Moderna seeks USFDA nod for COVID booster tailored against Omicron subvariants Ruchika Sharma24 Aug 2022 1:15 PM ISTThe submission also includes clinical trial data for its BA.1 Omicron-targeting bivalent booster candidate, which was last week cleared in Britain.
Aurobindo Pharma arm bags USFDA nod for Medroxyprogesterone Acetate Injectable Suspension Ruchika Sharma24 Aug 2022 12:25 PM ISTHyderabad: Drugmaker, Aurobindo Pharma Limited, today announced that its wholly-owned subsidiary company, Eugia Pharma Specialties Limited, has...
Merck Investigational Anticoagulant Therapy MK-2060 gets USFDA fast track designation Ruchika Sharma24 Aug 2022 11:27 AM ISTMK-2060 is a novel inhibitor of Factor XI being investigated for the prevention of thrombosis in patients with end-stage renal disease (ESRD).
Unichem Labs anticonvulsant drug Carbamazepine gets USFDA okay Ruchika Sharma23 Aug 2022 12:32 PM ISTCarbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia.
Pfizer, BioNTech seek USFDA emergency use nod for Omicron adapted COVID booster dose for 12 years of age and older Ruchika Sharma23 Aug 2022 11:32 AM ISTThe bivalent vaccine contains mRNA encoding the original SARS-CoV-2 spike protein, which is present in the original Pfizer-BioNTech COVID-19 Vaccine,...
Cognota Healthcare secures USFDA nod for blood pressure monitor device Ruchika Sharma22 Aug 2022 2:31 PM ISTPune: Healthtech company Cognota Healthcare has announced that the United States Food and Drug Administration (US FDA) has approved the company's...
Novavax COVID vaccine Nuvaxovid gets provisional nod in New Zealand for adolescents aged 12 through 17 Ruchika Sharma22 Aug 2022 1:45 PM ISTNuvaxovid (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes...
Novavax COVID vaccine Adjuvanted gets USFDA emergency use authorization for adolescents aged 12 through 17 Ruchika Sharma22 Aug 2022 12:15 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.
Cipla, Glenmark and 1 other recall products in US over manufacturing issues Ruchika Sharma22 Aug 2022 11:23 AM ISTAs per the USFDA, homegrown drug major Cipla is recalling 7,992 bottles of Difluprednate Ophthalmic Emulsion, used to treat swelling and pain after...
Bayer Mirena gets USFDA nod for extended use as contraceptive Ruchika Sharma21 Aug 2022 1:15 PM ISTLNG-IUS is one of the most effective birth control methods as it does not require user interventions such as daily dosing or monthly re-fills.
Test second Paxlovid course in patients with COVID rebound: USFDA asks Pfizer Ruchika Sharma21 Aug 2022 11:30 AM ISTBengaluru: The U.S. Food and Drug Administration (USFDA) has asked Pfizer Inc to test the effects of an additional course of its antiviral Paxlovid...
Axsome Therapeutics gets USFDA nod for AUVELITY to treat Major Depressive Disorder in adults Ruchika Sharma20 Aug 2022 5:48 PM ISTNew York: Axsome Therapeutics, Inc., a biopharmaceutical company developing and delivering novel therapies for the management of central nervous...
