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
As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
The FDA also expanded Repatha’s use as monotherapy to include patients with homozygous familial hypercholesterolemia
The new lineup includes CereTom Elite, OmniTom Elite, OmniTom Elite PCD, and BodyTom 32/64
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
AiMeD noted that proposed GST changes—to either 5% or 18%—both present significant risks requiring carefully nuanced consideration
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
The complex four-hour surgery was performed by a multidisciplinary team of doctors
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