Latest News - FDA Approval/Clearance

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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Wednesday, March 21, 2018

Sun Pharma: FDA Approves Ilumya for Adult Psoriasis

The FDA has approved Ilumya™ (tildrakizumab-asmn) from Sun Pharma for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Il…

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Friday, March 09, 2018

White Paper: It’s Time to Start Prescribing Biosimilars

The American College of Rheumatology’s new white paper, “The Science Behind Biosimilars -- Entering a New Era of Biologic Therapy,” encourages physicians to begin integrating biosi…

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Thursday, February 08, 2018

FDA Approves Cosentyx Label Update to Include Scalp Psoriasis

The FDA has approved a label update for Novartis' Cosentyx (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis. The updated label inc…

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Monday, January 29, 2018

Abeona Receives FDA Regenerative Medicine Advanced Therapy Designation for EB-101 Gene Therapy in EB

The US Food and Drug Administration (FDA) granted the Regenerative Medicine Advanced Therapy (RMAT) designation to EB-101, Abeona Therapeutics Inc.’s gene-corrected autologous cell therapy produ…

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Thursday, January 04, 2018

FDA Approves BMS's Opdivo as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease

The FDA has approved Bristol-Myers Squibb Company's Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metasta…

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Thursday, January 04, 2018

BioPhotas, Inc. Launches the Newest Model of the Celluma Series

BioPhotas, Inc. launched its Celluma HOME, a fourth model in the Celluma Series of light therapy devices. The company says the Celluma HOME specifically addresses the challenges of Baby Boomers who st…

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Wednesday, December 20, 2017

FDA Accepts NDA for Allergan, Paratek Acne Drug

The U.S. Food and Drug Administration accepted a New Drug Application (NDA) to review SeysaraTM(sarecycline) for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older,…

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Friday, December 15, 2017

SK Breakthrough: FDA Approves Eskata (hydrogen peroxide) Topical Solution from Aclaris

The FDA has approved ESKATA™ (hydrogen peroxide) topical solution, 40% (w/w) from Aclaris Therapeutics, Inc. for the treatment of seborrheic keratoses (SKs). SKs are non-cancerous skin growths t…

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