Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026If approved, ZORYVE cream 0.3% would be the first and only topical ...

This NDA submission is an important milestone, and it brings gedatolisib one step closer to becoming available for patients with HR+/HER2- advanced breast cancer,” said Brian Sullivan, CEO and ...

Medicus Pharma shares were 13% higher, at $2.49, after the company said it has submitted a Food and Drug Administration Commissioner's national priority-voucher application on behalf of its Skinject ...

Celcuity (CELC) announced the completion of the submission of its new drug application to the FDA for gedatolisib in hormone receptor positive, ...

Garching / Munich, Germany, November 13, 2025 – (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) completed its filing review and ...

The sNDA was supported by data from a 4 week MUSE study and a long-term open-label study in children aged 2 to 5 years.

One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth ...

Silo Pharma, Inc. (Nasdaq: SILO) ('Silo” or 'the Company), a diversified developmental-stage biopharmaceutical and ...

Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient ...

The “plausible mechanism pathway” will allow personalised drugs to reach the market sooner for patients with genetic diseases ...

Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and ...

KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform ...