Drug Approval | December 20, 2025
Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies
Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
Alport Syndrome is caused by genetic mutations affecting type IV collagen in the kidneys, ears, and eyes
Granules Consumer Health serves as Granules’ front-end division for OTC products in the US
The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration
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