Merck KGaA’s Cladribine capsules gain FDA fast track for rare neuromuscular disorder

Zydus receives FDA’s final approval for Verapamil Hydrochloride ER tablets

Lupin receives 7 observations from USFDA for Goa manufacturing facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels

FDA nod to groundbreaking bladder cancer combo therapy for surgery patients

Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options

Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets

Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhoea

Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia

NATCO Pharma receives 7 observations from USFDA for API unit at Manali

FDA investigates fatal case linked to rare blood disorder drug Adzynma

Adzynma, approved for both adults and children with cTTP, is a recombinant enzyme therapy designed to replace the deficient ADAMTS13 enzyme

Solara’s Mangalore facility clears FDA inspection with VAI status