NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)
Label expansion for CIBINQO provides new systemic oral option for adolescents (12 to <18 years) with moderate-to-severe atopic dermatitis
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV
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In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2020
The results mark a potential breakthrough for patients living with CIndU, a condition with limited treatment options
If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US
This marks the second indication for which gumokimab has gained NDA review acceptance
Vanda strongly disputes the FDA’s reasoning
Patients with BRCA mutations often face aggressive disease and poor prognosis
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