Tag Archives: Approves

FDA Approves Wynzora Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%) for Adults with Plaque Psoriasis

FDA Approves Wynzora Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%) for Adults with Plaque Psoriasis Print this page COPENHAGEN, Denmark, July 22, 2020 / B3C newswire / — MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced today that the U.S. Food and Drug Administration… Read More »

FDA Approves Qwo (collagenase clostridium histolyticum-aaes) as the First Injectable Treatment for Cellulite

FDA Approves Qwo (collagenase clostridium histolyticum-aaes) as the First Injectable Treatment for Cellulite Print this page DUBLIN, July 6, 2020 /PRNewswire/ — Endo International plc (NASDAQ: ENDP) today announced that it received U.S. Food and Drug Administration (FDA) approval of Qwo (collagenase clostridium histolyticum-aaes) for the treatment of moderate to severe cellulite in the buttocks… Read More »

FDA Approves Gimoti (metoclopramide) Nasal Spray for Diabetic Gastroparesis

FDA Approves Gimoti (metoclopramide) Nasal Spray for Diabetic Gastroparesis Print this page SOLANA BEACH, Calif., June 19, 2020 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for… Read More »

FDA Approves New Pediatric Formulation of Sirturo (bedaquiline) as Part of Combination Therapy to Treat Children with Pulmonary Multidrug-Resistant Tuberculosis

Print this page NEW BRUNSWICK, NJ, May 27, 2020 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new pediatric formulation of Sirturo (bedaquiline). Sirturo is now indicated for use as part of combination therapy in the treatment of adult… Read More »

FDA Approves Dupixent (dupilumab) as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis

Print this page TARRYTOWN, N.Y. and PARIS, May 26, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not… Read More »