Showing 781-790 of 1556 results for "".
- FDA Grants Breakthrough Status to AD Drug Dupilumabhttps://practicaldermatology.com/news/20141121-fda_grants_breakthrough_status_to_ad_drug_dupilumab/2459056/The FDA has awarded breakthrough therapy designation to the investigational drug dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who had an insufficient response to and/or who are not suitable for topical prescription therapy. Dupilumab blocks IL-4 and IL-13, whi
- FDA Accepts Investigational New Drug Application for Alphaeon's Neurotoxin Evosyalhttps://practicaldermatology.com/news/20140909-fda_accepts_investigational_new_drug_application_for_alphaeons_neurotoxin_evosyal/2459123/The FDA accepted the Investigational New Drug (IND) Application to conduct clinical studies for EVOSYAL, an botulinum toxin Type A neurotoxin that was acquired by Alphaeon last year as part of the acquisition of Evolus Inc. “The product development team
- Novan's Nitric Oxide Drug Candidate Inhibits Growth of Papillomavirus in Translational Animal Model: Presentationhttps://practicaldermatology.com/news/20140909-novans_nitric_oxide_drug_candidate_inhibits_growth_of_papillomavirus_in_translational_animal_model_presentation/2459124/Novan Therapeutics, a clinical-stage biotech company focused on advancing nitric oxide therapies, announced that Novan's nitric oxide drug candidate SB206 was shown to inhibit papilloma growth in a preclinical animal study. About two-thirds of healthy American adults are infected with human papillom
- KYTHERA Biopharmaceuticals Announces FDA Acceptance of ATX-101 New Drug Applicationhttps://practicaldermatology.com/news/20140711-kythera_biopharmaceuticals_announces_fda_acceptance_of_atx-101_new_drug_application/2459173/KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today announced that its New Drug Application (NDA) for ATX-101 (deoxycholic acid) has been accepted for filing by the U.S. Food and Drug Administration (FDA). The acceptance of the NDA reflects the FDA's determination that the application is sufficien
- FDA Grants Orphan Drug Designation for Galderma's Trifarotene Molecule to Treat Congenital Ichthyosishttps://practicaldermatology.com/news/20140702-fda_grants_orphan_drug_designation_for_galdermas_trifarotene_molecule_to_treat_congenital_ichthyosis/2459180/The FDA granted orphan drug designation status for Galderma's trifarotene molecule for the treatment of congenital ichthyosis. Based on this decision, Galderma says it pla
- Aldeyra Therapeutics' Lead Candidate NS2 Shows Novel Approach to Treating Dry Skin, Eye Diseaseshttps://practicaldermatology.com/news/20140512-aldeyra_therapeutics_lead_candidate_ns2_shows_novel_approach_to_treating_dry_skin_eye_diseases/2459242/Aldeyra Therapeutics' lead candidate NS2 decreases aldehyde levels in dry skin and eye models, according to data to be presented as an abstract poster at the Society for Investigative Dermatology (SID) 2014 Annual Meeting, in Albuquerque, NM. The study found that topical applicat
- XOMA Gains Orphan Drug Designation to Treat Pyoderma Gangrenosumhttps://practicaldermatology.com/news/20140225-xoma_gains_orphan_drug_designation_to_treat_pyoderma_gangrenosum/2459332/The FDA approved XOMA Corporation's IL-1 beta antibody gevokizumab for the treatment of pyoderma gangrenosum (PG) under an orphan drug designation. PG is a rare disorder of expanding, painful skin ulcers, which affects one in about 100,000 people. "Selecting pyoderma gangrenosum as our n
- Speedier Drug Approvals Not Tied to Increased Warnings or Health Riskshttps://practicaldermatology.com/news/20130815-speedier_drug_approvals_not_tied_to_increased_warnings_or_health_risks/2459478/Faster drug approvals in the US and Canada are not linked to increases in the number of serious drug safety warnings issued by regulators, nor to actual evidence of health risks, according to new research. Investigators compared data about the number of drug safety warnings issued by regulators in t
- Two Melanoma Drugs Win FDA Approvalhttps://practicaldermatology.com/news/20130530-two_melanoma_drugs_win_fda_approval/2459528/The FDA approved two new drugs for metastatic or inoperable melanoma, dabrafenib (Tafinlar) and trametinib (Mekinist). Dabrafenib is an inhibitor of the BRAF gene when it carries the so-called V600E mutation. Trametinib inhibits a target known as MEK and is effective primarily against melanomas carr
- Court: Off-label Drug Promotion Is Protected Speechhttps://practicaldermatology.com/news/20121204-court_off-label_drug_promotion_is_protected_speech/2459665/The 2nd US Circuit Court of Appeals in New York voted 2-1 to overturn a pharmaceutical salesman's conviction for off-label drug marketing, citing violations against his free speech rights under the First Amendment. The ruling could threaten FDA rules that prevent the marketing of treatments for uses