The US Food and Drug Administration (FDA) has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. In addition, […]

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for the mRNA respiratory syncytial virus (RSV) […]

At its June 27 meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting marketing authorizations for four […]

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given negative opinions for two drugs intended to treat amyotrophic lateral sclerosis (ALS) […]

At its June 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave Winrevair (sotatercept; Merck Sharp & Dohme) a positive […]

The European Medicines Agency has recommended the first emergency treatment for allergic reactions to be administered as a nasal spray, not as an injection. Eurneffy (epinephrine) […]

The US Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US) for adults with relapsed or refractory follicular lymphoma after two or more […]

The European Commission has approved Fruzaqla (fruquintinib; Takeda) as a monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC). The approval is for […]

The Food and Drug Administration has approved a topical anticholinergic, sofpironium topical gel, 12.45%, for the treatment of primary axillary hyperhidrosis in adults and children aged […]