The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

The inspection concluded with a Form 483 containing several observations. Capricor said it has submitted its responses to the FDA, none of which required material changes to the cGMP process or ...

The FDA has accepted the New Drug Application for ET-600, an oral solution formulation of desmopressin, for the treatment of central diabetes insipidus.

KalVista has become the latest biotech to face delays to FDA decision-making, as the agency blames a “heavy workload” for pushing back a PDUFA date.

FDA assigns PDUFA target action date of January 31, 2026 WARREN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a ...

The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include people 18 to 59 years old who are at increased risk for severe illness from ...

A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug Administration to be used to prevent HIV.

Discover the latest FDA warning updates for COVID vaccines including increased health risks and new restrictions for healthy adults.

FDA approves twice-a-year HIV prevention drug that could help end the virus worldwide It reduces transmissions by up to 96%, but now world governments and big-dollar funders will need to step in.

The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed warnings for cytokine release syndrome and neurological toxicities, and ...

Sprout Pharmaceuticals is once again under fire from the FDA’s Office of Prescription Drug Promotion (OPDP). The OPDP issued a warning letter to the drugmaker—dated May 29 and publicly ...

MARYLAND – The US Food and Drug Administration (FDA) on June 12 expanded the use of Moderna’s respiratory syncytial virus (RSV) vaccine to a younger group of adults aged 18 to 59 who are at ...