Krystal Biotech: Preparing To Chase Following Positive CHMP Opinion For VYJUVEK
Krystal Biotech's VYJUVEK, a first-mover gene therapy for DEB, has received a positive CHMP recommendation. Read why KRYS ...
Novartis5d
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G)
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 ...
Pharmaceutical Technology on MSN18h
EMA to review GSK’s Nucala for COPD treatment expansion
The European Medicines Agency (EMA) has agreed to review GSK’s application of expanding Nucala’s (mepolizumab) use as add-on ...
FDA Approves Expanded Use Of Novartis Rare Disease Drug As Only Treatment For Rare Type Of Kidney Disease
Novartis' Fabhalta receives FDA approval for C3 glomerulopathy, expanding its kidney disease portfolio as global regulatory ...
Valneva Responds to French Government’s Call for Vaccine Supply of IXCHIQ® against Chikungunya Outbreak in La Réunion
Chikungunya cases have spiked substantially in La Réunion since early 2025, with 8,600 cases recorded and almost 3,000 new cases during the week of March 3 to 9, 2025 1. Similar to the 2005-2006 ...
Medindia5d
Novartis receives third FDA approval for oral Fabhalta (iptacopan) - the first and only treatment approved in C3 glomerulopathy (C3G)
Novartis Media Relations E-mail: [email protected] Novartis Investor Relations Central investor relations line: +41 61 ...
Clinical Trials Arena on MSN1d
Rising Sirturo resistance highlights urgent need for new TB therapies
Today marks World TB Day 2025 with the WHO calling for more investment into TB treatment and research globally.
The Manila Times19h
X4 Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
BOSTON, March 25, 2025 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results ...
pharmaphorum4d
When measuring European regulatory approval, the timestamp matters
They consider the FDA compared with the EMA in this ... despite a positive CHMP opinion. This may indicate the applicant's belief that the drug would not ultimately be approved by the EC.
Morningstar1d
Can-Fite Initiates Pivotal Phase 3 Psoriasis Study of its Oral Drug Piclidenoson with FDA & EMA-Approved Protocol
Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application (NDA) to the U.S. FDA and Marketing Authorization Plan (MAA) to the EMA. Piclidenoson is a novel ...
Pharmabiz4d
US FDA approves Novartis’ oral Fabhalta for treatment of adults with C3 glomerulopathy
US FDA approves Novartis’ oral Fabhalta for treatment of adults with C3 glomerulopathy: Basel Saturday, March 22, 2025, 09:00 Hrs [IST] Novartis announced that oral Fabhalta (ip ...