RECOMMENDED CASH OFFER for MARIADB PLC by MERIDIAN BIDCO LLC which is an Affiliate of K1 INVESTMENT MANAGEMENT, LLC as manager of K5 PRIVATE INVESTORS, L.P. prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
FDA Issues CRL for HEPLISAV-B in Adults on Hemodialysis hcplive.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from hcplive.com Daily Mail and Mail on Sunday newspapers.
Takeda Pharmaceutical : FY2023 (April 2023-March 2024) Quarter 4 Quarterly Financial Report marketscreener.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from marketscreener.com Daily Mail and Mail on Sunday newspapers.
Abeona Therapeutics Provides Regulatory Update on Pz-cel tmcnet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from tmcnet.com Daily Mail and Mail on Sunday newspapers.
The health regulator sought certain additional data to satisfy requirements pertaining to chemistry, manufacturing, and controls before the treatment, called pz-cel, can be approved, in its so-called "complete response letter". The drug developer is seeking approval for the treatment in patients with recessive dystrophic epidermolysis bullosa, where the skin becomes fragile and blisters can appear through rubbing or exposure to heat. FDA in its response letter indicated that the proposed timing of the data submission would not allow sufficient time to complete its review by May 25, the set deadline to decide on the application.