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TOKYO and NEW YORK — Astellas Pharma Inc. President and CEO Naoki Okamura and Pfizer Inc. today announced that on December 15 the U.S. Food and Drug Administration (FDA) approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate) with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally...
CRANBURY, N.J. — Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced the US Food & Drug Administration (FDA) has granted “orphan drug” designation to PL7737, an oral treatment that activates the melanocortin-4...
WAYNE, Pa. — Palvella Therapeutics Inc., a clinical-stage biopharmaceutical company developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies, and Ligand Pharmaceuticals Inc. (Nasdaq: LGND), a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value...
WAYNE, Pa. – Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced the expansion of its QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin)...
Wayne, Pa. — Palvella Therapeutics, Inc., a late clinical-stage biopharmaceutical company whose vision is to become the leading rare disease company focused on developing and commercializing novel therapies to treat individuals suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies, announced positive topline results from...
WAYNE, Pa. — (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced positive topline results from the...
WAYNE, Pa. — (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced a new product candidate,...
WAYNE, Pa. — (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that the FDA has...
WAYNE, Pa. — (Nasdaq: PVLA) Palvella Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced it has received the second year of funding...
MINNEAPOLIS — Panbela Therapeutics, Inc., a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs announces the publication of clinical data from studies of CPP-1X (also known as α-Difluoromethylornithine (DFMO) or Eflornithine) in neuroblastoma. According to Hogarty et al, children with relapsed...