FDA Approves Engineered Virus Therapy for Treatment-Resistant Advanced Melanoma
The FDA granted accelerated approval to Tudriqev, a genetically modified herpes virus therapy paired with nivolumab, for adults with advanced melanoma that stopped responding to standard immunotherapy.
FDA Issues EUA for Spray to Prevent New World Screwworm in Multiple Species
The FDA issued an Emergency Use Authorization for CLiK Extra wound spray, a topical insect growth regulator that prevents New World screwworm infestations in livestock, camelids, and captive and captured wildlife species.
FDA Issues EUA for Simparica TRIO to Treat New World Screwworm in Dogs
The FDA issued an Emergency Use Authorization for Simparica TRIO, a prescription chewable tablet, to treat New World screwworm infestations in dogs and puppies exposed in affected areas.
FDA Approves First Drug to Treat Full Range of Narcolepsy Type 1 Symptoms
The FDA approved Orzeyful (oveporexton) tablets for narcolepsy type 1 in adults, the first medicine to treat the full range of symptoms by directly restoring the loss of orexin signaling that causes the disease.
FDA Licenses First Freeze-Dried Plasma Product in the U.S.
The FDA licensed Ezplaz Freeze Dried Plasma, the first freeze-dried plasma product licensed in the United States, offering a room-temperature-stable option for adults who need plasma when other plasma products are unavailable.
FDA Selects Dexcom as First Participant in TEMPO Pilot
FDA named Dexcom as the first manufacturer selected for the TEMPO for Digital Health Devices Pilot, a program pairing digital health technology with the CMS ACCESS Model to improve outcomes for people with chronic diseases.
FDA Revokes Orange B, Proposes Removing Citrus Red No. 2
FDA took two actions targeting petroleum-based color additives, revoking Orange B and proposing to revoke Citrus Red No. 2, as it continues efforts to phase out artificial dyes from the U.S. food supply.
FDA Approves Lipfendra, First Oral PCSK9 Inhibitor for High Cholesterol
FDA approves Lipfendra (enlicitide), the first oral PCSK9 inhibitor, as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia including HeFH.
FDA Proposes Rule to Modernize Drug Manufacturing Registration
FDA proposes streamlined registration for distributed drug manufacturers and clarifies foreign facility requirements under the PREVENT Pandemics Act.
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