Reps. Eshoo and McCaul reintroduce the Give Kids a Chance Act to authorize FDA to direct drug companies to perform pediatric cancer trials with combin...
Rep. Frank Pallone praises FDA steps to reduce the shortage of the cancer drugs carboplatin and cisplatin.
FDA publishes 46 new or revised product-specific guidances to spur the development of generic drugs.
A House Appropriations Subcommittee cuts FDAs fiscal year 2024 budget request by $600 million (8.3%).
FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend approval of a Pfizer BLA for its Abrysvo (RSVpreF) vaccine for pre...
FDA publishes two guidances to assist in the development of drugs, biologics, and vaccines for pediatric use.
FDA modifies a partial clinical hold on an Avidity Biosciences study involving AOC 1001, allowing Avidity to double the number of participants in the ...
ICU Medical recalls the replacement batteries in its in Plum A+ & Plum A+3 Infusion Systems due to a manufacturing defect by a battery supplier.