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The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...
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NDTV Profit on MSNAlembic Pharma Shares Surge After USFDA Nod For New Ovarian Cancer DrugThe USFDA approved the abbreviated new drug application for Doxorubicin Hydrochloride Liposome injection and single-dose ...
Aldeyra had received 2 complete response letters (CRL) from the FDA in April 2025 and November 2023 for past submissions.
While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...
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 ...
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 ...
The U.S. FDA is launching a program under which its commissioner can issue vouchers to companies he finds are aligned with ...
In a Phase I/II clinical trial, TKI-pretreated NSCLC patients given zidesamtinib had an overall response rate of 44 percent.
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 program will bring together experts from across the FDA for a team-based review, rather than having an application move ...
An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...
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