Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India Limited, has received Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets in strengths of 3.1 mg, 6.3 mg, 9.4
Granules India Limited announced that its US step-down subsidiary, Granules Consumer Health, LLC, a wholly-owned subsidiary of Granules Pharmaceuticals, Inc., successfully completed a GMP inspection by the U.S. Food and Drug Administration (FDA) with zero observations.This was the facility’s second FDA inspection, following the March
Outside advisers to the U.S. Food and Drug Administration on Friday unanimously recommended the agency authorize a second shot of Johnson & Johnson's (JNJ.N) COVID-19 vaccine for all recipients of the one-dose inoculation.The agency is also considering lowering the recommended age for booster shots of the Pfizer (PFE.N)/BioNTech
The U.S. Food and Drug Administration has declined Humanigen Inc's (HGEN.O) request for emergency use authorization (EUA) of its lenzilumab drug to treat newly hospitalized COVID-19 patients, as stated by the company on Thursday."In its letter, FDA stated that it was unable to conclude that the known
