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Results For "Food-and-Drug-Administration"

1255 News Found

Cipla receives final approval for the generic version of Somatuline Depot Injection
Drug Approval | May 23, 2024

Cipla receives final approval for the generic version of Somatuline Depot Injection

Cipla's Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline Depot (Lanreotide) Injection


Indica Labs receives FDA clearance for HALO AP Dx digital pathology platform
Digitisation | May 23, 2024

Indica Labs receives FDA clearance for HALO AP Dx digital pathology platform

For use with Hamamatsu Images acquired with the NanoZoomer S360MD slide scanner


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


Dupixent late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM
Clinical Trials | May 21, 2024

Dupixent late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM

Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD


Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi approved by USFDA
Clinical Trials | May 20, 2024

Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi approved by USFDA

95.7% of patients responded to Breyanzi in the TRANSCEND FL trial


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


Zydus receives final approval from USFDA for Dexamethasone Tablets
Drug Approval | May 13, 2024

Zydus receives final approval from USFDA for Dexamethasone Tablets

Dexamethasone Tablets USP, 1 mg had annual sales of US$ 1.8 mn in the United States (IQVIA MAT March 24)


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

Briefs: Lupin and Aurobindo Pharma

Lupin updates on shipment of Mirabegron ER Tablets


Cipla receives 1 observation from USFDA for Kurkumbh facility
Drug Approval | May 10, 2024

Cipla receives 1 observation from USFDA for Kurkumbh facility

The company is committed to address this observation comprehensively within stipulated time


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