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

AbbVie to acquire Gilgamesh Pharmaceuticals’ bretisilocin for $1.2 billion

Lighthouse receives $49.2 million NIA grant to advance phase 2 study of Alzheimer’s disease

LHP588 is an oral, brain-penetrant lysine-gingipain (Kgp) inhibitor designed to block the key virulence factor of P. gingivalis

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

Samsung India introduces next-gen mobile CT imaging solutions

The new lineup includes CereTom Elite, OmniTom Elite, OmniTom Elite PCD, and BodyTom 32/64

Gilead’s Yeytuo approved in EU for HIV prevention

This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option

GST rejig may impact competitiveness of medical devices: AiMeD

AiMeD noted that proposed GST changes—to either 5% or 18%—both present significant risks requiring carefully nuanced consideration

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

Terumo India launches Terufusion advanced infusion systems in India

Terufusion Advanced Infusion Systems combine a smart syringe pump, smart infusion pump, and pump monitoring system software for precise and efficient drug administration

India showcases herbal GMP leadership at WHO-SEARO regional workshop in Mumbai

Delegates also visited Emami’s WHO-GMP-certified manufacturing plant and Zandu Foundation for Healthcare farms for hands-on exposure to quality practices,