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Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting ...
As the Trump administration loosens enforcement by the FTC and the FDA of unproven health claims, allies in Robert F. Kennedy ...
IRVINE, CA / ACCESS Newswire / August 20, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) (“enVVeno” or the “Company”), a company setting new standards of care for the treatment of deep venous ...
In June, the monoclonal antibody garadacimab (Andembry) was approved for prevention of HAE attacks at a dose of once monthly ...
UCLA’s cancer research has been deeply impactful, with millions of people receiving drugs and therapies developed in Bruin ...
HC Wainwright backs Achieve Life Sciences with a Buy rating as cytisinicline nears potential 2026 FDA approval, targeting a ...
LASIK is marketed as a simple procedure, but for some, it's anything but. Patients explain the realities of living with dry ...
The FDA has agreed to speed up a review of a rare disease drug developed by Stealth BioTherapeutics, a notable step after the ...
Almost all medicinal cannabis products being used in Australia have not been approved by the federal drug regulator.
August 20, 2025—enVVeno Medical Corporation announced that it has received a not-approvable letter from the FDA in response to its premarket app ...
Regulations aiming to lower the cost of vital medicines will instead end up restricting access and disincentivizing R&D.
Developers Invivyd, Inc. are working on a plan with the FDA that will see their antibody-based product approved if it passes ...