BARCELONA, Spain--(BUSINESS WIRE)--Rimsys, the leading provider of Regulatory Information Management (RIM) software for the medtech industry, today announced the release of Rimsys 5 at the MedTech ...
In 2023, the FDA rejected a small pharmaceutical company's new drug application (NDA) with a Refusal-to-File (RTF) decision. This letter provided information on a range of issues within the submission ...
PTC Therapeutics, Inc. (NASDAQ:PTCT) had been able to submit its New Drug Application [NDA] to the FDA for Upstaza for AADC Deficiency in March 2024. The importance of this is that not only has the ...
PRINCETON, N.J., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it has successfully supported 300 completed submissions to ...
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