Latest News - FDA Approval/Clearance

Friday, September 21, 2018

FDA Green Lights First Spray-on-Skin Product for Burns

The US Food and Drug Administration granted premarket approval to Avita Medical’s Recell, a spray-on-skin that treats second- and third-degree burns in patients aged older than 18 years. The …

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Tuesday, September 18, 2018

FDA Clears Sebacia Microparticles for Laser-Based Acne Treatment

Sebacia Microparticles are now FDA-cleared for use in the treatment of acne. The clearance comes on the heels of a pivotal study demonstrating the clinical safety and efficacy of the micoparticles. Se…

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Wednesday, September 05, 2018

New from Thermi: Meet the Arvati Platform

Thermi, an Almirall company, is launching Arvati, a next-generation 510K US Food and Drug Administration-cleared, true temperature-controlled radiofrequency platform that powers a range of Thermi proc…

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Wednesday, August 29, 2018

FDA Accepts Ortho Derm's Resubmission of NDA for Duobrii Lotion for Plaque Psoriasis

The FDA has accepted Ortho Dermatologics' resubmitted New Drug Application (NDA) for Duobrii (halobetasol propionate and tazarotene) (IDP-118) Lotion for the topical treatment of plaque psoriasis.…

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Monday, August 27, 2018

Latest on Compounding: FDA Proposes to Strike Three Bulk Drug Substances from List

The FDA has issued a Federal Register notice proposing not to include three bulk drug substances, bumetanide, nicardipine hydrochloride, and vasopressin, on the list of bulk drug substances …

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Friday, August 24, 2018

FDA Nod for Ortho Derm’s Acne Lotion Altreno

The U.S. Food and Drug Administration (FDA) approved the New Drug Application for Ortho Dermatologic’s Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in p…

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Thursday, August 23, 2018

Lupin Launches Generic Clobetasol Cream in the US

Lupin has launched its Clobetasol Propionate Cream 0.05%, having received approval from the FDA earlier. Lupin's Clobetasol Propionate Cream USP 0.05% is the generic equivalent of Fougera Pharmac…

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Thursday, August 09, 2018

Castle Creek Pharmaceuticals Gets FDA Fast Track Designation for Diacerein 1% Ointment for EBS

The U.S. Food & Drug Administration (FDA) granted fast track status to Castle Creek Pharmaceuticals, LLC’s diacerein 1%, ointment (CCP-020) for the treatment of epidermolysis bullosa simplex…

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Thursday, August 09, 2018

FDA Committee Recommends Approval of Paratek’s Omadacycline

The Antimicrobials Drug Advisory Committee of the FDA voted in favor of the approval of intravenous (IV) and oral omadacycline for the treatment of acute bacterial skin and skin structure infections (…

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Thursday, August 09, 2018

FDA Approves Poteligeo for Cutaneous T-Cell Lymphomas

The FDA approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with two types of cutaneous T-cell lymphoma (CTCL) -- relapsed or refractory mycosis f…

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Tuesday, July 31, 2018

FDA Cracks Down on Energy-Based Vaginal Rejuvenation

The FDA is cracking down on the use energy-based devices to perform vaginal 'rejuvenation.' The use of such devices to perform vaginal "rejuvenation," cosmetic vaginal procedures,…

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Monday, July 16, 2018

New From Candela: Vbeam Prima

Recently FDA-cleared, the Vbeam Prima from Candela offers two wavelengths to effectively treat a broad range of skin conditions including rosacea, spider veins, wrinkles, acne and …

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Monday, July 02, 2018

XELJANZ Receives EU Marketing Authorization for Adults with Active PsA

The European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adul…

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Friday, June 29, 2018

FDA Approves Dermira's Qbrexza Cloth to Treat Primary Axillary Hyperhidrosis

The FDA has approved Qbrexza™ (glycopyrronium) cloth, an anticholinergic indicated for the topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and …

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Wednesday, June 27, 2018

FDA Approves Braftovi in Combination with Mektovi for Advanced BRAF-mutant Melanoma

The FDA has approved Array BioPharma Inc.'s BRAFTOVI (encorafenib) capsules in combination with MEKTOVI (binimetinib) tablets for the treatment of patients with unresectable or metastatic melanoma…

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