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Results For "approval"

2618 News Found

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction
Drug Approval | July 22, 2023

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU


M&A activity of pharma CMOs will continue despite challenging borrowing environment, says GlobalData
News | July 20, 2023

M&A activity of pharma CMOs will continue despite challenging borrowing environment, says GlobalData

CMOs showed an increasing reluctance to take on debt in 2022


Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories
Drug Approval | July 20, 2023

Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories

Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial


SEBI approves Piramal Pharma’s Rs 1,050-crore rights issue
News | July 19, 2023

SEBI approves Piramal Pharma’s Rs 1,050-crore rights issue

Piramal Pharma plans to offer fully paid-up equity shares through a rights issue to its existing eligible shareholders


Briefs: Link Pharma Chem and Zydus
News | July 11, 2023

Briefs: Link Pharma Chem and Zydus

USFDA concludes inspection at Zydus' formulation manufacturing facility at SEZ 2, Ahmedabad


Novavax's Nuvaxovid receives full marketing authorization in the EU
News | July 10, 2023

Novavax's Nuvaxovid receives full marketing authorization in the EU

Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU


Moderna announces regulatory submissions for its RSV vaccine
News | July 10, 2023

Moderna announces regulatory submissions for its RSV vaccine

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia


Thermo Fisher Scientific to acquire CorEvitas for $912.5 million
News | July 10, 2023

Thermo Fisher Scientific to acquire CorEvitas for $912.5 million

Advances clinical research capabilities with leading regulatory grade registries platform


Croda completes acquisition of Solus Biotech
News | July 06, 2023

Croda completes acquisition of Solus Biotech

This acquisition will significantly strengthen Croda’s Beauty Actives portfolio and increases its exposure to targeted prestige segments


Syngene to acquire multi-modal facility from Stelis Biopharma
News | July 05, 2023

Syngene to acquire multi-modal facility from Stelis Biopharma

Adding 20,000 liters of installed biologics drug substance manufacturing capacity