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Results For "USFDA"

1314 News Found

Merck’s DOR/ISL regimen shows minimal impact on weight and lipids in phase 3 HIV studies
Clinical Trials | October 16, 2025

Merck’s DOR/ISL regimen shows minimal impact on weight and lipids in phase 3 HIV studies

These findings follow positive Phase 3 results presented earlier this year


FDA approves AbbVie’s Upadacitinib for treatment of inflammatory bowel disease
Drug Approval | October 14, 2025

FDA approves AbbVie’s Upadacitinib for treatment of inflammatory bowel disease

Updated indication expands treatment options for patients with ulcerative colitis and Crohn’s disease when tumor necrosis factor (TNF) blockers are clinically inadvisable


Lupin launches partnership program to expand global reach of PrecisionSphere injectable platform
News | October 09, 2025

Lupin launches partnership program to expand global reach of PrecisionSphere injectable platform

Lupin's partnership program is designed to foster collaborations with companies looking to extend their product lifecycles


Biocon and Carnegie receive FDA tentative approval for Rifaximin tablets
Drug Approval | October 07, 2025

Biocon and Carnegie receive FDA tentative approval for Rifaximin tablets

Rifaximin tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy


Zydus receives approval from Health Canada for Liothyronine tablets 5 mcg and 25 mcg
Drug Approval | October 07, 2025

Zydus receives approval from Health Canada for Liothyronine tablets 5 mcg and 25 mcg

Liothyronine tablets will be manufactured at Zydus' plant in Ahmedabad SEZ


FDA approves Zydus’ Deflazacort oral suspension, 22.75 mg/mL
Drug Approval | October 07, 2025

FDA approves Zydus’ Deflazacort oral suspension, 22.75 mg/mL

Deflazacort oral suspension is indicated for treating Duchenne Muscular Dystrophy in patients 5 years of age and older


BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease
Drug Approval | October 05, 2025

BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease


A. P. Rameswara Rao appointed National President of BDMAI
People | October 03, 2025

A. P. Rameswara Rao appointed National President of BDMAI

A Post Graduate in Science faculty and has a wide experience spanning over 35 years in the field of manufacturing Bulk Drugs and Active Pharmaceutical Intermediaries


Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections
Drug Approval | October 01, 2025

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company