Latest News - FDA Approval/Clearance

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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Thursday, June 21, 2018

FDA-Approved Label Update: Cosentyx Inhibits Progression of Joint Structural Damage in PsA

The US FDA has approved a label update for Cosentyx® (secukinumab) from Novartis, including data that show the treatment significantly slows the progression of joint structural damage at Week 24 v…

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Wednesday, May 30, 2018

New CFO at Evolus, Inc.

Lauren Silvernail is the new Chief Financial Officer and Executive Vice President, Corporate Development at Evolus, Inc. Silvernail joins Evolus from Revance Therapeutics where she most recently se…

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Tuesday, May 29, 2018

FDA Approves Cimzia for Moderate to Severe Plaque Psoriasis

The FDA has approved extending the label for UCB's Cimzia (certolizumab pegol) to include a new indication in adults with moderate to severe plaque psoriasis. Cimzia is indicated for the treatment…

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Sunday, May 27, 2018

FDA: Pills Don’t Replace Sunscreen

The U.S. Food and Drug Administration (FDA) is cracking down on companies marketing supplements that claim to counter the effects of the sun's ultraviolet rays. These companies -- m…

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Tuesday, May 22, 2018

FDA Approves Lilly's Taltz for Label Update to Treat Psoriasis Involving the Genital Area

The FDA has approved a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area. Eli Lilly and Company's Taltz is the first treatment FDA…

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Monday, May 21, 2018

FDA Greenlights Restylane Lyft for Hand Rejuvenation

The US Food and Drug Administration has approved Restylane Lyft for use on the dorsal hands of people older than 21, making it the first hyaluronic acid (HA) injectable gel approved for this…

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Wednesday, May 16, 2018

Castle Creek Pharmaceuticals Receives FDA Rare Pediatric Disease Designation for Diacerein 1% Ointment for EB

  The FDA has granted rare pediatric disease designation for Castle Creek Pharmaceuticals' (CCP) diacerein 1% ointment (CCP-020) for the treatment of epidermolysis bullosa (EB). The safety an…

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Tuesday, May 01, 2018

FDA Approves Tafinlar + Mekinist for Adjuvant Treatment of BRAF V600-Mutant Melanoma

The FDA has approved Novartis' Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected …

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Friday, April 06, 2018

FDA Approves Sonoma Pharmaceuticals' Antimicrobial Post-Therapy Gel

Sonoma Pharmaceuticals, Inc. has received a new 510(k) clearance from the FDA for an antimicrobial post-therapy gel. Under the supervision of a healthcare professional, the new product is intended for…

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Wednesday, April 04, 2018

GlobalData: Sun Pharma’s Ilumya To Face Strong Competition in the US market

It’s a tough road ahead for Sun Pharma’s newly approved Ilumya, according to a new report from GlobalData, a leading data and analytics company.

 In March 2018 the US Food and Drug…

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Thursday, March 22, 2018

FDA Approves Label Update for Cimzia Addressing Low Risk of Fetal Exposure

The FDA has approved a label update that includes pharmacokinetic data showing negligible to low transfer of Cimzia® (certolizumab pegol) through placenta and minimal transfer to …

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