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Results For "US-FDA"

344 News Found

Novo Nordisk weathers pricing pressure, bets big on oral Wegovy
News | February 05, 2026

Novo Nordisk weathers pricing pressure, bets big on oral Wegovy

Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates


AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer
News | February 05, 2026

AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)


FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus
Drug Approval | February 05, 2026

FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus

A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available


Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy
News | February 04, 2026

Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy

N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway


Shilpa Medicare & mAbTree Biologics win FDA nod for rare blood cancer therapy
Drug Approval | January 30, 2026

Shilpa Medicare & mAbTree Biologics win FDA nod for rare blood cancer therapy

The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options


Insilico Medicine’s AI-designed Parkinson’s drug cleared for human trials by FDA
Clinical Trials | January 29, 2026

Insilico Medicine’s AI-designed Parkinson’s drug cleared for human trials by FDA

The upcoming Phase I trial will test the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers and determine the optimal dosing for future studies


Truvian Health bags FDA clearance for CBC on TruVerus System
Drug Approval | January 28, 2026

Truvian Health bags FDA clearance for CBC on TruVerus System

TruVerus is the only FDA cleared, multi-modal platform capable of delivering comprehensive routine testing from a single lithium heparin sample


FDA nod to Boehringer Ingelheim's heart disease treatment for dogs 'Vetmedin'
Drug Approval | January 23, 2026

FDA nod to Boehringer Ingelheim's heart disease treatment for dogs 'Vetmedin'

VETMEDIN (pimobendan) chewable tablets and VETMEDIN solution (pimobendan oral solution) can delay the onset of congestive heart failure (CHF) in dogs


iRegene’s Parkinson’s therapy gains FDA designation
News | January 21, 2026

iRegene’s Parkinson’s therapy gains FDA designation

The RMAT designation accelerates the development of regenerative medicine therapies for serious or life-threatening diseases


FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer
Drug Approval | January 21, 2026

FDA go ahead for Eli Lilly’s therapy for hard-to-treat ovarian cancer

Sofetabart mipitecan is a novel folate receptor alpha (FR?) antibody-drug conjugate (ADC) leveraging proprietary linker technology and an exatecan payload to target tumor cells