Patients may report side effects to the FDA at 1-800-FDA-1088. Please click here for the full Prescribing Information, including Patient Information, for JOURNAVX. About Vertex ...
Feb. 5. 2025 – The FDA has approved a new pill to treat adults with a type of blood cancer called mantle cell lymphoma (MCL). This treatment is for people who are newly diagnosed or haven't h ...
FDA Approves Symbravo for Acute Treatment of Migraine in Adults By Lori Solomon HealthDay Reporter WEDNESDAY, Feb. 5, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved ...
announced today that the U.S. Food and Drug Administration (FDA) approved ONAPGO (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine ...
In a significant advancement in hearing and vision solutions, EssilorLuxottica has announced that its Nuance Audio Glasses have gained clearance from the Food and Drug Administration (FDA ...
The Nuance Audio smart glasses designed to help those with hearing loss have gained FDA approval, meaning they can be explicitly sold OTC in the US for that purpose. The EssilorLuxottica brand’s ...
The first transplant is expected in mid-2025. Meanwhile, rival eGenesis said it had received FDA approval in December for a separate three-patient kidney study. "The study will evaluate patients with ...
The U.S. Food and Drug Administration (FDA) has approved the first-ever clinical trials testing pig kidney transplants in people with kidney failure, marking a major step forward in cross-species ...
On its fourth attempt to pass muster with the FDA, the company’s SPN-830, now branded as Onapgo, finally earned the agency’s stamp of approval to treat motor fluctuations in adults with ...
The U.S. Food and Drug Administration (FDA) approved the drug for use in acute pain, but Vertex aims to eventually win approval in chronic pain, too. Clinical trials are ongoing, and the biotech ...
The Food and Drug Administration (FDA) approved Journavx (suzetrigine) on Jan. 30, a first-in-its-class medication that works by blocking pain signals in the peripheral nerves, before they reach the ...
The approval brings to an end the company's years-long effort to secure the FDA's nod. The agency had declined to approve Supernus' application in 2022 and 2024, with the regulator last year ...
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