A Grid news report uses Linkedin data to estimate how many former FDAers are now working in regulated companies and discusses the ethical issues raise...
Alnylam Pharmaceuticals plans to file an NDA submission late this year for patisiran, indicated for treating transthyretin-mediated amyloidosis with c...
Federal Register notice: FDA announces a 9/7 Peripheral and Central Nervous System Drugs Advisory Committee meeting that will review Amylyx Pharmaceut...
FDA clears a Glaukos 510(k) for its iStent Infinite Trabecular Micro-Bypass System and its use in a standalone procedure to reduce elevated intraocula...
Attorney Keeley McCarty says a recent government suit against Promothesus Group demonstrates the government is willing to use the False Claims Act to ...
FDA warns Los Angeles, CA-based DSP Skin Care about CGMP and other violations, some repeated from 2018, in its manufacturing of finished drugs.
Allarity Therapeutics says it is no longer economically feasible to pursue its dovitinib as a monotherapy for some renal cancers and it is refocusing ...
FDA publishes a draft guidance on the electronic submission of expedited individual case safety reports from IND-exempt BA/BE studies through the adve...
