Natco Pharma marketing partner gets USFDA nod for Carfilzomib Vials ANDA Ruchika Sharma15 Jun 2021 12:00 PM ISTHyderabad: Drugmaker, Natco Pharma Limited, has recently announced that the company's marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has...
Avenue Therapeutics gets USFDA Complete Response Letter for IV Tramadol Ruchika Sharma15 Jun 2021 10:00 AM ISTAvenue disagrees with the FDA's interpretation of the data in the NDA and intends to continue to pursue regulatory approval for IV tramadol.
Lupin New Jersey facility gets USFDA warning letter Ruchika Sharma14 Jun 2021 11:55 AM ISTMumbai: Drug major, Lupin, has recently announced that the company has received a warning letter from the USFDA for its Somerset, New Jersey facility....
Zydus Cadila epilepsy drug Brivaracetam secures USFDA nod Ruchika Sharma14 Jun 2021 11:19 AM ISTAhmedabad: Drugmaker, Zydus Cadila, today announced that the company has received tentative approval from the United States Food & Drug...
Setback: Bharat Biotech Covaxin denied emergency use authorization in US Ruchika Sharma12 Jun 2021 11:45 AM ISTNew Delhi: In a setback to Bharat Biotech's COVID-19 vaccine Covaxin, the US Food and Drug Administration has "recommended" Ocugen Inc, the US partner...
Biogen, Eisai secure USFDA accelerated nod for Alzheimer drug ADUHELM Ruchika Sharma8 Jun 2021 3:57 PM ISTCambridge: Biogen and Eisai, Co., Ltd. have announced that the U.S. Food and Drug Administration (USFDA) has granted accelerated...
Lupin bags USFDA nod for Emtricitabine, Tenofovir Disoproxil Fumarate Tablets to treat HIV Ruchika Sharma8 Jun 2021 11:29 AM ISTEmtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg, are indicated in combination with other antiretroviral agents for the...
Glenmark Theophylline ER Tablets gets USFDA approval Ruchika Sharma5 Jun 2021 12:30 PM ISTMumbai: Drugmaker, Glenmark Pharmaceuticals Limited, has recently announced that the company has received final approval by the United States Food...
Lupin application for Pegfilgrastim biosimilar accepted by USFDA Ruchika Sharma3 Jun 2021 12:13 PM ISTMumbai: Global pharma major, Lupin Limited, has recently announced that the USFDA has accepted the Biologics License Application (BLA) for its...
DCGI exempts foreign-made COVID vaccines from post-approval bridging trials Medical Dialogues Team2 Jun 2021 4:29 PM ISTNew Delhi: Through a recent notification, the Central Drugs Standards Control Organization (CDSCO), led by the Drugs Controller General of India...
Zydus Cadila gets USFDA nod to Fluphenazine Hydrochloride Tablets Ruchika Sharma30 May 2021 9:30 AM ISTAhmedabad: Drugmaker, Zydus Cadila, has recently announced that the company has received final approval from the USFDA to market Fluphenazine...
Bharat Biotech American partner submits Covaxin Master File to USFDA Ruchika Sharma26 May 2021 11:37 AM ISTIn an investor presentation, Ocugen said it is expecting the vaccine to be rolled out in the US during the second half of the current year.
