The European Medicines Agency (EMA) has agreed to review GSK’s application of expanding Nucala’s (mepolizumab) use as add-on ...

GSK plc GSK announced that the European Medicines Agency (“EMA”) has accepted for review a regulatory filing, seeking ...

Krystal Biotech's VYJUVEK, a first-mover gene therapy for DEB, has received a positive CHMP recommendation. Read why KRYS ...

Novartis' Fabhalta receives FDA approval for C3 glomerulopathy, expanding its kidney disease portfolio as global regulatory ...

Novartis Media Relations E-mail: [email protected] Novartis Investor Relations Central investor relations line: +41 61 ...

Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G) Fabhalta is the only oral alternative complement pathway ...

DelveInsight's "DARZALEX Market Size, Forecast, and Market Insight Report" highlights the details around DARZALEX, a human ...

TG Therapeutics' strong cash position and Briumvi success fuel growth potential. Find out why TGTX stock is rated a strong ...

Europe’s drug regulatory agency has given Kizfizo a negative opinion for the second time, following one from November 2024.

“We are very pleased with the productive dialogue with the EMA Pediatric Committee and the positive PIP opinion. This approval marks a major regulatory milestone towards the submission of our ...

"We are very pleased with the productive dialogue with the EMA Pediatric Committee and the positive PIP opinion. This approval marks a major regulatory milestone towards the submission of our ...