SolaranRx announced it has received orphan drug designation from the FDA for SRX-1177, its product for treating stage IIB to IV malignant melanoma.
Regulatory
FDA grants orphan drug designation to Samcyprone for malignant stage IIb to IV melanoma
RXi Pharmaceuticals announced it has received orphan drug designation from the FDA for Samcyprone, its clinical candidate for treating malignant melanoma stage IIb to IV.
FDA Grants AstraZeneca’s Selumetinib Orphan Drug Status for Treatment of Uveal Melanoma –Update
AstraZeneca PLC’s (AZN.LN) selumetinib drug has been granted a special status by the U.S. Food and Drug Administration for treatment of Uveal melanoma, a rare eye disease.
FDA to Review Bristol’s Yervoy for Stage 3 Melanoma
The U.S. Food and Drug Administration (FDA) has received the supplemental Biologics License Application (sBLA) submitted by Bristol-Myers Squibb Company for filing and revision of the company’s Yervoy. The medicinal product was designed as an adjuvant therapy for patients who suffer from stage 3 melanoma and are particularly at risk of recurrence after a resection surgical procedure.