johnson & Johnson, autoimmune disease, IgG reduction
Novartis to buy Regulus Therapeutics for up to $1.7B
Goldcrest, Novartis, Acquisition (action), Kidney Diseases
FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts
United States Food and Drug Administration, PDUFA, Impact food supplement, Approved, Agencies, questions
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
Pfizer’s Bourla is ‘cautiously optimistic’ on tariffs, says M&A is on the table
Bourla, M&A, Pfizer, United States, TNFRSF19 gene, Policy, tariffs
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
Merck & Co. breaks ground on $1B future US home of Keytruda
United States, Keytruda, Home environment, Merck, Wilmington, Biological Factors
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
AstraZeneca’s China woes recede as focus shifts to upcoming readouts
$2.5 billion R&D investment in Beijing, Global strategic R&D center, China legal issues resolution, Biotech partnerships, Manufacturing expansion, $8 million potential fine, FibroGen China acquisition