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7524 News Found

ExeGi Pharma announces first patient enrollment in the PROF Trial of EXE-346
News | December 10, 2023

ExeGi Pharma announces first patient enrollment in the PROF Trial of EXE-346

First published clinical trial using live biotherapeutic candidate in Covid-19 patients suggests role in improving outcomes


Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease
Drug Approval | December 09, 2023

Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease

Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment


Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Drug Approval | December 08, 2023

Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH

Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions


Akums acquires new facility in Baddi to enhance tablet manufacturing capacity
News | December 07, 2023

Akums acquires new facility in Baddi to enhance tablet manufacturing capacity

his marks the 12th formulation facility under Akums, and the second in Baddi, a strategic move with an aim to enhance Akums’ manufacturing capabilities.


Zydus receives final approval from the USFDA for methylene blue injection
Drug Approval | December 07, 2023

Zydus receives final approval from the USFDA for methylene blue injection

Methylene blue is a cationic thiazine dye that necessitates specialised capabilities and expertise to develop and manufacture the product


Lupin receives approval from U.S. FDA for Varenicline Tablets
News | December 07, 2023

Lupin receives approval from U.S. FDA for Varenicline Tablets

Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.


Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets
Drug Approval | December 07, 2023

Indoco Remedies receives tentative ANDA approval from USFDA for Canagliflozin Tablets

This product will be manufactured by Indoco Remedies at their manufacturing facility located at Goa


Sun Pharmaceutical inks licensing agreement with Aclaris Therapeutics
News | December 06, 2023

Sun Pharmaceutical inks licensing agreement with Aclaris Therapeutics

The agreement includes an upfront payment of US$15 million, regulatory and commercial milestones, and royalties


Granules India received ANDA approval for Sildenafil for oral suspension
Drug Approval | December 06, 2023

Granules India received ANDA approval for Sildenafil for oral suspension

The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million


Zydus receives final approval from the USFDA for Ivabradine Tablets
Drug Approval | December 06, 2023

Zydus receives final approval from the USFDA for Ivabradine Tablets

Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States