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9151 News Found

USFDA classifies Aurobindo Pharma Inc's warehouse as OAI
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


Korea’s MFDS completes inspection at Concord Biotech's Dholka unit
Drug Approval | February 21, 2025

Korea’s MFDS completes inspection at Concord Biotech's Dholka unit

The inspection was successfully completed


European Commission approves Biocon Biologics' Ustekinumab Biosimilar
News | February 21, 2025

European Commission approves Biocon Biologics' Ustekinumab Biosimilar

YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease


Lupin receives EIR from USFDA for its Somerset manufacturing facility
Drug Approval | February 21, 2025

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
Drug Approval | February 21, 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
Drug Approval | February 20, 2025

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
Drug Approval | February 20, 2025

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


Innocan Pharma granted first patent in India for its Liposomal CBD Injection
News | February 20, 2025

Innocan Pharma granted first patent in India for its Liposomal CBD Injection

Innovative chronic pain treatment receives IP protection in India's $55 billion pharmaceutical market


IMCD showcases ‘Skinification’ trend at HPCI India 2025
News | February 19, 2025

IMCD showcases ‘Skinification’ trend at HPCI India 2025

IMCD India’s innovative formulations bring the Skinification trend to life with cutting-edge solutions across beauty and personal care