Alkem labs successfully completes USFDA inspection for Taloja Bioequivalence Center Ruchika Sharma30 July 2021 11:00 AM ISTMumbai: Alkem Laboratories Ltd. has recently announced the successful completion of U.S Food and Drug Administration (USFDA) inspection of its...
JnJ single-shot COVID vaccine shelf life extended by USFDA to 6 months Ruchika Sharma29 July 2021 2:22 PM ISTNew Delhi: The U.S. Food & Drug Administration extended the shelf life for Johnson & Johnson's single-shot COVID-19 vaccine to six months...
Biocon Biologics, Viatris get USFDA nod for first interchangeable biosimilar Semglee for diabetes Ruchika Sharma29 July 2021 1:33 PM ISTThe interchangeable Semglee product, which will allow substitution of Semglee for the reference product, Lantus, at the pharmacy counter, will be...
Despite import alert for India plant, Jubilant Pharma rating headroom healthy: Fitch Ruchika Sharma27 July 2021 3:22 PM ISTSingapore: Jubilant Pharma Ltd (JPL) will continue to maintain good rating headroom as the impact of a recent US Food and Drug Administration import...
Sun Pharma, Cassiopea SpA ink pact for acne treatment drug Winlevi in US, Canada Ruchika Sharma26 July 2021 2:00 PM ISTMumbai: Sun Pharmaceutical Industries Ltd. and Cassiopea SpA today announced the signing of License and Supply Agreements for Winlevi (clascoterone...
Cipla recalls Solifenacin Succinate tablets in US over manufacturing issues Ruchika Sharma26 July 2021 1:30 PM ISTNew Delhi: Drug major Cipla is recalling 7,228 bottles of Solifenacin Succinate tablets, a medicine used to treat overactive bladder, in the US market...
Philips ventilator recall classified as most serious by USFDA Ruchika Sharma23 July 2021 3:58 PM ISTNew Delhi: The U.S. Food and Drug Administration on Thursday classified the recall of Philips' breathing devices and ventilators as Class 1, or...
Granules India arm clears USFDA audit Ruchika Sharma22 July 2021 12:03 PM ISTHyderabad: Granules India Limited has announced that Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company located...
Zydus Cadila gets USFDA nod for cancer drug Ibrutinib Ruchika Sharma21 July 2021 3:36 PM ISTAhmedabad: Drugmaker, Zydus Cadila, today announced that the company has received tentative approval from the United States Food & Drug...
Biogen Alzheimer's drug: Former FDA adviser calls for wider probe into approval Ruchika Sharma21 July 2021 2:00 PM ISTNew Delhi: A federal probe of the U.S. Food and Drug Administration's approval of a controversial new Alzheimer's disease drug should look into why...
Merck gets USFDA nod for Pneumococcal 15-valent Conjugate Vaccine Ruchika Sharma18 July 2021 10:30 AM ISTKenilworth: Merck known as MSD outside the United States and Canada, has recently announced the U.S. Food and Drug Administration (USFDA) approved...
Pfizer-BioNTech COVID vaccine to be reviewed by USFDA by January Ruchika Sharma18 July 2021 10:00 AM ISTNew Delhi: The U.S. health regulator will review Pfizer and German partner BioNTech SE's application for full approval of their COVID-19...
