The FDA’s top vaccine regulator outlines proposed changes to the vaccine evaluation process in an internal memo.
A major breakthrough in the treatment of an aggressive form of leukemia is bringing new hope to patients and it started in ...
Pregnant people have a higher risk of severe disease and death from COVID, so making it harder for them to get vaccinated ...
The U.S. Food and Drug Administration's newly appointed head of the drug evaluation department, Richard Pazdur, is set to ...
The U.S. Food and Drug Administration has approved Otsuka's injectable drug to treat patients with a potentially ...
The Trump administration is casting more doubt on the safety of vaccines, with an internal memo from the Food and Drug ...
12h
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 ...
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.
The U.S. Food and Drug Administration (FDA) has approved Armlupeg (pegfilgrastim-unne) 6 milligrams per 0.6 milliliter (mg/mL ...
Jaguar’s requesting advice from EMA on EU approval pathway for general diarrhea of FDA conditionally approved Canalevia® A ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback