The orphan drug regulations at 21 CFR 316 make no mention of an expedited approval process for orphan drugs. "In other words, the standard of approval for orphan drugs is legally the same as the ...
US regulators have finalized a regulation they say makes some relatively minor changes to the orphan drug regulations and largely, but not entirely, finalizes the regulations as released in October ...
In legislation enacted on Feb. 3, 2026, Congress reauthorized the rare pediatric disease priority review voucher program, clarified the scope of orphan drug exclusivity (ODE) and mandated increased ...
Last week, Congress enacted the Consolidated Appropriations Act of 2026. This legislation narrows the scope of the statutory protection for drugs for rare diseases and conditions under the Orphan Drug ...
Republican Sen. Chuck Grassley, chairman of the Senate Judiciary Committee, has opened an inquiry into potential abuses of the Orphan Drug Act that may have contributed to high prices on commonly used ...
The FDA granted orphan drug designation and fast track designation to Lacripep, according to a press release from ...
Designation provides regulatory and development incentives in Japan, including up to 10 years of market exclusivity upon approval--Follows ...
BOSTON--(BUSINESS WIRE)--PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the “Company”), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming ...
TearSolutions, Inc. has announced that the FDA has granted both Orphan Drug Designation (ODD) and Fast Track Designation for ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results