The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...

The firm said at the JP Morgan Healthcare Conference that it wants zorevunersen to be approved as a disease-modifying ...

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 ...

46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

The FDA has accepted Stealth BioTherapeutics’ new drug application for its ultrarare disease candidate, providing a planned decision date of Sept. 26. The timeline is surprising since the agency ...

Takeda and Protagonist Therapeutics have submitted a new drug application to the FDA for rusfertide for adults with ...

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 ...

MALMÖ, SE / ACCESS Newswire / November 15, 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 ...

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 US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under ...

The U.S. Food and Drug Administration is reviewing a new Parkinson’s disease drug called tavapadon that could give people with the disease more control over their movements. If approved, it would be ...