Abbott gets USFDA breakthrough device designation for deep brain stimulation system in depression Ruchika Sharma14 July 2022 5:27 PM ISTAbbott's DBS system is a personalized, adjustable therapy that involves implanting thin wires – or leads – into targeted areas of the brain.
USFDA removes Jubilant Generics' Olanzapine, Spironolactone and Valsartan from list of excepted products from import Ruchika Sharma14 July 2022 4:09 PM ISTPost this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.
Novavax COVID vaccine gets USFDA emergency use nod for 18 years and older Ruchika Sharma14 July 2022 12:14 PM ISTNVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
USFDA mulls to approve first-ever OTC birth control pill MD Bureau13 July 2022 12:30 PM IST"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the US," said Frederique Welgryn, Chief...
Zydus Lifesciences bags USFDA approval for Empagliflozin, Metformin Hydrochloride Tablets Ruchika Sharma11 July 2022 12:23 PM ISTThe drug will be manufactured at the group’s formulation facility at SEZ, Ahmedabad, India.
Intercept to go back to USFDA with its NASH treatment application Ruchika Sharma10 July 2022 9:30 AM ISTNew Jersey: Intercept Pharmaceuticals Inc will resubmit its application for approval of its therapy for a chronic liver disease to the U.S. Food and...
Lupin Somerset facility gets EIR from USFDA Rahul Verma9 July 2022 6:30 PM ISTGlobal pharma major, Lupin Limited, today announced that the company has received the Establishment Inspection Report (EIR) from United States Food...
Dr Reddy's Labs launches Fesoterodine Fumarate Extended-Release Tablets in US Ruchika Sharma9 July 2022 2:55 PM ISTHyderabad: Drugmaker, Dr. Reddy's Laboratories Ltd., has announced the launch of the company's Fesoterodine Fumarate Extended-Release Tablets, a...
Pfizer-BioNTech gets USFDA nod for COVID vaccine Comirnaty for adolescents 12 through 15 years of age Ruchika Sharma9 July 2022 1:45 PM ISTCOMIRNATY (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute...
Roche gets USFDA priority review for Lunsumio to treat relapsed or refractory follicular lymphoma Ruchika Sharma8 July 2022 5:30 PM ISTPriority Review designation is granted to medicines that the FDA considers to have the potential to provide significant improvements in the safety and...
USFDA authorizes pharmacists to prescribe Pfizer COVID drug Paxlovid Ruchika Sharma8 July 2022 2:30 PM ISTThe agency said patients who tested positive for COVID-19 should bring their health records for the pharmacists to review for kidney and liver...
Alkem Labs gets 1 observation from USFDA for Indore facility Ruchika Sharma8 July 2022 1:30 PM ISTNew Delhi: Alkem Laboratories Limited has recently announced that the United States Food and Drug Administration (USFDA) has issued Form 483 with...
