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The FDA has finalized guidance on post-approval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH). Read More
Bayer said its experimental drug finerenone delayed the progression of chronic kidney disease (CKD) in patients with type 2 diabetes in a late-stage study. Read More
The FDA has approved Smart Immune’s investigational new drug (IND) application for ProTcell, a T cell progenitor-based biotherapy candidate, marking the first time the agency has cleared a product of its kind to enter clinical trials. Read More
The Department of Justice and the American Civil Liberties Union (ACLU) have filed a joint motion calling on a U.S. district court in to wait until December to decide on a high-profile case over the abortion pill, Mifeprex (mifepristone), while the FDA reviews the drug’s risk evaluation and mitigation strategy (REMS). Read More
AstraZeneca (AZ) may forgo seeking Emergency Use Authorization (EUA) from the FDA and instead go for full approval for its COVID-19 vaccine off the bat. Read More
Sponsors of drug trials should publish clinical trial reports without redacting confidential information, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) said in a statement last week. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has issued its first drug approval under Project Orbis, a joint program by the FDA, Canada, Australia, Switzerland, Singapore, Brazil and the UK for reviews of cancer treatments. Read More