A major breakthrough in the treatment of an aggressive form of leukemia is bringing new hope to patients and it started in ...

The U.S. Food and Drug Administration's newly appointed head of the drug evaluation department, Richard Pazdur, is set to ...

Company to Discuss Proposed Amendment to Phase 3 VERSATILE-003 Trial Enabling Potential Accelerated Approval PathwayPRINCETON, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation ...

In March 2025, the FDA approved OMLYCLO in 75 mg/0.5 mL and 150 mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection for the treatment of moderate to severe persistent asthma, ...

Amneal Pharmaceuticals received Food and Drug Administration approval for its albuterol sulfate inhalation aerosol to treat bronchospasm in people with reversible obstructive airway disease. The ...

FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is 'substantially complete” and received for review.

Jaguar’s requesting advice from EMA on EU approval pathway for general diarrhea of FDA conditionally approved Canalevia® A ...

The FDA plans to impose stricter vaccine approval rules, prompting warnings from Georgia doctors who fear the policy could ...

The U.S. Food and Drug Administration has approved Padcev (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug ...

ESTERO, FLORIDA / ACCESS Newswire / December 2, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) (“Aspire” or the “Company”), a developer of a multi-faceted patent-pending drug delivery technology ...

A new type of lens approved by the FDA promises to slow nearsightedness in children and reduce the progression of myopia in ...

Richard Pazdur, the US Food and Drug Administration’s lead drug regulator, plans to retire from the agency only weeks after ...