Pure Global launches the first flat-fee pricing model in the MedTech industry for full-service medical device market access, designed to simplify regulatory compliance and provide transparent costs ...
By Maggie Fick and Michael Erman SAN FRANCISCO, Jan 26 (Reuters) - Artificial intelligence has yet to deliver on the most challenging aspect of drug development -- finding new molecules that lead to ...
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 ...
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 ...
SEATTLE--(BUSINESS WIRE)--Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug Master File (DMF) to the U.S.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for its anti-tissue ...
Belite Bio (BLTE) stock outlook: tinlarebant clinical data, 2026 filings, key FDA/EU risks, and $165/share valuation. See if ...
Moderna has filed for marketing authorization in the U.S., EU, Canada and Australia for mRNA-1010 CAMBRIDGE, MA / ACCESS Newswire / January 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today provided an ...
Oncoscope launches the first Real-time, AI-supported Living Systematic Literature Review designed for enterprise-wide ...
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