Showing 6081-6090 of 8899 results for "".
- FDA Accepts Allergan's sNDA for TEFLARO Use in Childrenhttps://practicaldermatology.com/news/fda-accepts-allergans-snda-for-teflaro-use-in-children/2458700/The U.S. Food and Drug Administration (FDA) has accepted Allergan’s supplemental New Drug Application (sNDA) for IV antibacterial TEFLARO® (ceftaroline fosamil). If approved, this filing will expand the label of TEFLARO beyond adults to include children two months of age a
- Cipher's Sitavig Accepted for Review by Health Canadahttps://practicaldermatology.com/news/ciphers-sitavig-accepted-for-review-by-health-canada/2458701/Cipher Pharmaceuticals Inc.’s New Drug Submission for Sitavig has been accepted for review by Health Canada. Sitavig (acyclovir mucoadhesive buccal tablets) is proposed for the treatment of recurrent herpes labialis in adults. In the United States, Sitavig® is approve
- Phase 3 Data for BF-200 ALA Presented at the 14th South Beach Symposiumhttps://practicaldermatology.com/news/phase-3-data-for-bf-200-ala-presented-at-the-14th-south-beach-symposium/2458702/Biofrontera AG’s BF-200 ALA plus red light photodynamic therapy (PDT) shows good efficacy for the treatment of actinic keratoses (AK), according to data presented from three pivotal Phase III trials at the 14th Annual South Beach Symposium. The results were presented in a poster (Poster #11
- Biosimilar News: Sandoz Acquires Biosimilar Infliximab In EEA, FDA Panel Urges Approval of Biosimilar Infliximab in UShttps://practicaldermatology.com/news/biosimilar-new-sandoz-acquires-biosimilar-infliximab-in-eea-fda-panel-urges-approval-of-biosimilar-infliximab-in-us/2458705/Two days after a US Food and Drug Administration (FDA) advisory panel voted to recommend approval of the biosimilar form of Remicade (Infliximab), Novartis’ Sandoz unit has acquired rights to develop and commercialize a biosimilar to Remicade® (i
- Traffic-related Air pollution Linked to Facial Lentigeneshttps://practicaldermatology.com/news/traffic-related-air-pollution-linked-to-facial-lentigenes/2458707/High levels of traffic-related air pollution and air pollution-associated gases may increase risk of developing facial lentigenes, new research suggests. "While NO2 exposure is known to be associated with low lung function and lung cancer, the effect o
- Pfizer Outlines Post-Allergan Deal Leadership Team Changeshttps://practicaldermatology.com/news/pfizer-outlines-post-allergan-deal-leadership-team-changes/2458709/Brent Saunders will become President and Chief Operating Officer of the combined Pfizer and Allergan company following the close of the merger deal. In this role, he will over see Pfizer and Allergan’s combined commercial businesses, manufacturing and strategy functions. The c
- Hilary Baldwin, MD, Named Medical Director of ATRChttps://practicaldermatology.com/news/hilary-baldwin-md-named-medical-director-of-atrc/2458710/The newly opened Acne Treatment and Research Center (ATRC) in Morristown, NJ, has tapped Hilary Baldwin, MD, to serve as its medical director. Dr. Baldwin received her BA and MA in biology from Boston Uni
- FDA Awards Tentative Approval for Zenavod to Treat Rosaceahttps://practicaldermatology.com/news/fda-awards-tentative-approval-for-zenavod-to-treat-rosacea/2458711/The FDA awarded Dr. Reddy's Laboratories tentative approval for Zenavod™ (doxycycline) Capsules, 40mg. Zenavod is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. Promius™ Pharma, LLC, t
- Otsuka Licenses Pre-Phase 3 Topical Atopic Dermatitis Treatment to Medimetrikshttps://practicaldermatology.com/news/otsuka-licenses-pre-phase-3-topical-atopic-dermatitis-treatment-to-medimetriks/2458712/Otsuka Pharmaceutical Co., Ltd. and Medimetriks Pharmaceuticals, Inc. have entered into a licensing agreement granting Medimetriks exclusive development, manufacturing and commercialization rights for OPA-15406 in
- Novan Announces Robert A. Ingram as Chairmanhttps://practicaldermatology.com/news/novan-announces-robert-a-ingram-as-chairman/2458716/Novan, Inc. named Robert A. Ingram as Chairman of the Board of Directors of Novan. In addition, Robert Keegan has been appointed to the Board of Directors. The company also announced that it received $32.8 million of net proceeds in a private Mezzanine B financing in December 2015 from it