Jen Lamppa, VP of Commercial Strategy at Inovalon, says that RWD will be held to the same scrutiny as trial data if used in ...
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 ...
By Maggie Fick and Michael Erman SAN FRANCISCO, Jan 26 (Reuters) - Artificial intelligence has yet to deliver on the most ...
Oncoscope launches the first Real-time, AI-supported Living Systematic Literature Review designed for enterprise-wide ...
Belite Bio (BLTE) stock outlook: tinlarebant clinical data, 2026 filings, key FDA/EU risks, and $165/share valuation. See if ...
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 ...
BCG unresponsive non-muscle invasive bladder cancer (NMIBC) in the papillary indication: Anticipated supplemental biologics license application (BLA) submission in 2025 Alternative source of BCG in ...
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 ...
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 ...
ST. LOUIS, March 04, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that ...
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