Federal Register notice: FDA withdraws the approval of an Allergan Pharmaceuticals International NDA for Asacol (mesalamine) delayed-release tablets, ...
Federal Register notice: FDA announces the names of the members who will serve on its fiscal year 2020 Performance Review Board.
The International Council on Harmonization says its electronic Common Technical Document question-and-answer document has reached Step 4 of the ICH pr...
FDA authorizes the first non-prescription DTC Covid-19 test kit.
FDA releases summaries from two PDUFA 7 reauthorization negotiation meetings.
AvKare (Pulaski, TN) withdraws one lot of sildenafil 100 mg tablets and one lot of trazodone 100mg tablets due to a product mix-up that led them to be...
Torrent Pharmaceuticals recalls one lot of anagrelide capsules due to a dissolution test failure detected during routine quality testing.
Oblato says FDA has given positive detailed responses on plans for a Phase 1/2 trial of a new treatment for a rare pediatric cancer.