578 Results

Complete Response Letter regarding the New Drug Application (NDA) for DUOBRII (IDP-118) lotion in the treatment of plaque psoriasis. - Ortho Dermatologics/Valeant Pharma.

 Added 3 days ago

Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. announced that it has received a Complete Response Letter (CRL) from...

Motif Bio plc completes rolling submission to FDA for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

 Added 7 days ago

Motif Bio plc has announced the completion of its rolling submission of a New Drug Application (NDA) to the FDA...

FDA accepts sBLA for Gardasil 9 for patients ages 27 to 45 for the prevention of certain cancers and diseases caused by nine human papillomavirus (HPV) types.- Merck Inc.

 Added 8 days ago

Merck Inc., has announced that the FDA has accepted for review a new supplemental Biologics License Application (sBLA) for Gardasil...

Pooled data from REVIVE-1 and REVIVE-2 trials of iclaprim in ABSSSI patients confirms non inferiority to vancomycin.- Motif Bio plc.

 Added 10 days ago

Motif Bio plc has announced that the pooled efficacy and safety data from its two Phase III trials (REVIVE-1 and...

FDA approves Rituxan to treat severe pemphigus vulgaris.- Genentech/Roche.

 Added 13 days ago

Genentech, a member of the Roche Group announced that the FDA has approved Rituxan (rituximab) for the treatment of adults...

NEJM publishes data from cemiplimab trials in advanced cutaneous squamous cell carcinoma .- Sanofi + Regeneron.

 Added 17 days ago

The New England Journal of Medicine (NEJM) published pivotal data from two trials evaluating cemiplimab in advanced cutaneous squamous cell...

FDA approves Imvexxy for treatment of moderate-to-severe dyspareunia.- TherapeuticsMD.

 Added 21 days ago

TherapeuticsMD announced that the FDA has approved Imvexxy (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated...

FDA approves Cimzia for moderate-to-severe plaque psoriasis.- UCB.

 Added 23 days ago

The FDA has approved extending the label for Cimzia (certolizumab pegol), from UCB, to include a new indication in adults...

FDA approves Restylane Lyft as dermal filler for the back of the hands.- Galderma/Nestle.

 Added 1 month ago

The FDA has approved Restylane Lyft (hyaluronic acid), from Galderma/Nestle, dermal filler for the correction of age-related volume loss in...

FDA issues a Complete Response Letter to Evolus for DWP 450 a proposed treatment for glabellar lines.

 Added 1 month ago

Evolus, Inc.has announced updates related to the regulatory progress of its pending Biologics License Application (“BLA”) for DWP 450 (prabotulinumtoxinA)...

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