Sun Pharma Halol Plant faces an FDA export ban due to ongoing safety violations, affecting drug exports to the US.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
FDA rejection letters will be released soon after issuance, enhancing transparency in the drug review process.
FDA foreign inspections increase, targeting drug manufacturers without notice, as Commissioner Makary outlines new strategy.
Amneal FDA warning highlights use of contaminated bags in sterile injectable drugs, impacting quality control.
Roche CE mark Contivue advances Susvimo for nAMD in Europe, potentially benefiting 1.7 million people.
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.