Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure

FDA grants EUA to Aptitude’s Covid/flu multiplex test for OTC use

Zydus receives final approval from USFDA for Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg

Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis

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

Lupin receives EIR from USFDA for its Somerset manufacturing facility

the inspection conducted from January 27 to January 31, 2025

USFDA issues Form-483 for Piramal Pharma's facility at Turbhe

Observations are largely around improvement of procedures and practices

Orchid Pharma's Alathur API facility successfully completes USFDA inspection

The Alathur facility specializes in the production of Cephalosporin antibiotics

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer

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

GSK’s Penmenvy approved by FDA to help protect against MenABCWY

Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W and Y)

FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy

Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries