Orphan Drug, FDA and lung cancer

PSTV Stock Skyrockets on FDA's Orphan Drug Tag for Cancer Therapy
Shares of Plus Therapeutics, Inc. PSTV were up a whopping 311.4% on March 6 after the company announced that the FDA has granted an Orphan Drug Designation (“ODD”) to its lead radiotherapeutic candidate,
Plus Therapeutics soars on FDA Orphan Drug Designation for lung cancer treatment
Plus Therapeutics (NASDAQ:PSTV) shares rose 71% after the company said on Thursday that the U.S. FDA has granted Orphan Drug Designation for its treatment of leptomeningeal metastases in lung cancer patients.
Lundbeck's potential treatment for Multiple System Atrophy granted Orphan Drug Designation in Japan
VALBY, Denmark, March 10, 2025 /PRNewswire/ -- The Ministry of Health, Labor, and Welfare (MHLW) in Japan has granted Orphan Drug Designation (ODD) to Lundbeck's investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA).
DiagnaMed Granted FDA Orphan Drug Designation for Molecular Hydrogen to Treat Amyotrophic Lateral Sclerosis
"Receiving orphan drug designation from the FDA is a significant milestone for DiagnaMed and validates the promise of molecular hydrogen as a potential treatment for ALS. We are excited to partner with Revive Therapeutics to advance this program and meet the urgent needs of the ALS community."
FDA Grants Rhenium Obisbemeda Orphan Drug Status for LM in Lung Cancer
The FDA granted orphan drug status to rhenium-186 obisbemeda for treating leptomeningeal metastases in lung cancer.
Drexel University3d
Orphaned Again: Revisiting the Orphan Drug Act and Prioritizing Patient Access to Medicine
In 1983, Congress passed the Orphan Drug Act (“ODA”) as part of an effort to provide market incentives for pharmaceutical manufacturers to produce “orphan drugs,” drugs for diseases that ...
Pharmaceutical Technology4d
Orphan drugs: How to avoid costly stock losses in Europe
With orphan drugs typically being high value, the potential risk of stock losses should be a top concern for biotechs looking ...
PharmiWeb4d
Global Orphan Drug Market Poised for Significant Growth Amid Rising Demand and Regulatory Support
The global orphan drug market size was USD 154.20 Billion in 2022 and is expected to register a rapid revenue CAGR of 12.3 % ...
Medical Device Network4d
Realising the opportunities for growth in the European orphan drug market
The European orphan drug market is growing and is already comparable in size and scope to the US market. The European Union ...
ENCell’s EN001 Receives Orphan Drug Designation from the U.S. FDA for Charcot-Marie-Tooth Disease
EN001, ENCell’s therapy under development for the treatment of Charcot-Marie-Tooth (CMT) disease, has been granted Orphan ...
Plus Therapeutics granted Orphan Drug Designation for Rhenium Obisbemeda
Plus Therapeutics (PSTV) announces that the U.S. Food and Drug Administration has granted Orphan Drug Designation to Rhenium Obisbemeda for the ...
Dealbreaker on MSN2d
First-in-Class Brain Cancer Drug Strikes a Chord With Jazz Pharma to the Tune of a $935M M&A Deal
Jazz Pharmaceuticals’ acquisition of Chimerix brings a drug that could become the first approved therapy for a rare and ...
HanAll Biopharma Announces Orphan Drug Designation for Batoclimab in Japan for Active Thyroid Eye Disease
HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing ...