Pharma News, 2023

Janssen reported positive topline results from a phase 2 trial of nipocalimab for the treatment of pregnant adults at high risk for severe hemolytic disease of the fetus and newborn (HDFN), which o...

The FDA has granted regenerative medicine advanced therapy (RMAT) designation to Rocket Pharmaceutical’s investigational adeno-associated virus (AAV)-based gene therapy for the treatment of Danon di...

The FDA has granted priority review to a new drug application (NDA) by Sage Therapeutics and Biogen for zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (P...

Roche subsidiary Genentech announced positive results from its global phase 3 COMMODORE 2 study evaluating crovalimab for people with paroxysmal nocturnal hemoglobinuria (PNH) who have not been pr...

Biotech Aldeyra Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational...

The world's first-in-class candidate substance against idiopathic pulmonary fibrosis, 'Bersiposocin' (DWN12088), which is under development Daewoong Pharmaceutical, has entered its Phase II clinica...

More than two years after receiving an FDA rejection, Mesoblast has resubmitted its biologics license application (BLA) for remestemcel-L, a treatment for children afflicted with steroid-refractory...

Eisai has begun to sell Leqembi (lecanemab), its newly approved Alzheimer’s treatment, in the U.S.

Certa Therapeutics  today announces ground-breaking clinical trial data for FT011, its novel therapy for the treatment of serious inflammatory and fibrotic diseases. ...

The reversal of fortunes for Gilead Sciences' Trodelvy in an advanced form of breast cancer is complete, with an FDA approval unlocking what could be a sizeable new market for the TROP2-targeting d...

Mitsubishi Chemical Group has shut down Quebec-based Medicago’s operations “in light of significant changes to the COVID-19 vaccine landscape” since the approval of the company’s plant-bas...

EP0042 is being developed to treat AML patients who have developed FLT3 inhibitor resistance.