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The FDA initially advised manufacturers that the vaccine for fall 2024 should be monovalent JN.1 vaccines, but after reviewing current data, “along with the recent rise in cases of COVID-19 in areas of the country, the agency has further determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible.” Read More
The FDA has finalized two draft documents that provide guidance for sponsors developing and testing oligonucleotides, and drugs to treat diabetic foot infections without bone or joint involvement. Read More
Over seven hours of presentations, 50 stakeholders and members of the public voiced their opinions on the FDA’s advisory committee process, focusing often on diversity as well as patient and consumer perspectives in the panels, along with improved transparency and communications. Read More
The FDA is issuing exemptions from certain requirements of the Drug Supply Chain Security Act (DSCSA) to small dispensers such as pharmacies until Nov. 27, 2026. Read More
Due to a combination of confounding factors in the regulatory system and the market, patients in Europe wait an average of 531 days to access new medicines, according to three new reports published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) this week. Read More
The US Supreme Court tossed out a challenge to the FDA’s approval of the use of the abortion drug mifepristone (Mifeprex), ruling that the plaintiffs did not have standing to bring the action. Read More
The House’s fiscal 2025 Agriculture-FDA bill, released Monday, keeps spending almost flat, providing the FDA with $6.75 billion in total funding, short of the agency’s $7.2 billion budget request. Read More
Alzheimer’s drugmakers including Biogen, Eli Lilly and Eisai, as well as consumer advocacy group Public Citizen, have characterized a recent FDA guidance on developing drugs for Alzheimer’s as lacking in specifics for later-stage disease progression. Read More