Pfizer-BioNTech Booster Gains FDA Limited Authorization

Pfizer-BioNTech Booster Gains FDA Limited Authorization

Pfizer-BioNTech has been granted FDA (Food and Drug Administration) authorization for its booster shot for people aged 65 and older, as well as individuals at high risk for severe disease and those working in patient-facing healthcare, six months are their second...
MS: EMA Committee Supports Diroximel Fumarate Approval

MS: EMA Committee Supports Diroximel Fumarate Approval

European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has announced their approval of diroximel fumarate (Vumerity, Biogen Inc) for adults diagnosed with relapsing-remitting multiple sclerosis (MS). Although Diroximel fumarate is...
FDA Accepts Axsome Therapeutics NDA for AXS-07

FDA Accepts Axsome Therapeutics NDA for AXS-07

Biopharmaceutical company Axsome Therapeutics, known for developing innovative therapies for central nervous system (CNS) disorders, announced that the FDA (Food and Drug Administration) has accepted their New Drug Application (NDA) for AXS-07 for acute migraine...