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 ...
Patent reforms could address a problem that’s been driving rising prescription drug costs and create a more competitive ...
The FDA is launching a National Priority Voucher program to accelerate reviews of certain new drug applications. The agency will distribute a limited number of vouchers in the program’s first year to ...
Ziftomenib targets relapsed/refractory AML with NPM1 mutations, a condition with high relapse rates and poor survival outcomes. The drug has received breakthrough therapy, fast track, and orphan drug ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for ...
MALMÖ, SE / ACCESS Newswire / September 3, 2025 / Ascelia Pharma AB (publ) (ticker:ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the ...
Please provide your email address to receive an email when new articles are posted on . The single inhaler includes an inhaled corticosteroid, a long-acting beta-agonist and an anticholinergic. The ...
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 ...
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