Zydus Therapeutics’ PBC data: The drug saroglitazar met the primary endpoint in a Phase 2b/3 trial for a rare autoimmune disease that affects the bile ducts, the …
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
The vaccine is approved for adults aged 65 years and older and individuals aged 5 to 64 years with underlying conditions
The authorised generic of Carac (fluorouracil cream) 0.5 per cent is approved by the USFDA and manufactured in Texas for the treatment of actinic keratoses
Alembic Pharmaceuticals receives USFDA approval for Tretinoin Cream USP (0.025%). • The cream is therapeutically equivalent to Bausch Health’s Retin-A Cream. •
Roche’s Atezolizumab injection (Tecentriq) approved for subcutaneous use in India. • Approval requires Roche to conduct a Phase IV clinical trial. • Subcutaneou
FDA launches a program to streamline the construction of drug manufacturing sites in the U.S., enhancing domestic production capabilities.