The USFDA approved the abbreviated new drug application for Doxorubicin Hydrochloride Liposome injection and single-dose ...

The move comes after the company submitted a new drug application to the Food and Drug Administration for its plant-based ...

Perspective from Lynda Mitchell, MA, CAE The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating anaphylaxis and other type 1 ...

While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...

The U.S. FDA is launching a program under which its commissioner can issue vouchers to companies he finds are aligned with ...

Aldeyra had received 2 complete response letters (CRL) from the FDA in April 2025 and November 2023 for past submissions.

Revuforj is designed to treat patients with relapsed or refractory mutant NPM1 acute myeloid leukemia. The application has been assigned a real-time oncology review, which allows for a more efficient ...

The program will bring together experts from across the FDA for a team-based review, rather than having an application move ...

Novo Nordisk NOVO.B0.48%increase; green up pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense ...

NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with ...

The investigational MRI contrast agent, gadoquatrane, is designed to deliver effective imaging at a significantly reduced ...

Ideally, the approval of a new drug should be exclusively the province of science, but for a more than half-trillion-dollar-a-year industry, it couldn't possibly remain so. The same libertarian ...