Drug Approval | April 20, 2026
Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid
The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics
The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics
ENFLONSIA is a long-acting monoclonal antibody designed to shield infants through a typical five-month RSV season with a single, fixed dose
The upcoming multi-center, multinational Phase 1 study will evaluate safety, tolerability, pharmacokinetics, and early signs of efficacy
The approval now covers procedures using 10-14F inner diameter and up to 17F outer diameter procedural sheaths
Hyderabad-based peptide specialist strengthens complex generics credentials as Apotex prepares for U.S. commercialization of semaglutide injection
The FDA clearance of Zeto New Wave marks the company’s third cleared device, alongside Zeto WR19 and Zeto ONE
The approval clears the way for a US study at leading clinical centers to evaluate the safety and effectiveness of VDYNE’s system in patients
The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market
Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation
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