Pfizer gets expanded USFDA emergency use nod for additional COVID Vaccine booster in adults aged 50 years and older Ruchika Sharma30 March 2022 12:25 PM ISTThe additional booster is to be administered at least four months after the first booster and is the same formulation and strength as prior...
Novo Nordisk gets USFDA nod for Ozempic 2 mg to treat type 2 diabetes Ruchika Sharma29 March 2022 12:23 PM ISTPlainsboro: Novo Nordisk has recently announced that the US Food and Drug Administration (USFDA) has approved a 2 mg dose of Ozempic (semaglutide)...
USFDA amends emergency use authorization for Sotrovimab due to Omicron BA.2 Subvariant Ruchika Sharma27 March 2022 10:15 AM ISTSan Francisco: GlaxoSmithKline plc and Vir Biotechnology, Inc. have announced that the US Food and Drug Administration (USFDA) has amended...
Novartis gets USFDA nod for Pluvicto to treat prostate cancer Ruchika Sharma27 March 2022 10:00 AM ISTBasel: Novartis has recently announced that the US Food and Drug Administration (USFDA) has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan)...
Setback: Eli Lilly- Innovent lung cancer drug Sintilimab rejected by USFDA Ruchika Sharma26 March 2022 12:41 PM ISTFDA and its advisers had raised concerns over the lack of population diversity in a single-country trial.
Pfizer gets USFDA Breakthrough Therapy Designation for RSV Vaccine Ruchika Sharma26 March 2022 9:45 AM ISTNew York: Pfizer Inc. has announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, has received...
Presence of harmful bacteria at Similac production facility: USFDA probe Ruchika Sharma25 March 2022 4:11 PM ISTNo Cronobacter sakazakii was found during the company's testing of products that were distributed to the consumers, Abbott added.
Lupin bags USFDA nod for Sildenafil for Oral Suspension Ruchika Sharma25 March 2022 11:49 AM ISTSildenafil is a medication used to treat erectile dysfunction and pulmonary arterial hypertension.
Alembic Pharmaceuticals receives USFDA nod for Lacosamide Tablets MD Bureau23 March 2022 6:51 PM ISTLacosamide Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, have an estimated market size of US dollar 1.67 billion for twelve months ending December 2021...
Indoco Remedies receives USFDA nod for Lacosamide Tablets MD Bureau23 March 2022 5:41 PM ISTLacosamide Tablets are indicated for the prevention and control of seizures. It is an anticonvulsant/antiepileptic drug.
Zydus gets USFDA Prior Approval Supplement (PAS) approval for Mycophenolate Mofetil for Injection USP MD Bureau21 March 2022 4:41 PM ISTThe injection will be manufactured at the groups injectables manufacturing facility at Jarod near Vadodara in Gujarat.
Bristol Myers gets USFDA approval for First LAG-3-Blocking Antibody Combination, Opduala MD Bureau20 March 2022 2:30 PM ISTThe trial met its primary endpoint, progression-free survival, and Opdualag more than doubled the median PFS when compared to nivolumab monotherapy,...
