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Tag: usfda

You Searched For "usfda"
USFDA issues warning letter to Emergent BioSolutions Baltimore facility

USFDA issues warning letter to Emergent BioSolutions Baltimore facility

Ruchika Sharma15 Aug 2022 2:15 PM IST
New Delhi: Emergent BioSolutions Inc said on Friday it had received a warning letter from the U.S. Food and Drug Administration, citing certain...
Thermo Fisher Scientific secures USFDA nod for Oncomine Dx Target Test for lung cancers with HER2 mutations

Thermo Fisher Scientific secures USFDA nod for Oncomine Dx Target Test for lung cancers with HER2 mutations

Ruchika Sharma15 Aug 2022 12:00 PM IST
The Oncomine Dx Target Test is designed to simultaneously evaluate 23 genes associated with NSCLC.
USFDA says possible carcinogens found in Mercks Sitagliptin drugs Januvia, Janumet

USFDA says possible carcinogens found in Merck's Sitagliptin drugs Januvia, Janumet

Roshni Dhar13 Aug 2022 5:39 PM IST
The U.S. Food and Drug Administration said on Tuesday certain samples of sitagliptin, a compound in Merck's diabetes drugs Januvia and Janumet, were...
Lupin bags USFDA nod for Meclizine Hydrochloride Tablets

Lupin bags USFDA nod for Meclizine Hydrochloride Tablets

Ruchika Sharma13 Aug 2022 1:00 PM IST
The product is a generic equivalent of Antivert Tablets, 12.5 mg, 25 mg, and 50 mg, of Casper Pharma LLC.
FDA, EMA found no evidence of causal association between ranitidine and cancer: GSK issues statement

FDA, EMA found no evidence of causal association between ranitidine and cancer: GSK issues statement

Ruchika Sharma13 Aug 2022 12:20 PM IST
New Delhi: In response to recent speculative commentary regarding U.S. Zantac litigation, GSK plc has issued the following statement regarding Zantac...
Health Bulletin 12/August/2022

Health Bulletin 12/August/2022

Roshni Dhar12 Aug 2022 5:33 PM IST
Here are the Top Health stories for the day:Omicron is not mild for the frail, 32 deaths in Delhi in 10 daysThere have been 32 deaths in the past 10...
Zydus bags USFDA nod for Prochlorperazine Maleate Tablets

Zydus bags USFDA nod for Prochlorperazine Maleate Tablets

Ruchika Sharma11 Aug 2022 11:01 AM IST
The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Possible carcinogens found in Mercks Sitagliptin drugs Januvia, Janumet: USFDA

Possible carcinogens found in Merck's Sitagliptin drugs Januvia, Janumet: USFDA

Ruchika Sharma10 Aug 2022 5:08 PM IST
New Delhi: The U.S. Food and Drug Administration said on Tuesday certain samples of sitagliptin, a compound in Merck's diabetes drugs Januvia and...
Bayer begins Phase I study with GIRK4 inhibitor for atrial fibrillation

Bayer gets USFDA nod for Darolutamide, Docetaxel combo to treat metastatic hormone-sensitive prostate cancer

Ruchika Sharma10 Aug 2022 3:00 PM IST
Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
Strides successfully concludes USFDA inspection at Singapore facility

Strides successfully concludes USFDA inspection at Singapore facility

Ruchika Sharma10 Aug 2022 11:00 AM IST
Bengaluru: Strides Pharma Science Limited has announced that its formulation facility at Singapore underwent a US Food and Drug Administration...
Unichem Labs bags USFDA nod for Labetalol Hydrochloride Tablets

Unichem Labs bags USFDA nod for Labetalol Hydrochloride Tablets

Ruchika Sharma10 Aug 2022 10:00 AM IST
Mumbai: Drugmaker, Unichem Laboratories Limited, has recently announced that the company has received Abbreviated New Drug Application...
Alembic Pharma subsidiary bags USFDA nod for Adapalene, Benzoyl peroxide topical gel

Alembic Pharma subsidiary bags USFDA nod for Adapalene, Benzoyl peroxide topical gel

Ruchika Sharma8 Aug 2022 2:37 PM IST
The gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older, the company said
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