Showing 3051-3060 of 3415 results for "".
- It's a RAP: Allergan Set to Acquire Solitonhttps://practicaldermatology.com/news/deal-time-allergan-set-to-acquire-soliton/2460801/Allergan Aesthetics is set to acquire Soliton and Resonic, its Rapid Acoustic Pulse device. Resonic recently received U.S. Food and Drug Administration (FDA) 510(k) clearance and is a non-invasive treatment for the short-term improvement in the appearance of cellulite. The ac
- FDA Accepts Amgen's sNDA for Otezla in Mild-to-Moderate PsOhttps://practicaldermatology.com/news/fda-accepts-amgens-snda-for-otezla-in-mild-to-moderate-pso/2460796/FDA has accepted for review the supplemental New Drug Application (sNDA) for Amgen's Otezla® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The FDA has set a PDUFA action date of
- FDA Nod for Modifications to Soliton's Resonic Devicehttps://practicaldermatology.com/news/fda-nod-for-modifications-to-solitons-tattoo-removal-device/2460790/The U.S. Food and Drug Administration granted Soliton, Inc. 510(k) for modifications to its RESONIC device. The RESONIC device utilizes the RAP technology to deliver safe and effective tattoo removal and cellulite treatment and now includes an autoloading cartridge and an
- Natroba Now Approved for Scabies in Adults and Children as Young as Fourhttps://practicaldermatology.com/news/natroba-now-approved-for-scabies-in-adults-and-children-as-young-as-four/2460789/Natroba™ (spinosad) Topical Suspension, 0.9% is now approved as a topical treatment for scabies infestations in adult and pediatric patients four years of age and older. ParaPRO received approval of a supplemental New Dru
- UCB: Bimekizumab PDUFA Date Set for Octoberhttps://practicaldermatology.com/news/ucb-bimekizumab-pdufa-set-for-october/2460787/The FDA's Prescription Drug User Fee Act (PDUFA) date for UCB’s Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis is October 15, 2021, UCB has indicated. In a
- Expert Opinion: Fleshing Out the Role of Biosimilars in Dermatologyhttps://practicaldermatology.com/news/expert-opinion-fleshing-out-the-role-of-biosimilars-in-dermatology/2460742/Two new studies of biosimilars of tumor necrosis factor blockers that are used to treat a number of dermatologic conditions suggest that they are equivalent to their originator drugs, but there may be more involved in making the decision about switching to a biosimilar than lower cost.
- FDA Grants 510(k) Clearance to Chemence Medical’s Exofin Fusion Redesignhttps://practicaldermatology.com/news/fda-grants-510k-clearance-to-chemence-medicals-exofin-fusion-redesign/2460736/The U.S. Federal Drug Administration gave its nod to Chemence Medical’s redesigned exofin fusion skin closure system. Exofin fusion combines a self-adhering flexible mesh strip and a fast-curing 2-octyl cyanoacrylate topical adhesive to close and seal incisions while forming an im
- Differin Celebrates Retinoid Awareness Week with Educational Initiativeshttps://practicaldermatology.com/news/differin-celebrates-retinoid-awareness-week-with-educational-initiatives/2460710/Following the FDA approval of Differin Gel to be sold over the-counter in 2016, Galderma embarked on a journey to educate consumers about retinoids like adapalene. In 2017, Differin launched its first ever Retinoid Education Week to continue to drive awareness. Now in its fourth year, D
- FDA Grants Priority Review of NDA for Incyte’s Ruxolitinib Cream for ADhttps://practicaldermatology.com/news/fda-grants-priority-review-of-nda-for-incytes-ruxolitinib-cream-for-ad/2460702/The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) of Incyte’s ruxolitinib cream for atopic dermatitis (AD) for priority review. The Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2021. Ruxolitinib cream is
- With sNDA, Amgen Seeks Approval for Otezla in Mild-to-Moderate PsOhttps://practicaldermatology.com/news/with-snda-amgen-seeks-approval-for-otezla-in-mild-to-moderate-pso/2460700/Amgen has submitted a supplemental New Drug Application (sNDA) to the FDA for Otezla® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The sNDA is based on data from the Phase 3 ADVANCE trial tha