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Tag: usfda

You Searched For "usfda"
Pfizer discontinues development of danuglipron for chronic weight management

USFDA approves Pfizer CIBINQO for adolscents with refractory atopic dermatitis

Ruchika Sharma12 Feb 2023 1:00 PM IST
CIBINQO is an oral inhibitor of Janus kinase (JAK) 1.
Sun Pharma recalls over 34000 bottles of generic medication in US due to failed dissolution testing

Sun Pharma recalls over 34000 bottles of generic medication in US due to failed dissolution testing

Ruchika Sharma11 Feb 2023 2:35 PM IST
New Delhi: Drug major Sun Pharma is recalling over 34,000 bottles of a generic medication, used to treat high blood pressure, in the US market due to...
Lupin receives USFDA observations for two Pithampur manufacturing Units

Laurus Labs gets 2 USFDA observations for Visakhapatnam facility

Ruchika Sharma11 Feb 2023 1:15 PM IST
Telangana: Laurus Labs has announced that the company has received Form 483 with two observations from the US Food and Drug Administration (USFDA)...
Sun Pharma bags USFDA okay for generic lenalidomide capsules

Sun Pharma bags USFDA okay for generic lenalidomide capsules

Ruchika Sharma11 Feb 2023 12:30 PM IST
Mumbai: Pharma major, Sun Pharmaceutical Industries Limited, has announced that one of its wholly owned subsidiaries has received final approval from...
GSK gets full USFDA nod for Jemperli to treat recurrent or advanced mismatch repair deficient endometrial cancer

GSK gets full USFDA nod for Jemperli to treat recurrent or advanced mismatch repair deficient endometrial cancer

Ruchika Sharma11 Feb 2023 11:30 AM IST
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands...
USFDA nod to Lupin Glycopyrrolate Injection

USFDA nod to Lupin Glycopyrrolate Injection

Ruchika Sharma9 Feb 2023 12:05 PM IST
Mumbai: Global pharma major Lupin Limited today announced that the company has received approval from the United States Food and Drug Administration...
Aurobindo Pharma restarts production at Kakinada Penicillin-G plant after fire incident

Aurobindo Pharma subsidiary bags USFDA nod to manufacture, market Diclofenac Sodium Topical Solution

Ruchika Sharma8 Feb 2023 11:15 AM IST
Diclofenac Sodium Topical Solution USP, 2 % w/w is indicated for the treatment of the pain of osteoarthritis of the knee(s).
Manufacturing of eye drops linked to 55 adverse events in US suspended by CDSCO

Manufacturing of eye drops linked to 55 adverse events in US suspended by CDSCO

Roshni Dhar7 Feb 2023 6:00 PM IST
The Central Drugs Standard Control Organisation (CDSCO) has suspended the manufacturing of eye drops and initiated its probe after the United States'...
Health Bulletin 7/February/2023

Health Bulletin 7/February/2023

Isra Zaman7 Feb 2023 4:34 PM IST
Here are the top health stories for the day:NEET: Supreme Court declares center's order of barring OCI candidates from general seats to be applied...
Biogen, Sage Therapeutics get USFDA priority review for depression drug Zuranolone

Biogen, Sage Therapeutics get USFDA priority review for depression drug Zuranolone

Ruchika Sharma7 Feb 2023 1:15 PM IST
Zuranolone is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM).
USFDA accepts Biologics License Application for proposed biosimilar denosumab: Sandoz

USFDA accepts Biologics License Application for proposed biosimilar denosumab: Sandoz

Ruchika Sharma7 Feb 2023 10:15 AM IST
Denosumab is a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone...
CDSCO suspends manufacturing of eye drops linked to 55 adverse events in US

CDSCO suspends manufacturing of eye drops linked to 55 adverse events in US

Ruchika Sharma6 Feb 2023 2:15 PM IST
FDA also placed Global Pharma Healthcare Private Limited on import alert for providing an inadequate response to a records request and for not...
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