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Results For "USFDA"

1355 News Found

Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili
Drug Approval | May 21, 2024

Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili

The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States


Moderna update on investigational RSV vaccine
Drug Approval | May 14, 2024

Moderna update on investigational RSV vaccine

U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024


Briefs: Lupin and Aurobindo Pharma
News | May 13, 2024

Briefs: Lupin and Aurobindo Pharma

Lupin updates on shipment of Mirabegron ER Tablets


Gland Pharma receives approval for Edaravone Injection
Drug Approval | May 09, 2024

Gland Pharma receives approval for Edaravone Injection

The product is used to treat amyotrophic lateral sclerosis


Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals
Drug Approval | May 06, 2024

Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals

Eugia Pharma Specialities receives 7 observations from USFDA for Unit II


Dr. Reddy's Laboratories launches Doxycycline Capsules, 40 mg in US
Drug Approval | May 06, 2024

Dr. Reddy's Laboratories launches Doxycycline Capsules, 40 mg in US

ORACEA is a trademark of Galderma Holdings, S.A.


FDA grants full approval for TIVDAK to treat cervical cancer
Drug Approval | May 02, 2024

FDA grants full approval for TIVDAK to treat cervical cancer

TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer


Gland Pharma appoints Satnam Singh Loomba as COO
People | April 29, 2024

Gland Pharma appoints Satnam Singh Loomba as COO

Before joining Gland, Loomba was associated with Shalina Labs, Harman Finochem, Aurobindo Pharma, Sun Pharmaceuticals and Ranabaxy Laboratories.


Glenmark receives ANDA approval for acetaminophen and ibuprofen tablets
Drug Approval | April 29, 2024

Glenmark receives ANDA approval for acetaminophen and ibuprofen tablets

Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA