561 Results

FDA approves Afinitor Disperz for tuberous sclerosis complex.- Novartis.

 Added 13 days ago

The FDA has approved Afinitor Disperz (everolimus tablets for oral suspension), manufactured by Novartis Pharmaceuticals, to treat partial-onset seizures in...

Journal of the American Academy of Dermatology (JAAD) has published positive two Phase III, multicenter, randomized, double-blind clinical trials (Studies 1 and 2) for psoriasis, to assess the safety and efficacy of DUOBRII.- Ortho Dermatologics.

 Added 15 days ago

Ortho Dermatologics, a division of Valeant Pharmaceuticals North America, LLC announced that the Journal of the American Academy of Dermatology...

NICE rejects Dupixent for atopic dermatitis in a preliminary decision. - Sanofi.

 Added 20 days ago

The National Institute for Health and Care Excellence (NICE) has issued draft guidance that does not recommend Dupixent (dupilumab), within...

EMA accepts for review cemiplimab MAA for the treatment of patients with metastatic cutaneous squamous cell carcinoma. Sanofi + REgeneron

 Added 21 days ago

The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for cemiplimab for the treatment of...

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

 Added 21 days ago

Motif Bio plc announced the initiation of a rolling submission of a New Drug Application (NDA) to the FDA for...

FDA approves Ilumya for moderate-to-severe plaque psoriasis.- Sun Pharma.

 Added 1 month ago

The FDA has approved Ilumya (tildrakizumab-asmn), from Sun Pharma, for the treatment of adults with moderate-to-severe plaque psoriasis who are...

FDA accepts sBLA for Rituxan (rituximab) as a treatment for pemphigus vulgaris.- Genentech/Roche

 Added 1 month ago

Genentech, a member of the Roche Group announced that the FDA has accepted the company’s Supplemental Biologics License Application (sBLA)...

NDA application to FDA of iclaprim to treat acute bacterial skin and skin structure infections is delayed to second quarter of 2018.-Motif Bio plc.

 Added 1 month ago

Motif Bio plc a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, provided an update on the status and timeline...

DRM 01 fails two Phase III trials for treatment of acne.- Dermira Inc.

 Added 1 month ago

Dermira Inc. announced that DRM 01 ( olumacostat glasaretil) failed to meet its co-primary endpoints in two Phase III trials,...

Quofenix filed in EU for infectious diseases (ABSSSI).- Melinta Therapeutics.

 Added 1 month ago

Melinta Therapeutics announced that The Menarini Group, Melinta’s commercial and co-development partner, has submitted a Marketing Authorization Application (MAA) to...

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