Novartis6d
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 ...
pharmaphorum2d
EU gives narrower label to Apellis, Sobi's PNH drug
Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label ... Both the EMA and FDA ...
pharmaphorum5d
When measuring European regulatory approval, the timestamp matters
When comparing the FDA and EMA, we found that many of the calculations that determine this relative speed have used time of approval and time of market authorization, interchangeably. This ...
WADA5d
Athlete Biological Passport
WADA’s Athlete Biological Passport Operating Guidelines (ABP Guidelines) were first approved by WADA’s Executive Committee and took effect on 1 December 2009. This first version contained a ...
The Pharma Letter6d
Latest Pharma and Biotech News
21 March 2025 China's burgeoning biotech R&D capabilities are attracting increasing international attention, with non-Western countries actively seeking partnerships. At the BIOCHINA event in Suzhou ...