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Tag: usfda

You Searched For "usfda"
Biocon Biologics Yesafili gets Health Canada nod for eye diseases

Biocon Biologics arm gets OAI status from USFDA for Malaysia insulin facility

Ruchika Sharma18 Oct 2023 12:30 PM IST
Bengaluru: Biocon Sdn Bhd., a step-down subsidiary of Biocon Biologics Limited has received a communication from the U.S. Food and Drug...
Health Bulletin 17/October/2023

Health Bulletin 17/October/2023

Roshni Dhar17 Oct 2023 5:07 PM IST
Here are the top health stories for the day:MCC warns NEET PG, MDS candidates against fake admission form circulating on social mediaThrough a recent...
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 gets USFDA nod for neoadjuvant/ adjuvant Keytruda for resectable non-small cell lung cancer

Ruchika Sharma17 Oct 2023 12:54 PM IST
The approval marks the sixth NSCLC indication for KEYTRUDA.
Pfizer Told To Conduct Phase IV Trial of Abrocitinib in Indian Adolescents with Atopic Dermatitis

USFDA approves Pfizer Velsipity for adults with Ulcerative Colitis

Ruchika Sharma14 Oct 2023 2:30 PM IST
New York: Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved VELSIPITY (etrasimod), an oral, once-daily,...
Lupin bags tentative USFDA nod for Loteprednol Etabonate Ophthalmic Gel

Lupin bags tentative USFDA nod for generic equivalent of Janssen Biotech Erleada Tablets

Ruchika Sharma14 Oct 2023 1:00 PM IST
Mumbai: Global pharma major Lupin Limited has announced that the Company has received tentative approval from the United States Food and Drug...
Zydus Lifesciences unit recalls over 7000 bottles of overactive bladder drug Oxybutynin Chloride in US

Zydus Lifesciences unit recalls over 7000 bottles of overactive bladder drug Oxybutynin Chloride in US

Ruchika Sharma14 Oct 2023 11:44 AM IST
The lot was produced at Ahmedabad and distributed in the US by Zydus Pharmaceuticals (USA) Inc, the US health regulator stated.
Caplin Steriles gets USFDA nod for Procainamide Hydrochloride Injection for treating abnormal heart rhythm

Pfizer gets USFDA nod for Braftovi plus Mektovi for BRAF V600E-Mutant Metastatic Non-Small Cell Lung Cancer

Ruchika Sharma14 Oct 2023 10:30 AM IST
New York: Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI (encorafenib) + MEKTOVI (binimetinib)...
Lupin partners with Sandoz to market, commercialize Ranibizumab biosimilar across multiple regions

Lupin gets tentative USFDA nod for generic equivalent of Xywav Oral Solution

Ruchika Sharma13 Oct 2023 12:38 PM IST
Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch.
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

Panacea Biotec Pharma Baddi facility gets 9 USFDA observations

Ruchika Sharma13 Oct 2023 11:30 AM IST
Punjab: Panacea Biotec Limited has announced that the Company’s material wholly-owned subsidiary, Panacea Biotec Pharma Limited...
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe

USFDA issues 9 observations for Dr Reddy's Labs Hyderabad facility

Ruchika Sharma13 Oct 2023 10:30 AM IST
Hyderabad: Pharma major, Dr Reddy's Labs, has announced that the United States Food & Drug Administration (USFDA) has concluded a product...
Cipla arm New York facility gets EIR from USFDA

Cipla arm New York facility gets EIR from USFDA

Ruchika Sharma12 Oct 2023 3:30 PM IST
Mumbai: Cipla has announced that the New York manufacturing facility of InvaGen Pharmaceuticals Inc., a wholly-owned subsidiary of the Company,...
Novartis oral Fabhalta gets USFDA nod for adults with C3 glomerulopathy

Novartis Cosentyx IV formulation for rheumatic diseases bags USFDA okay

Ruchika Sharma10 Oct 2023 1:30 PM IST
The IV formulation of Cosentyx offers patients a monthly 30-minute, weight-based dosing option, requiring no pre-medication and no lab monitoring.
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