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 ...

SHELTON, CONNECTICUT / ACCESS Newswire / November 10, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”) today ...

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

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 ...

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.

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 ...

Q3 2025 Earnings Call November 17, 2025 8:30 AM ESTCompany ParticipantsMatthew Duffy - Chief Business Officer & ...

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 ...

November 17, 2025 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the fiscal quarter ending September 30, 2025 with the ...

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

SHELTON, CONNECTICUT / ACCESS Newswire / November 12, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the “Company”), today ...

Earlier this year, researchers at Children's Hospital of Philadelphia and Penn created a first-of-its-kind drug customized to ...