FDA accepts to review Pfizer’s BLA for meningococcal B vaccine candidate
The US FDA has also granted priority review status for the BLA with an expected Prescription Drug User Fee Act (PDUFA) action date of 14 February 2015. Pfizer
The US Food and Drug Administration (FDA) has approved Pfizer’s Tukysa (tucatinib) along with pertuzumab and trastuzumab as a maintenance therapy for breast cancer.
The parallel-group, single-dose study met the criteria for clinical PK similarity on all three required, prospectively defined, PK endpoints: maximum serum concentration (Cmax), area under the time-concentration curve
RP101 is a proprietary, first-in-class, heat shock protein 27 (Hsp27) inhibitor, administered orally, which may prevent the induction of resistance to chemotherapy (chemoresistance), thus maintaining sensitivity of the