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Results For "Food-and-Drug-Administration"

1262 News Found

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


WACKER expands production capacity for biopharmaceuticals in San Diego
News | May 08, 2024

WACKER expands production capacity for biopharmaceuticals in San Diego

Wacker Biotech US, a wholly owned subsidiary of Wacker Chemie AG, specializes in the microbial production of pDNA


USFDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab
Drug Approval | May 08, 2024

USFDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab

Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor


Alembic Pharmaceuticals receives EIR from USFDA for oncology formulation facility
Drug Approval | May 07, 2024

Alembic Pharmaceuticals receives EIR from USFDA for oncology formulation facility

With this, for all our USFDA facilities, EIRs are in place