Remove Clinical Development Remove FDA Remove Licensing
article thumbnail

Actithera draws new investors to radiopharma drug pitch

BioPharma Drive: Drug Pricing

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Actithera draws new investors to radiopharma drug pitch The four-year-old biotech raised about $75 million in a Series A round that involved nine venture capital firms.

Drugs 155
article thumbnail

Navigating Regulatory Hurdles in Drug Development

DrugBank

Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Leniolisib

New Drug Approvals

5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] 5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] Jump up to: a b c d e f g h i j “FDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome” U.S.

article thumbnail

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

BioPharma Drive: Drug Pricing

Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. You can unsubscribe at anytime. © 2025 TechTarget, Inc. or its subsidiaries.

FDA 270
article thumbnail

FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

The Pharma Data

FDA Grants Priority Review to Merck’s WINREVAIR™ Based on Landmark ZENITH Trial Showing Dramatic Reduction in Morbidity and Mortality in PAH Patients Merck (NYSE: MRK), operating as MSD outside the U.S. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025.

Trials 52
article thumbnail

Targeting HER3 – a little wave of drug development that’s about to get a lot bigger

SugarCone Biotech

Reporting in Nature Reviews Drug Discovery, @AsherMullard noted that Merus must provide the FDA with confirmatory evidence of benefit in both NSCLC and pancreatic adenocarcinoma in order to achieve full approval and that analysts predict annual sales of around $180 million by 2030 per consensus forecast via Cortellis.

article thumbnail

Soleno sales of new Prader-Willi drug rise faster than expected

BioPharma Drive: Drug Pricing

Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. You can unsubscribe at anytime. Condulis, for instance, predicts Vykat could reach $2.5 billion in worldwide yearly sales at its peak.

Drugs 243