FDA accepts for priority review an EMD Serono and Pfizer BLA for avelumab as a treatment for patients with locally advanced or metastatic urothelial c...
AdvaMed makes its case to the HHS Inspector General for two new anti-kickback safe harbors.
Speakers at a Harvard forum on 21st Century Cures express fears that faster FDA drug approvals can lead to problems in patients.
Two FDA executives describe ways in which CDER is attempting to improve its value analysis of drugs considered for approval.
FDA releases its latest batch of Warning Letters that cites Chongqing Pharma Research Institute and Pfizers Hospira manufacturing unit.
AcelRx Pharmaceuticals submits a 505(b)(2) NDA for Dsuvia (sufentanil sublingual tablet, 30 mcg) for treating patients with moderate-to-severe acute p...
Genentech says it supports FDAs consolidation and move to electronically coded manufacturing establishments information, but it recommends alignment a...
FDA accepts for review an Antares Pharma for QuickShot Testosterone, a drug-device combination product for the delivery of testosterone enanthate usin...