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Tag: usfda

You Searched For "usfda"
Lupin partners with Sandoz to market, commercialize Ranibizumab biosimilar across multiple regions

Lupin secures tentative USFDA nod for Selexipag for Injection

Ruchika Sharma2 Nov 2023 4:30 PM IST
This product will be manufactured at Lupin's Nagpur facility in India.
Merck gets USFDA Priority Review for application for Keytruda plus standard of care as Perioperative treatment for Resectable Locally Advanced Head, Neck Squamous Cell Carcinoma

Merck bags USFDA nod for Keytruda plus gemcitabine, cisplatin to treat Biliary Tract Cancer

Ruchika Sharma2 Nov 2023 2:30 PM IST
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and...
Natco Pharma Pharmacovigilance department successfully completes USFDA inspection

Natco Pharma Pharmacovigilance department successfully completes USFDA inspection

Ruchika Sharma2 Nov 2023 1:00 PM IST
Hyderabad: Natco Pharma Limited has announced the successful completion of United States Food and Drug Administration’s (USFDA) inspection of the...
Pfizer hair loss drug Litfulo approved in UK

Pfizer hair loss drug Litfulo approved in UK

Ruchika Sharma2 Nov 2023 11:30 AM IST
Alopecia areata is a condition where the immune system attacks hair follicles and causes hair to fall out, often in clumps.
Novartis wins USFDA nod for Cosentyx to treat hidradenitis suppurativa in adults

Novartis wins USFDA nod for Cosentyx to treat hidradenitis suppurativa in adults

Ruchika Sharma1 Nov 2023 2:00 PM IST
Basel: Novartis has announced that the US Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) to treat moderate to severe...
Senores Pharma arm facility gets 3 USFDA observations

USFDA issues EIR for Ipca Labs SEZ Indore facility

Ruchika Sharma31 Oct 2023 1:30 PM IST
Mumbai: Ipca Labs has announced that the United States of Food and Drug Administration (USFDA) has issued Establishment Inspection Report (EIR)...
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

Dr Reddy's Labs gets 10 USFDA observations for Bachupally facility

Ruchika Sharma30 Oct 2023 1:30 PM IST
Hyderabad: Dr Reddy's Labs has recently announced that the United States Food & Drug Administration (USFDA) has competed an inspection with ten...
USFDA warns against use of 26 over-the-counter eye drop products

USFDA warns against use of 26 over-the-counter eye drop products

Ruchika Sharma29 Oct 2023 11:30 AM IST
Bengaluru: The U S. Food and Drug Administration has issued a warning to consumers to not purchase or use certain eye drops from several major brands...
USFDA approves Abbott Tendyne to replace mitral valve without open-heart surgery

After USFDA warning, Abbott Labs to stop sales of Similac Probiotic Tri-Blend product

Ruchika Sharma28 Oct 2023 1:30 PM IST
"The product is an unapproved new drug and an unlicensed biological product being sold in violation" of regulations, the FDA said about Abbott's...
Eli Lilly Omvoh gets USFDA okay for Ulcerative Colitis in adults

Eli Lilly Omvoh gets USFDA okay for Ulcerative Colitis in adults

Ruchika Sharma27 Oct 2023 12:19 PM IST
Omvoh will be available in the United States in the coming weeks.
No Waiver for Faricimab: CDSCO Panel Asks Roche to Conduct Phase III Trial in India

Roche bags USFDA nod for Vabysmo to treat retinal vein occlusion

Ruchika Sharma27 Oct 2023 11:32 AM IST
"Vabysmo is a new treatment option for RVO that can help people preserve and improve their vision, with the added benefit of retinal drying," said...
No observations: USFDA inspection at Cipla arm InvaGen New York plant concludes

No observations: USFDA inspection at Cipla arm InvaGen New York plant concludes

Ruchika Sharma27 Oct 2023 7:30 AM IST
Mumbai: Drugmaker Cipla has announced that the United States Food and Drug Administration (USFDA) has concluded inspection with zero Form 483...
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