Showing 1-10 of 106 results for "".
- Tirbanibulin Approved for Actinic Keratosishttps://practicaldermatology.com/news/tirbanibulin-approved-actinic-keratosis/2466999/The U.S. Food and Drug Administration (FDA) has approved tirbanibulin (Klisyri, Almirall) for the treatment of actinic keratosis on an expanded area of the scalp and face, according to a news release from the manufacturer. The tirbanibulin ointment, 1% is a microtubule inhibitor with a five-day ap…
- Biofrontera Launches Ameluz for Actinic Keratosishttps://practicaldermatology.com/news/biofrontera-launches-ameluz-for-actinic-keratosis/2458397/Biofrontera AG initiated the US commercial launch of its combination topical prescription drug Ameluz and medical device BF-RhodoLED, which has been FDA approved to treat mild to moderate actinic keratosis (AK) on the face and scalp. Ameluz is used in combination with the medical device BF-RhodoLE…
- Survey Shows Low Awareness, High Risk of Actinic Keratosis from Sun Exposurehttps://practicaldermatology.com/news/survey-shows-low-awareness-high-risk-actinic-keratosis-sun-exposure/2463197/A recent survey conducted by Almirall showed gaps in public awareness about actinic keratosis (AK) and the associated risks of sun exposure. The survey, which included more than 2,500 participants aged 35 and older from Spain, Germany, Italy, the United Kingdom, and the United States, revealed that…
- Vidac Queues Up Phase 2b Study for Potential Actinic Keratosis Therapyhttps://practicaldermatology.com/news/vidac-pharma-to-conduct-phase-2b-study-for-actinic-keratosis-therapeutic-candidate-vda-1102-with-centroderm/2462192/Vidac Pharma Holdings recently announced the commencement of a Phase 2b trial for its candidate therapy (VDA-1102) to treat actinic keratosis (AK), and has engaged with a research team from a leading clinical dermatology clinical research institute (CentroDerm GmbH). According to the manufacturer,…
- ACLARIS files NDA For Novel Seborrheic Keratosis Treatmenthttps://practicaldermatology.com/news/aclaris-files-nda-for-novel-seborrheic-keratosis-treatment/2458272/Aclaris Therapeutics, Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for A-101 40% topical solution (A-101) as a treatment for seborrheic keratosis (SK). If approved, A-101 would be the first FDA-approved topical treatment for SK. Aclaris also plans to s…
- FDA Accepts NDA for Almirall's AK Drug Tirbanibulinhttps://practicaldermatology.com/news/fda-accepts-nda-for-almiralls-ak-drug-tirbanibulin/2460299/The FDA has reviewed and accepted the New Drug Application (NDA) from Almirall, SA for tirbanibulin, also known as ALM14789, for the treatment of actinic keratosis (AK). The FDA also communicated that it is not currently planning on holding an advisory committee to discuss the application. The fi…
- Aclaris Submits Marketing Authorization Application in Europe for A-101 40% for Seborrheic Keratosishttps://practicaldermatology.com/news/aclaris-submits-marketing-authorization-application-in-europe-for-a-101-40-for-seborrheic-keratosis/2458100/Aclaris Therapeutics, Inc. has submitted a Marketing Authorization Application (MAA) with the Medicines Product Agency (MPA) in Sweden for its product candidate A-101 40% Topical Solution for the treatment of seborrheic keratosis. The MPA will act as the reference member state in this decentralized…
- Almirall: Phase 3 Studies of KX2-391 for AK Meet Primary Endpointshttps://practicaldermatology.com/news/almirall-phase-3-studies-of-kx2-391-for-ak-meet-primary-endpoints/2457676/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 achieved statistical significance on this endpoint. The double-blind, randomized, vehicle-controlled…
- Klisyri Launches for Treatment of AKshttps://practicaldermatology.com/news/klisyri-launches-for-treatment-of-aks/2460691/Klisyri® (tirbanibulin) ointment 1% is now available from Almirall, SA for the topical treatment of actinic keratosis (AK) of the face and scalp. Klisyri is supplied in boxes of 5 single-use sachets and is applied to the treatment area once daily for five days. "Klisyri will help address unmet nee…
- Almirall's Klisyri Gets FDA Approval for AKshttps://practicaldermatology.com/news/almiralls-klisyri-gets-fda-approval-for-aks/2460632/Almirall is expected to launch Klisyri® (tirbanibulin) for the topical treatment of actinic keratosis (AK) of the face or scalp in the first quarter of 2021, after receiving FDA approval this week. Klisyri® is a novel, topical first-in-class microtubule inhibitor with a short treatment protocol (…
- Prev
- Next