Sanofi and GlaxoSmithKline delay their Covid-19 vaccine program to improve immune response in older adults.
FDA grants an emergency use authorization for Pfizer-BioNTechs Covid-19 vaccine amid a White House threat for commissioner Stephen Hahn to otherwise r...
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...