Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...
(The Conversation is an independent and nonprofit source of news, analysis and commentary from academic experts.) (THE CONVERSATION) Pharmaceutical innovation saves lives. But not every “new” drug is ...
Filing based on pivotal Phase 3 ORCA-2 and ORCA-3 clinical trials demonstrating statistically significant and clinically meaningful smoking cessation FDA acceptance starts the review process and sets ...
Achieve Life Sciences, Inc. has submitted a New Drug Application (NDA) to the U.S. FDA for cytisinicline, which, if approved, would be the first new pharmacotherapy for nicotine dependence in 20 years ...
AbbVie is seeking a new way to fight chronic lymphocytic leukemia, or CLL, by combining its oncology drug Venclexta with another cancer-fighting drug. The North Chicago-based drugmaker has filed a ...
The Indian government is amending drug regulations to expedite the approval process for clinical trials and bioavailability/bioequivalence studies. These changes aim to reduce the statutory processing ...
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