Drug Approval | February 21, 2025
USFDA classifies Aurobindo Pharma Inc's warehouse as OAI
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
The inspection was successfully completed
the inspection conducted from January 27 to January 31, 2025
The Alathur facility specializes in the production of Cephalosporin antibiotics
Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
Innovative chronic pain treatment receives IP protection in India's $55 billion pharmaceutical market
Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W and Y)
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure
Glenmark’s Clindamycin Phosphate Foam, 1% is bioequivalent and therapeutically equivalent to Evoclin Foam, 1%, of Mylan Pharmaceuticals.
Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries
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