SMS Pharmaceutical's associate company receives FDA approval for reformulated Ranitidine

The approval by the US FDA comes after extensive safety testing and manufacturing improvements

Zydus receives FDA’s tentative approval for Empagliflozin and Linagliptin tablets

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

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

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

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

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 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

Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER

Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis