Latest News - FDA Approval/Clearance

Monday, March 11, 2019

FDA Approves Dupixent for Moderate to Severe AD in Adolescents

The FDA has approved expanded use of Regeneron Pharmaceuticals Inc and Sanofi SA's eczema drug Dupixent to include patients aged 12 through 17 whose disease is not adequately controlled with topic…

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Wednesday, February 27, 2019

FDA Approves Janssen's Tremfya One-Press

The FDA has approved Tremfya® One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis. Tremfya®(guselkumab) from the Janssen Pharmaceutic…

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Monday, February 25, 2019

FDA Proposes New Sunscreen Regulations; Experts React

The FDA is updating its position on over-the-counter sunscreens, and according to the new proposal, several popular ingredients require more data. New guidelines do, however, note that zinc oxide…

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Friday, February 15, 2019

FDA Proposes Policy for New Competitive Generic Therapies Pathway

The FDA has issued a new policy it says is intended to improve access and increase competition for drugs that lack generic competition.  The new pathway for Competitive Generic Therapies (CGTs…

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Tuesday, February 12, 2019

Lutronic Genius RF Microneedling Platform Cleared by FDA

Lutronic has received FDA clearance of the Lutronic Genius™ platform for radiofrequency microneedling. The company says the device transmits energy more precisely into the skin.   …

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Saturday, February 02, 2019

Jeuveau from Evolus Now FDA Cleared for Aesthetic Injection

The FDA has approved Jeuveau™ (prabotulinumtoxinA-xvfs), the lead product from Evolus, Inc., for the temporary improvement in the appearance of moderate to severe glabellar lines associated with…

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Tuesday, November 06, 2018

US FDA Grants Dupixent Priority Review for Moderate-to-Severe AD in Adolescents

The US Food and Drug Administration (FDA) has granted Priority Review for Dupixent (dupilumab) as a potential treatment for adolescents with uncontrolled moderate-to-severe atopic dermatitis (AD). …

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Monday, November 05, 2018

FDA Approves Galderma’s Restylane Lyft for Midface Injection Via Cannula

The U.S. Food and Drug Administration (FDA) has approved the use of Galderma’s Restylane Lyft with a small, blunt-tip cannula for cheek augmentation and the correction of age-related midface con…

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Thursday, October 11, 2018

Study: Positive Safety and Tolerability Results for Ortho Dermatologics' Altreno for Acne

Ortho Dermatologics shared results of two identical Phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel group studies examining the efficacy and safety of Altreno (tretinoin) …

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Monday, October 08, 2018

Ortho Dermatologics Receives Tentative FDA Approval for Bryhali for Plaque Psoriasis

The FDA has provided tentative approval of the New Drug Application for Bryhali (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients. Bryhali Lotion …

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Wednesday, October 03, 2018

FDA Approves Paratek's Nuzyra

The FDA has approved Paratek Pharmaceuticals, Inc's Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infection…

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Wednesday, October 03, 2018

Dermira’s Qbrexa Cloth Now Available for Primary Axillary Hyperhidrosis

Dermira, Inc.'s Qbrexa (glycopyrronium) cloth is now available for prescribing to treat primary axillary hyperhidrosis. The new therapy is available in retail and community pharmacies nationwide. …

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Tuesday, October 02, 2018

Seysara: Oral Antibiotic is First Approved for Dermatology in 40 Years

Seysara (sarecycline), a new, first in class tetracycline-derived oral antibiotic, is now approved for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients…

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Friday, September 28, 2018

FDA Approves Regeneron's Libtayo, First Treatment for Metastatic or Locally Advanced SCC

Libtayo (cemiplimab-rwlc) injection (Regeneron Pharmaceuticals, Inc.)  is now FDA-approved for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma…

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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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