Latest News - Phase 3/4 Trials

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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Monday, September 17, 2018

UCB: Study Data for Cimzia and Bimekizumab Presented at EADV

UCB has presented new findings on Cimzia® (certolizumab pegol) and one of its key pipeline molecules, bimekizumab, for the treatment of moderate-to-severe chronic plaque psoriasis (PSO), along wit…

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Wednesday, September 12, 2018

Foamix: Positive Topline Phase 3 Results for Topical Minocycline Foam

Foamix Pharmaceuticals’ FMX101 topical minocycline foam for the treatment of moderate-to-severe acne has met primary endpoints of its third Phase 3 clinical trial. Foamix shared topline resul…

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Tuesday, August 21, 2018

MC2 Therapeutics Reports Positive Topline Data for Investigational Topical for Psoriasis

MC2-01 Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) from MC2 Therapeutics A/S achieved its primary and secondary endpoints, according to recently reported top-line data from…

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Thursday, July 26, 2018

Almirall: Phase 3 Studies of KX2-391 for AK Meet Primary Endpoints

Both Phase 3 studies of KX2-391met the primary endpoint of complete clearance of actinic keratosis (AK) lesions at day 57 within the face or scalp treatment areas, Almirall, SA reports. Each study ach…

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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 08, 2018

PellePharm Presents New Data in BCC

PellePharm, a late clinical-stage biopharmaceutical company committed to targeting rare dermatologic conditions at their source, presented new data from its clinical and scientific research programs a…

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Friday, June 08, 2018

Opdivo Data: Superior Recurrence-Free Survival Versus Ipilimumab

Updated results from the Phase 3 CheckMate -238 trial evaluating Opdivo (nivolumab, Bristol-Myers Squibb Company) versus Yervoy (ipilimumab, Bristol-Myers Squibb Company) …

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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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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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Thursday, February 15, 2018

Lilly: New Taltz Data and Pipeline Update to be Presented at AAD Annual Meeting

Eli Lilly and Company will present new data for Taltz® (ixekizumab), baricitinib, and mirikizumab at the American Academy of Dermatology (AAD) annual meeting in San Diego. The data include…

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Monday, February 12, 2018

Denova Research and Illinois Dermatology Institute Partner for Clinical Research

DeNova Research is partnering with Illinois Dermatology Institute to become one of the largest and most comprehensive Dermatologic and Cosmetic Clinical Research sites in the Midwest. Denova Resear…

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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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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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Tuesday, December 19, 2017

Biofrontera Files Investigational NDA for Phase 3 Trial of Ameluz for BCC

Biofrontera AG has filed an investigational new drug (IND) application with the FDA for its proposed Phase 3 study protocol to evaluate Ameluz® photodynamic therapy (PDT) for the treatment of supe…

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