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Tag: usfda

You Searched For "usfda"
Zydus gets USFDA nod to Pimavanserin for Parkinsons disease-linked psychosis

Zydus gets USFDA nod to Pimavanserin for Parkinson's disease-linked psychosis

Ruchika Sharma23 Dec 2021 11:55 AM IST
Ahmedabad: Drugmaker, Zydus Cadila has received tentative approval from the US Food and drug Administration (USFDA) to market Pimavanserin Tablets,...
MSN Pharma concludes USFDA audit with zero observations

MSN Pharma concludes USFDA audit with zero observations

Ruchika Sharma22 Dec 2021 12:09 PM IST
Hyderabad: MSN Pharmaceuticals Inc. (MSNPI), a wholly-owned subsidiary of MSN Group of Companies, based out of Piscataway, New Jersey, USA has...
Takeda receives USFDA Complete Response Letter for Budesonide Oral Suspension

Takeda receives USFDA Complete Response Letter for Budesonide Oral Suspension

Ruchika Sharma22 Dec 2021 11:30 AM IST
Osaka: Takeda Pharmaceutical Company Limited has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug...
USFDA to authorize Pfizer, Merck COVID pills this week: Report

USFDA to authorize Pfizer, Merck COVID pills this week: Report

Ruchika Sharma22 Dec 2021 10:00 AM IST
New Delhi: The U.S. Food and Drug Administration is set to authorize COVID-19 treatment pills from both Pfizer Inc and Merck as early as December...
Expanded use of Amgen psoriasis drug Otezla gets USFDA okay

Expanded use of Amgen psoriasis drug Otezla gets USFDA okay

Ruchika Sharma21 Dec 2021 11:00 AM IST
Thousand Oaks: Amgen has recently announced that the U.S. Food and Drug Administration (FDA) has approved Otezla (apremilast) for the...
Cipla bags USFDA nod for Lanreotide Injection

Cipla bags USFDA nod for Lanreotide Injection

Ruchika Sharma20 Dec 2021 12:54 PM IST
Mumbai: Cipla Limited along with its subsidiary Cipla USA, Inc., announced that it has received final approval for its Lanreotide Injection, from the...
Pfizer, BioNTech seek USFDA approval for COMIRNATY in adolescents aged 12-15 years

Pfizer, BioNTech seek USFDA approval for COMIRNATY in adolescents aged 12-15 years

Ruchika Sharma18 Dec 2021 3:35 PM IST
New York: Pfizer Inc. and BioNTech SE have announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug...
Torrent pharma successfully completes USFDA inspection for Levittown facility

Torrent pharma successfully completes USFDA inspection for Levittown facility

Ruchika Sharma17 Dec 2021 4:28 PM IST
Ahmedabad: Torrent Pharma has recently announced that the US Food and Drug Administration (USFDA) has successfully concluded inspection at...
MSN Labs gets USFDA nod for generic version of Cangrelor in India

MSN Labs gets USFDA nod for generic version of Cangrelor in India

Ruchika Sharma17 Dec 2021 1:02 PM IST
Hyderabad: Close on the heels of securing Drug Controller General of India's approval for CANREAL injection (generic version of Cangrelor) in India,...
Sun Pharma

Sun Pharma gets USFDA nod for Generic Amphotericin B Liposome Injection

Ruchika Sharma17 Dec 2021 11:09 AM IST
Mumbai: Sun Pharmaceutical Industries Limited has announced that one of its wholly-owned subsidiaries has received final approval from United States...
Zydus Cadila novel compound to treat malaria ZY-19489 gets Orphan Drug Designation from USFDA

Zydus Cadila novel compound to treat malaria ZY-19489 gets Orphan Drug Designation from USFDA

Ruchika Sharma16 Dec 2021 3:25 PM IST
Ahmedabad: Zydus Cadila, a research-driven, global healthcare provider, today announced that its antimalarial compound ZY19489 (MMV253),...
Pfizer Xeljanz secures USFDA nod to treat active ankylosing spondylitis

Pfizer Xeljanz secures USFDA nod to treat active ankylosing spondylitis

Ruchika Sharma15 Dec 2021 3:20 PM IST
New York: Pfizer Inc. has announced that the U.S. Food and Drug Administration (USFDA) has approved the supplemental New Drug Application (sNDA) for...
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