"Cellenkos gains FDA orphan drug status for CK0804 to treat myelofibrosis" was originally created and published by ...
Less than two weeks after rejecting Sanofi’s investigational multiple sclerosis drug, the FDA has publicly shared the ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight.
Wearable health devices may soon operate under looser regulatory oversight following new guidance from the FDA ...
The FDA has granted breakthrough therapy designation to privosegtor for optic neuritis, a common symptom of multiple ...
These technologies are improving all the time. If they’re not making claims that they are medical grade, let’s let the market ...
The U.S. Food and Drug Administration has approved Myqorzo (aficamten) for the treatment of adults with symptomatic ...
FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical ...
SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / January 2, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar”) today announced that it received notice from the U.S. Food and Drug Administration’s Center ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently ...
By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...
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