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3131 News Found

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


Strides receives USFDA approval for Sevelamer Carbonate Tablets
Drug Approval | May 11, 2024

Strides receives USFDA approval for Sevelamer Carbonate Tablets

Sevelamer Carbonate Tablets approval consolidates the company's position in the Sevelamer segment


Alembic Pharmaceuticals receives 5 USFDA product approvals in Q1 FY25
Drug Approval | May 10, 2024

Alembic Pharmaceuticals receives 5 USFDA product approvals in Q1 FY25

Receives 3 final and 2 tentative product approvals thus far in Q1FY25


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


AstraZeneca completes equity investment agreement with Cellectis
News | May 08, 2024

AstraZeneca completes equity investment agreement with Cellectis

Cellectis is also eligible to receive an investigational new drug (IND) option fee and development


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