News

NanoViricides Measles Drug Development Animal Study is Imminent
SHELTON, CT / ACCESS Newswire / June 4, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the “Company ...
The New Rational FDA COVID Vaccine Policy is Long Overdue, Says NanoViricides’ Dr. Diwan
SHELTON, CT / ACCESS Newswire / May 22, 2025 / Dr. Anil Diwan, President of NanoViricides, Inc. (NYSE Amer.:NNVC ) (the ...
BioSpace1d
Kura Posts New Data, Secures NDA Acceptance in Acute Myeloid Leukemia Race With Syndax
Kura Oncology won FDA priority review for its drug the day before announcing new data at ASCO 2025 showing remission in about ...
MPR5d
Drug-Device Combo Therapy Under Review for Parkinson Disease
ND0612 is an investigational drug-device therapy that provides a 24-hour continuous subcutaneous infusion of levodopa/carbidopa solution. The Food and Drug Administration (FDA) has accepted for review ...
Wall Street Journal1mon
Novo Nordisk Says FDA Accepted New Drug Application for Wegovy Pill
Novo Nordisk NOVO.B-2.41%decrease; red down pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a ...
PharmExec13d
FDA Clears Investigational New Drug Application for Ascletis’ Oral IL-17 Inhibitor in Mild-to-Moderate Plaque Psoriasis
Clearance of ASC50 paves the way for a Phase I trial in patients with mild-to-moderate plaque psoriasis.
Nasdaq21d
Unicycive Therapeutics Announces FDA Review of Oxylanthanum Carbonate New Drug Application for Hyperphosphatemia Treatment with PDUFA Action Date of June 28, 2025
Unicycive Therapeutics, Inc. has announced that the FDA is reviewing its New Drug Application for oxylanthanum carbonate (OLC), intended to treat hyperphosphatemia in chronic kidney disease ...
Healio2mon
FDA does not approve resubmitted new drug application for reproxalap
Aldeyra plans to resubmit the new drug application with new trial data later this year. Perspective from Darrell E. White, MD The FDA issued a complete response letter for the resubmission of the ...
MarketWatch2mon
Telix Pharmaceuticals' New Drug Application for Prostate Imaging Drug Gets FDA Approval
Telix Pharmaceuticals' said its new drug application in the U.S. for an imaging agent received regulatory approval. The Melbrourne, Australia-based biopharmaceutical company said Friday that the ...
Becker's ASC2mon
FDA advances new drug application for ketamine
Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June ... “I am very pleased with the new FDA approval goal date of June 4, 2025, for our Ketamine ...
Cure Today1mon
Ziftomenib Submits New Drug Application to FDA for R/R NPM1-Mutant AML
The FDA previously granted breakthrough therapy designation to ziftomenib for relapsed/refractory NPM1-mutant AML. A New Drug Application (NDA) has been submitted to the Food and Drug Administration ...
Morningstar3mon
scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX® Indication to Include the Treatment of Edema in Patients with Chronic ...
FDA approves scPharmaceuticals’ supplemental New Drug Application to expand the FUROSCIX indication to include the treatment of edema in adult patients with chronic kidney disease, including ...