GSK plc GSK announced that Japan’s Ministry of Health, Labour and Welfare has granted Orphan Drug Designation (ODD) to ...

Sumitomo Pharma America, Inc. (SMPA) today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to its investigational therapy DSP-3077 for the treatment of ...

Orphan designation reflects unmet need in RP rather than evidence of efficacy, while offering development incentives and ...

Japan MHLW grants orphan drug designation to GSK’s B7-H3-targeted antibody-drug conjugate, risvutatug rezetecan to treat small-cell lung cancer: London, UK Tuesday, March 24, 20 ...

Rilzabrutinib is an investigational, oral reversible Bruton tyrosine kinase inhibitor. The Food and Drug Administration (FDA) has granted Orphan Drug designation to rilzabrutinib for the treatment of ...

IRA revisions now exempt multi-indication orphan drugs from price negotiations, improving lifecycle economics and encouraging ...

The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease ...

A GSK treatment for an aggressive form of small-cell lung cancer has been granted orphan drug designation in Japan, the ...

Aug. 1, 2005 — Europe has approved orphan drugs pegylated arginine deiminase for the treatment of hepatocellular carcinoma, soluble yeast beta-1,3/1,6-glucan for the prophylaxis of mucositis due to ...

Report reveals that FDA temperament and blockbuster drugs fall short of disrupting the ever-increasing orphan drug market LONDON – 13 March 2026 – Evaluate, the leading provider of market insights for ...

The legal battle over the scope of orphan drug exclusivity continues, as the U.S. Food and Drug Administration (“FDA”) has recently lost a second case concerning the exclusivity provisions of the ...

June 15, 2007 — The US Food and Drug Administration (FDA) has granted orphan drug designation for leukocyte interleukin as neoadjuvant therapy for patients with squamous cell carcinoma of the head and ...