The tech giant’s new AI platform aims to make drug discovery faster and cleaner.
The laborious process of naming a pharmaceutical takes months and sometimes years of brainstorming, trademark review, legal ...
Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Applicatio ...
A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
Illustration of New Drug Application paperwork surrounded by pills, vials, and DNA. The US Food and Drug Administration approved 46 new molecular entities in 2025. Credit: C&EN/Shutterstock The year ...
Cathy Burgess, Yifan Wang, Ph.D. A new federal law allows the Food and Drug Administration to provide more detailed feedback earlier in the abbreviated new drug application (ANDA) process, reducing a ...
Zanzalintinib plus Tecentriq showed improved survival in metastatic colorectal cancer patients compared to Stivarga in the STELLAR-303 trial. The FDA accepted the new drug application for this ...
In a new draft guidance document, “New Clinical Investigation Exclusivity (3‑Year Exclusivity) for Drug Products: Questions and Answers,” FDA is stepping in to help drug sponsors prepare a request for ...
New Drug Application (NDA) based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 clinical trial CAMBRIDGE, Mass., April 7, 2026 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a ...
Potential first FDA-approved treatment option for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting NEW HAVEN, Conn., April 01, ...
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