TAMPA, Fla. — Pacira Biosciences Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to PCRX-201 (enekinragene inzadenovec), the company’s novel, intra-articular helper-dependent adenovirus...
treatment News
Edmonton, Canada – Pacylex Pharmaceuticals Inc. (Pacylex) is a clinical-stage pharmaceutical company focused on the development of a new class of targeted therapies, N-myristoyltransferase inhibitors (NMTi) for the treatment of hematologic and solid tumor cancers. Today Pacylex announced that the results of its Phase 1 dose escalation safety and tolerability...
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., 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...