FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

Teva files FDA application for once-monthly schizophrenia injection

The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time

Merck Animal Health wins FDA’s fast-track green light for first-in-decades cattle parasite treatment

The topical fluralaner solution is cleared for the prevention and treatment of new world screwworm infestation

FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment

Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor

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

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

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

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