Showing 3211-3220 of 5839 results for "".
- Study: FDA Approves Drugs Faster than Europe, Canadahttps://practicaldermatology.com/news/20120517-study_fda_approves_drugs_faster_than_europe_canada/2459797/Drugs are approved faster in the US than in Europe and Canada, new research from Yale University School of Medicine shows. Authors of the study, published in The New England Journal of Medicine, reviewed decisions from 2001 to 2010 by the FDA and regulators in Canada and Europe, Health Canada and th
- FDA Extends Deadline for Sunscreen Label Compliancehttps://practicaldermatology.com/news/20120514-fda_extends_deadline_for_sunscreen_compliance/2459802/Sunscreen manufacturers have won a small victory from the Food and Drug Administration (FDA), which has extended the deadline for compliance with new labeling back to December 2013 for some companies. The industry pushed back on the agency, which ordered changes to sunscreens last summer with an ori
- Retinoid Foam Wins FDA Approvalhttps://practicaldermatology.com/news/20120514-new_retinoid_foam_wins_fda_approval/2459804/The FDA has ap
- New Retinoid Foam Wins FDA Approvalhttps://practicaldermatology.com/news/20120514-new_retinoid_foam_wins_fda_approval/2459805/The FDA has approved Fabior (tazarotene) Foam, 0.1%, for the treatment of acne vulgaris in patients 12 years and older. The approval was based on two multi-center, randomized, double-blind, vehicle-controlled pivotal Phase 3 studies, in which a total of 1,485 patients with moderate-to-severe acne vu
- Provectus Pharmaceuticals' PV-10 Phase 2 Final Data To Be Presentedhttps://practicaldermatology.com/news/20120509-provectus_pharmaceuticals_pv-10_phase_2_final_data_to_be_presented/2459806/Phase 2 final data on PV-10 for metastatic melanoma by Provectus Pharmaceuticals, Inc. (OTCBB: PVCT) will be presented at the second European PostASCO Melanoma Meeting 2012, Interdisciplinary Global Conference on Developing New Treatments for Melanom
- Novartis Acquires Fougera Pharma for $1.5 Billionhttps://practicaldermatology.com/news/20120504-novartis_acquires_fougera_pharma_for_15_billion/2459809/With it's $1.5 billion acquisition of US-based Fougera Pharmaceuticals, Novartis will be the biggest maker of dermatologic generics in the country. The Fougera products will add to those of Novartis's existing generics unit Sandoz.
- Ouchless Needle Announces First Exclusive International Distribution Agreement with Device Technologieshttps://practicaldermatology.com/news/20120501-ouchless_needle_announces_first_exclusive_international_distribution_agreement_with_device_technologies/2459811/Ouchless Needle by the BellaNovus Development Company announced their first international exclusive distribution agreement with Device Technologies for Australia and New Zealand. Developed by aesthetic plastic surgery innovator Marc J. Sa
- FDA Seeks More Information on Pliaglishttps://practicaldermatology.com/news/20120419-fda_seeks_more_information_on_pliaglis/2459818/FDA's Complete Response Letter to Galderma Laboratories LP outlines additional information the FDA requires before it will approve the sNDA for Pliaglis, developer Nuvo Research, Inc. reports. The response is to the supplemental New Drug App
- FDA's 45-day TV ad reviewhttps://practicaldermatology.com/news/20120313-fdas_45-day_tv_ad_review_shot_clock_in_guidance/2459846/TV ads for most prescription drugs must be submitted to FDA for pre-review 45 days before the manufacturer intends to air them, according to an FDA draft guidance in tomorrow's Federal Register. The guidance isn't a bolt from the blue but rather a case of the agency catching up on old business – i
- Cellceutix Files pre-IND Submission for Prurisol for Psoriasishttps://practicaldermatology.com/news/20120312-cellceutix_files_pre-ind_submission_for_prurisol_for_psoriasis/2459849/Cellceutix Corporation (OTCBB: CTIX) filed a pre-IND submission with the FDA for Prurisol (also termed KM-133), a drug in development for treatment of psoriasis. The company is seeking guidance to attain approval for a section 505(b)(2) designa