Additional competition in PNH will come from Novartis’ recently approved oral therapy Fabhalta (iptacopan), a targeted factor B inhibitor that in trials was shown to be more effective than ...

Roche's PiaSky has been approved by the European Commission, becoming the first therapy for rare blood disorder paroxysmal nocturnal haemoglobinuria (PNH) that can be given by monthly subcutaneous ...

SEATTLE, WA, USA I June 27, 2025 I Omeros Corporation (Nasdaq: OMER) today announced the recent submission of a Marketing Authorization Application (MAA) to ...

Panelists discuss the promising results of the ReNeu trial for mirdametinib, highlighting its significant tumor shrinkage and ...

ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These ...

Benlysta is supplied as a single-dose prefilled autoinjector or prefilled syringe containing 200mg/mL of belimumab for SC use. The prefilled syringe has not been studied in pediatric patients aged ...

The UK’s National Institute for Health and Care Excellence (Nice) has declined to recommend two new Alzheimer’s drugs for ...

Approved eight months ago for a certain class of patients with both hemophilia A or B, Pfizer’s Hympavzi has now shown its ...

Only five days after FDA approval of Yutrepia, Liquidia announced its first commercial shipment of the therapy, making prescriptions available to patients at specialty pharmacies. “We have moved with ...

The Food and Drug Administration has approved Harliku (nitisinone) for the reduction of urine homogentisic acid in adult patients with alkaptonuria.

Convatec announced that it received FDA approval for the delivery of a Parkinson's disease therapy through its Neria Guard ...