Daiichi Sankyo and AstraZeneca announced that Datroway (datopotamab deruxtecan) has been approved in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable… read more.
Replimune Group announced that the FDA has granted accelerated approval for TudriqevTM (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of adults… read more.
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.
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.
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.
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.
Otsuka announced that the FDA has granted approval of SIMTRIYO (centanafadine), a once-daily extended-release capsule for the treatment of attention-deficit hyperactivity disorder in adults and pediatric patients aged… read more.
Allergan Aesthetics announced the EC has approved Boey (trenibotulinumtoxinE) in Europe, for the temporary improvement in the appearance of moderate to severe lines between the eyebrows seen at… read more.
NICE (UK): Aficamten can be used as an option to treat symptomatic obstructive hypertrophic cardiomyopathy in adults with a New York Heart Association class of 2 to 3…. read more.
PharmaMar announced that health authorities in Canada, Qatar and South Korea have approved Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) for the maintenance treatment for adult patients with… read more.
The European Medicines Agency’s (EMA) key human medicines committee (CHMP) has recommended twelve medicines for approval at its July 2026 meeting. This brings to 54 the number of… read more.
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