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Results For "USFDA"

1210 News Found

FDA approves AbbVie’s mavyret as first and only treatment for acute hepatitis C
Drug Approval | June 13, 2025

FDA approves AbbVie’s mavyret as first and only treatment for acute hepatitis C

Now approved for both acute and chronic HCV in adults and children aged 3 and above


Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa
Drug Approval | June 12, 2025

Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa

Zydus receives EIR for the API manufacturing facility at Ankleshwar


FDA approves Merck’s enflonsia for prevention of RSV in infants
Drug Approval | June 12, 2025

FDA approves Merck’s enflonsia for prevention of RSV in infants

Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months


Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer
Drug Approval | May 29, 2025

Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer

This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition


Granules India posts Q4 FY25 PAT at Rs. 152 Cr
News | May 28, 2025

Granules India posts Q4 FY25 PAT at Rs. 152 Cr

The company reported sustained increase in formulations' share despite slowdown in productivity of Gagillapur facility


Sun Pharma to raise stake in US-based Pharmazz to 22.7%
Biopharma | May 24, 2025

Sun Pharma to raise stake in US-based Pharmazz to 22.7%

Sun Pharma will invest up to $25 million in US-based Pharmazz Inc, raising its stake to 22.7%


Briefs: Dr. Reddy's Laboratories, Relonchem,  Shilpa Pharma Lifesciences and Shanmuga Hospital
News | May 18, 2025

Briefs: Dr. Reddy's Laboratories, Relonchem, Shilpa Pharma Lifesciences and Shanmuga Hospital

Shilpa Pharma Lifesciences, Unit-1, received EIR from USFDA


Remedium Lifecare secures Rs. 182.7 crore export deal
News | May 16, 2025

Remedium Lifecare secures Rs. 182.7 crore export deal

The CDMO upgrade represents a transformational step for Remedium Lifecare