Takeda announced that the FDA approved Orzeyful (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.*… read more.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved remibrutinib (Rhapsido) 25 mg film-coated tablets for the treatment of adults with chronic spontaneous urticaria (CSU) whose symptoms… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product MenQuadfi…. read more.
Incyte announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura… read more.
Eli Lilly and Company announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib), a… read more.
According to the CHMP/EMA website, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.
Nurix Therapeutics, Inc. announced the closing of its previously announced global collaboration agreement with Roche to co-develop and co-commercialize bexobrutideg, following expiration of the waiting period under the… read more.
Zevra Therapeutics announced the publication of “Arimoclomol in infants with Niemann-Pick disease type C: Results from the phase 2/3 open-label pediatric substudy” in Molecular Genetics and Metabolism Reports…. read more.
According to the EMA website, on 23 July 2026, the CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lynavoy, intended… read more.
Johnson & Johnson announced that the FDA has granted De Novo authorization for the OTTAVA Robotic Surgical System, the world’s first table-integrated soft tissue robotic system. The system… read more.
Viatris Inc. announced that the FDA has approved Gwyn Lo (norelgestromin and ethinyl estradiol transdermal system). Gwyn Lo is a new combined hormonal contraceptive patch with low-dose estrogen…. read more.
BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration has accepted the company’s supplemental New Drug Application for Voxzogo (vosoritide) for full approval in children with… read more.
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