Roche CE mark Contivue advances Susvimo for nAMD in Europe, potentially benefiting 1.7 million people.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
Biohaven Vyglxia FDA approval leads to launch preparations, with a patient hub and sales force ready.
FDA approves Leqembi Iqlik as a weekly subcutaneous injection for Alzheimer’s, enhancing patient convenience and safety.
FDA ultra-rare disease drugs review pathway targets conditions affecting fewer than 1,000 people in the U.S.
FDA waives trial requirement for Stelera biosimilar, marking a regulatory breakthrough and potentially reducing costs.
The end of Covid vaccine emergency authorizations may limit the availability of shots for young, healthy kids.
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 …
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. •