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.
RegulatoryFDA 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.
RegulatoryFDA 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.
RegulatoryNew 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.
RegulatoryFDA 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.
RegulatoryFDA 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.
RegulatoryEMA 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.
RegulatoryFirst 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.
RegulatoryECDC Launches New Respiratory Virus Surveillance Guidance
ECDC published new integrated respiratory virus surveillance guidance for the EU/EEA, giving countries a common framework to detect virus circulation changes earlier and strengthen public health decision-making.
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