Moderna, Inc. announced that the FDA has approved Mflusiva (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 years and older. This approval follows… read more.
Arcutis Biotherapeutics announced that the FDA has approved the supplemental New Drug Application (sNDA) to expand the indication for Zoryve (roflumilast) cream 0.3% for the topical treatment of… read more.
Genmab A/S announced that the European Commission (EC) granted marketing authorization for Tepkinly (epcoritamab) in combination with lenalidomide and rituximab (Tepkinly + R2) for the treatment of adult… read more.
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.
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