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.
FDAFDA 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.
FDAFDA 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.
FDANew Brazilian Pharmacopeia Publications Come into Force
Four new Brazilian Pharmacopeia publications took effect on July 1, updating the national quality standards for medicines, pharmaceutical inputs, and other products under health surveillance.
ANVISAFDA 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.
FDAFDA 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.
FDAEMA Recommends Susvimo for Neovascular Age-Related Macular Degeneration
EMA recommends Susvimo, an ocular implant that releases ranibizumab over time, as a new treatment option for adults with stable neovascular age-related macular degeneration.
EMAFirst Oral IL-23 Receptor Antagonist Recommended for Plaque Psoriasis
EMA recommends Icotyde (icotrokinra), the first oral medicine targeting the interleukin-23 pathway, for moderate-to-severe plaque psoriasis in adults and adolescents.
EMAFDA 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.
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