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, ...

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.

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 ...

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

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

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 ...

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

OBI-902, targeting TROP2, gains FDA orphan drug status for cholangiocarcinoma, a rare cancer with poor prognosis and limited treatments. Orphan drug designation provides benefits like tax credits 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 ...