Near-term applications include combinations with kinase inhibitors (KIs)that achieve enhanced concentration at target sites ...
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 ...
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the completion of the submission of its New Drug ...
Silo Pharma, Inc. (Nasdaq: SILO) ('Silo” or 'the Company), a diversified developmental-stage biopharmaceutical and ...
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Celcuity submits gedatolisib new drug application to the FDA
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 ...
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 ...
Shanghai Fosun Pharmaceutical (Group) Co ( (HK:2196) ) has shared an announcement.
Lonza helps biotech firms accelerate from DNA to IND with tailored strategies that reduce risk and speed complex biologics to ...
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 ...
Experimental pill versions of GLP-1 weight loss drugs by Novo Nordisk and Eli Lilly will receive FDA priority review. Read ...
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