Apellis Pharmaceuticals says it will file an NDA for pegcetacoplan, an investigational, targeted C3 therapy treating geographic atrophy secondary to a...
PharmaTher Holdings retains former CDER antipsychotic guru Thomas Laughren as a regulatory affairs advisor to help a depression therapy.
FDA approves AbbVies novel migraine prevention drug Qulipta.
FDA publishes a draft guidance on investigator responsibilities for safety reporting for INDs and IDEs.
FDA publishes a draft guidance on microbiological quality control of non-sterile drugs.
Federal Register notice: FDA announces the fee rates for using a tropical disease priority review voucher for fiscal year 2022 $1,266,651.
Federal Register notice: FDA announces the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2022 $1,266,651.
Federal Register notice: FDA sets the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2022 $1,266...