Novartis announced the FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic… read more.
AbbVie announced that the EC has approved Rinvoq (upadacitinib; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients 12 years and older… read more.
Novartis announced that the European Commission (EC) has approved Itvisma (onasemnogene abeparvovec) for the treatment of children two years and older, teens and adults living with spinal muscular… read more.
Sanofi announced that the European Commission (EC) has approved an extension of the indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants… read more.
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.
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