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 ...

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

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 ...

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

Evotec SE ( EVO) on Wednesday said that it has received a $5 million milestone payment from Bristol Myers Squibb ( BMY ), following the acceptance of an investigational new drug application by the U.S ...

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

FDA grants Fast Track designation to DPTX3186, Dewpoint’s first in class condensate modulator for gastric cancerDesignation ...