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Results For "regulatory-approval"

338 News Found

Syngene Q1 FY 2024 revenue up 26% to Rs. 832 crores, PAT up 26% to Rs.93 Cr
News | July 26, 2023

Syngene Q1 FY 2024 revenue up 26% to Rs. 832 crores, PAT up 26% to Rs.93 Cr

Acquisition of biologics manufacturing facility in Bangalore to complete by the end of the third quarter in FY 24


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


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


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


Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir
News | June 27, 2023

Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir

Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.


Nouryon launches new high-efficiency spherical silica for peptide-based pharmaceuticals
News | June 21, 2023

Nouryon launches new high-efficiency spherical silica for peptide-based pharmaceuticals

This patent-pending, high-efficiency chromatography media is used for the purification of novel peptide-based pharmaceuticals in the GLP-1 agonist class including type 2 diabetes and obesity treatments


Novartis to acquire Chinook Therapeutics for US$ 3.2 bn
News | June 12, 2023

Novartis to acquire Chinook Therapeutics for US$ 3.2 bn

Chinook Therapeutics is a clinical-stage biopharmaceutical company with two high-value, late-stage assets in development for IgA nephropathy (IgAN), a rare, progressive chronic kidney disease


Capnopharm receives CE certification for its new CapnoPen technology
News | May 31, 2023

Capnopharm receives CE certification for its new CapnoPen technology

Capnopharm’s new CapnoPen is the first PIPAC nebulizer to obtain CE marking under the new MDR regulation 2017/745


Lonza launches TheraPEAK T-VIVO cell culture medium to accelerate cell therapy development
News | May 24, 2023

Lonza launches TheraPEAK T-VIVO cell culture medium to accelerate cell therapy development

Lonza launches the TheraPEAK T-VIVO Cell Culture Medium with a novel chemically defined formulation developed to optimize and streamline CAR T-cell manufacturing


Baxter  to sell its BioPharma Solutions Business to Advent International and Warburg Pincus for US $4.25billion
News | May 09, 2023

Baxter to sell its BioPharma Solutions Business to Advent International and Warburg Pincus for US $4.25billion

Proposed divestiture of BioPharma Solutions (BPS) further streamlines Baxter’s strategic focus and represents an important milestone in its ongoing business transformation