Jazz Pharmaceuticals’ acquisition of Chimerix brings a drug that could become the first approved therapy for a rare and ...
Shares of Plus Therapeutics, Inc. PSTV were up a whopping 311.4% on March 6 after the company announced that the FDA has ...
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 impact less ...
With orphan drugs typically being high value, the potential risk of stock losses should be a top concern for biotechs looking ...
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 % ...
PrimeC has been given an ‘Orphan Drug’ status by the FDA (Food and Drug Administration) and EMA (European Medicines Agency).
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 ...
EN001, ENCell’s therapy under development for the treatment of Charcot-Marie-Tooth (CMT) disease, has been granted Orphan ...
Plus Therapeutics (PSTV) announces that the U.S. Food and Drug Administration has granted Orphan Drug Designation to Rhenium Obisbemeda for the ...
The European orphan drug market is growing and is already comparable in size and scope to the US market. The European Union ...
However, fresh evidence from the HHS’ watchdog shows the problem is not a pushover FDA. If anything, the problem is a ...
HanAll Biopharma Co., Ltd. (KRX: 009420.KS), a global biopharmaceutical company committed to discovering and developing ...