Orphan Drug, FDA and Korro
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 ...
Treatments for autoimmune diseases and those in orphan markets are on the up and up, as are drugmakers’ first launches, ...
With orphan drugs typically being high value, the potential risk of stock losses should be a top concern for biotechs looking ...
3d
GlobalData on MSNLundbeck’s amlenetug gains orphan drug status in Japan for MSALundbeck has gained orphan drug designation (ODD) from Japan’s Ministry of Health, Labor and Welfare (MHLW) for amlenetug to ...
The FDA granted fast track designation to ATSN-201 for the treatment of X-linked retinoschisis, according to a press release ...
In 2025, Cellectis will continue to focus its efforts and expenses on advancing its core clinical trials BALLI-01 and NATHALI ...
7d
GlobalData on MSNFDA ODD given to Plus Therapeutics’ injectable radiotherapyThe US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Plus Therapeutics’ injectable ...
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