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 has approved Otsuka's injectable drug to treat patients with a potentially ...
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, ...
Pregnant people have a higher risk of severe disease and death from COVID, so making it harder for them to get vaccinated ...
The FDA’s top vaccine regulator outlines proposed changes to the vaccine evaluation process in an internal memo.
A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging ...
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 ...
The U.S. Food and Drug Administration's newly appointed head of the drug evaluation department, Richard Pazdur, is set to ...
The test confirms the scientific validity of the biomarkers used in the lab, led by researcher Carleara Weiss, and increases ...
The Trump administration is casting more doubt on the safety of vaccines, with an internal memo from the Food and Drug ...
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PDS Biotech Announces Scheduling of Type C Meeting with U.S. Food and Drug Administration (“FDA”)
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 ...
Richard Pazdur, the US Food and Drug Administration’s lead drug regulator, plans to retire from the agency only weeks after ...
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