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Results For "regulatory-approval"

338 News Found

Merck closes license agreement for LM-299
News | December 21, 2024

Merck closes license agreement for LM-299

Merck will record a pre-tax charge relating to the upfront payment of $588 million


Bayer announces positive topline resukts for Aflibercept 8 mg in phase III study
Clinical Trials | December 17, 2024

Bayer announces positive topline resukts for Aflibercept 8 mg in phase III study

Demonstrates vision gains with extended treatment intervals in retinal vein occlusion


Amalgamation of Gujarat Themis Biosyn with Themis Medicare
News | November 23, 2024

Amalgamation of Gujarat Themis Biosyn with Themis Medicare

The Scheme is subject to approval of the secured creditors and shareholders of TML and GTBL


AbbVie to acquire Aliada Therapeutics
News | November 01, 2024

AbbVie to acquire Aliada Therapeutics

Strengthening focus in Alzheimer's disease and neuroscience pipeline


Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years
News | October 19, 2024

Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years

Results from the open-label extension study of PHOTON demonstrate patients with diabetic macular edema (DME) randomized to Eylea 8 mg maintained visual and anatomic improvements at the end of three years


Strides Pharma's CDMO arm OneSource raises Rs. 801 crore in pre-listing round
News | October 16, 2024

Strides Pharma's CDMO arm OneSource raises Rs. 801 crore in pre-listing round

The share subscription agreements are being executed at a pre-money equity value of US$ 1.65 billion


Akums Drugs enters into license and distribution agreement with Triple Hair, Canada
News | October 16, 2024

Akums Drugs enters into license and distribution agreement with Triple Hair, Canada

Akums Drugs will undertake this development and commercialization in India


OneSource unveils new brand identity at CPHI Milan
News | October 11, 2024

OneSource unveils new brand identity at CPHI Milan

Aims to achieve CDMO sales of US$ 400 million by 2028


Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable
News | September 14, 2024

Zydus announces licensing and supply agreement for two Gadolinium based MRI injectable

Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus’ injectable portfolio for the US market


Granules India’s Gagillapur facility completes USFDA inspection with six observations
Drug Approval | September 09, 2024

Granules India’s Gagillapur facility completes USFDA inspection with six observations

The recent inspection covered both cGMP and PAI processes