Zydus Lifesciences arm secures USFDA nod for tardive dyskinesia drug Valbenazine Ruchika Sharma17 Oct 2022 12:30 PM ISTAhmedabad: Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) subsidiary Zydus Worldwide DMCC has received tentative approval...
Unichem Labs bags USFDA nod for Extended Phenytoin Sodium Capsules Ruchika Sharma14 Oct 2022 3:30 PM ISTMumbai: Unichem Laboratories Limited has announced that the company has received abbreviated new drug application (ANDA) approval for its...
Gilead Sciences Trodelvy under USFDA priority review for adult patients with pretreated metastatic breast cancer Ruchika Sharma14 Oct 2022 2:30 PM ISTTrodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate.
Pfizer gets USFDA Emergency Use Authorization for bivalent omicron booster in children aged 5 through 11 years Ruchika Sharma13 Oct 2022 4:00 PM ISTNew York: Pfizer Inc. and BioNTech SE have announced that the U.S. Food and Drug Administration (USFDA) has granted Emergency Use Authorization...
USFDA warns of Teva Pharma ADHD drug Adderall shortage Ruchika Sharma13 Oct 2022 1:30 PM ISTAdderall is an FDA-approved prescription drug made of two stimulants amphetamine and dextroamphetamine.
Sanofi, Provention Bio ink pact for launch of Diabetes drug Teplizumab Ruchika Sharma9 Oct 2022 4:00 PM ISTTeplizumab is an anti-CD3 monoclonal antibody that is being developed for the delay of clinical T1D in at-risk individuals, as indicated by the...
USFDA expands use of GSK Boostrix vaccine during pregnancy to prevent whooping cough in infants Ruchika Sharma8 Oct 2022 11:16 AM ISTUS: The U.S. Food and Drug Administration (USFDA) has allowed the use of GlaxoSmithKline's Boostrix vaccine during the third trimester of...
Eli Lilly gets USFDA Fast Track designation for Tirzepatide to treat adults with obesity Ruchika Sharma7 Oct 2022 12:15 PM ISTTirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist.
Zydus Amantadine ER Capsules gets USFDA okay Ruchika Sharma6 Oct 2022 2:00 PM ISTThe drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Unichem Pharma recalls over 18000 bottles of Clonidine Hydrochloride tablets in US Ruchika Sharma6 Oct 2022 12:00 PM ISTThe affected lot of tables have been manufactured by Unichem Laboratories in its Goa-based plant and distributed in the US market by New Jersey-based...
Zydus Lifesciences US arm bags USFDA nod for Brivaracetam Tablets to treat partial-onset seizures Ruchika Sharma6 Oct 2022 11:17 AM ISTBrivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
USFDA approves Kite retroviral vector manufacturing facility in Southern California for commercial production Ruchika Sharma5 Oct 2022 12:52 PM ISTThe Oceanside site is part of Kite’s global commercial manufacturing network that includes facilities in El Segundo, California, Amsterdam,...
