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3491 News Found

FDA expands Repatha indication to adults at risk of major cardiovascular events from uncontrolled LDL-C
News | August 28, 2025

FDA expands Repatha indication to adults at risk of major cardiovascular events from uncontrolled LDL-C

The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia


FDA approves Coya Therapeutics’ trial of COYA 302 for ALS
News | August 28, 2025

FDA approves Coya Therapeutics’ trial of COYA 302 for ALS

As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya


Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra
Policy | August 27, 2025

Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra

The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion


Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection
Drug Approval | August 26, 2025

Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited


Akums Drugs and Pharmaceuticals signs framework agreement with Govt. of Zambia
News | August 24, 2025

Akums Drugs and Pharmaceuticals signs framework agreement with Govt. of Zambia

This project shall be implemented through incorporation of a new joint venture company in Zambia


FDA approved Dawnzera in US as first and only RNA-targeted prophylactic treatment for hereditary angioedema
Drug Approval | August 24, 2025

FDA approved Dawnzera in US as first and only RNA-targeted prophylactic treatment for hereditary angioedema

Dawnzera demonstrated significant and sustained HAE attack rate reduction and long-term disease control


AbbVie announces positive topline results from second Phase 3 UP-AA trial evaluating Upadacitinib
News | August 23, 2025

AbbVie announces positive topline results from second Phase 3 UP-AA trial evaluating Upadacitinib

The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study


Corbion and Kuehnle join forces to develop natural Astaxanthin from algae fermentation
Biotech | August 23, 2025

Corbion and Kuehnle join forces to develop natural Astaxanthin from algae fermentation

Astaxanthin is a powerful antioxidant and red-orange carotenoid pigment found in various aquatic organisms


Vivo Bio Tech secures pre-clinical testing contract valued at Rs.10.75 Cr
News | August 22, 2025

Vivo Bio Tech secures pre-clinical testing contract valued at Rs.10.75 Cr

Vivo Bio Tech will have end-to-end responsibility for conducting the full spectrum of pre-clinical safety and regulatory studies


NATCO launches Bosentan Tablets for oral suspension in US with 180-day exclusivity
News | August 21, 2025

NATCO launches Bosentan Tablets for oral suspension in US with 180-day exclusivity

NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity