Samsung Bioepis Announces Analytical Similarity Data on SB11 (ranibizumab) at the ARVO Annual Meeting 2021 benzinga.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from benzinga.com Daily Mail and Mail on Sunday newspapers.
BioMarin Announces First Quarter 2021 Financial Results and Corporate Updates
- Full-year 2021 Financial Guidance Reaffirmed
- Total Revenues Grew 9% in the First Quarter 2021 Compared to First Quarter 2020, Excluding Kuvan
- Regulatory Actions in Europe for Vosoritide and Valoctocogene Roxaparvovec Tracking as Expected; BioMarin Anticipates CHMP Opinion in June for Vosoritide and June Re-submission of MAA for Valoctocogene Roxaparvovec
- FDA Review of Vosoritide Proceeding; PDUFA Target Action Date Extended to November 20, 2021 to Provide Time for Review of Recently Submitted 2-year Phase 3 Results
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- FN Media Group Presents Microsmallcap.com Market Commentary NEW YORK, April 28, 2021 /PRNewswire/ There are currently thousands of health conditions that affect people's lives for
Published: Apr 26, 2021
NEWTON, Mass., April 26, 2021 /PRNewswire/ Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the European Medicines Agency (EMA) has validated the Company s Type II Variation Marketing Authorization Application (MAA), which seeks to expand the currently authorized indication for NEXPOVIO® in the European Union to include, in combination with Velcade® (bortezomib) and low-dose dexamethasone, the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Validation of the application confirms the submission is complete to begin the EMA s review process. The MAA is supported by the positive results from the pivotal Phase 3 BOSTON study, which evaluated once-weekly selinexor in combination with once-weekly Velcade® and low-dose dexamethasone (SVd) compared to standard twice-weekly Velcade® plus low-dose dexamethasone