Top Industry News
- EMA- Guideline on Active Substance Master File Procedure
- FDA Finalizes Guidance on Changes to Device Manufacturing Sites
- TGA- Regulation of Software as a Medical Device
- FDA Tweaks Final Guidance for PMAs and Device BLAs
- EMA- Draft Guideline on Quality and Equivalence of Topical Products
- FDA Finalizes Rule to Simplify Medical Device Classification Procedures
- FDA Withdraws Proposed Rule on Generic Label Changes
Mergers & Acquisitions
- Astellas Acquires Potenza Therapeutics
- Amag Pharmaceuticals Enters Into Definitive Merger Agreement to Acquire Perosphere Pharmaceuticals
- Akebia Therapeutics and Keryx Biopharmaceuticals Complete Merger, Creating Fully Integrated Renal Company
- Synergy Pharmaceuticals Announces Agreement for Bausch Health to Acquire Its Business Assets
- 10x Genomics Acquires Spatial Transcriptomics