Actinic Keratosis
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-06-03EMA Authorised: Ameluz (5-aminolevulinic acid hydrochloride) — Biofrontera Bioscience GmbH
EMA authorised Ameluz (5-aminolevulinic acid hydrochloride) for actinic keratosis and basal cell carcinoma.
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EMA approval · 2026-02-20EMA Authorised: Ameluz (5-aminolevulinic acid hydrochloride) — Biofrontera Bioscience GmbH
EMA authorized Ameluz (5-aminolevulinic acid hydrochloride) by Biofrontera Bioscience for actinic keratosis and basal cell carcinoma, markin…
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EMA approval · 2026-02-19EMA Authorised: Klisyri (tirbanibulin) — Almirall, S.A.
The European Medicines Agency authorised Klisyri (tirbanibulin) for actinic keratosis.
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EMA approval · 2025-07-22EMA Authorised: Zyclara (imiquimod) — Viatris Healthcare Limited
The EMA authorised Zyclara (imiquimod) for actinic keratosis, with Viatris Healthcare Limited listed as the marketing authorisation holder.
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EMA approval · 2025-07-18EMA Authorised: Aldara (imiquimod) — Viatris Healthcare Limited
The European Medicines Agency authorised Aldara (imiquimod) for multiple indications under Viatris Healthcare Limited, including genital war…
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FDA approval · 2024-10-04FDA Approved: AMELUZ — Supplemental Application (Biofrontera Inc.)
FDA approved a supplemental application for AMELUZ (aminolevulinic acid hydrochloride) from Biofrontera Inc. The action involves changes to …
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FDA approval · 2024-09-16FDA Approved: ZYCLARA — Supplemental Application (Bausch Health US, LLC)
FDA approved a supplemental application for ZYCLARA (imiquimod) filed by Bausch Health US, LLC.
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FDA approval · 2024-06-07FDA Approved: KLISYRI — Supplemental Application (Almirall, LLC)
The FDA approved a supplemental application for KLISYRI (tirbanibulin) by Almirall, LLC. This action pertains to the approved NDA 213189.
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FDA approval · 2022-05-26FDA Approved: FLUOROURACIL — Supplemental Application (Dr. Reddy's Laboratories Inc.)
The FDA approved a supplemental application for Fluorouracil Cream 0.5% by Dr. Reddy's Laboratories, expanding the marketed product to inclu…
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FDA approval · 2022-05-09FDA Approved: LEVULAN KERASTICK — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved a supplemental application for LEVULAN KERASTICK (amino levulinic acid hydrochloride) from Sun Pharmaceutical Industries, resul…
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FDA approval · 2021-05-25FDA Approved: AMELUZ — Supplemental Application (Biofrontera Inc.)
The FDA approved a supplemental application for AMELUZ (AMINOLEVULINIC ACID HYDROCHLORIDE) from Biofrontera Inc.
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FDA approval · 2021-01-26FDA Approved: IMIQUIMOD — Original Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical's Imiquimod as an Original Application (generic) product. It covers actinic keratosis, superficial basal…
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FDA approval · 2020-12-14FDA Approved: KLISYRI — Original Application (Almirall, LLC)
The FDA approved KLISYRI (tirbanibulin) 1% topical cream under its original application (NDA213189) from Almirall. It is indicated for actin…
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FDA approval · 2018-03-06FDA Approved: LEVULAN KERASTICK — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved a supplemental application for Levulan Kerastick (amino-levulinic acid hydrochloride) from Sun Pharmaceutical Industries, autho…
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FDA approval · 2017-09-06FDA Approved: AMELUZ — Supplemental Application (Biofrontera Inc.)
FDA approved a supplemental application for AMELUZ (AMINOLEVULINIC ACID HYDROCHLORIDE) by Biofrontera Inc., signaling a labeling expansion.
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FDA approval · 2016-08-29FDA Approved: IMIQUIMOD — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Imiquimod submitted by Sun Pharmaceutical Industries. This action typically updates labeling…
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FDA approval · 2016-05-10FDA Approved: AMELUZ — Original Application (Biofrontera Inc.)
The FDA approved AMELUZ (aminolevulinic acid hydrochloride) from Biofrontera for the topical treatment of actinic keratosis of the face and …
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FDA approval · 2016-01-07FDA Approved: LEVULAN KERASTICK — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved a supplemental application for LEVULAN KERASTICK (aminolevulinic acid hydrochloride) from Sun Pharmaceutical Industries, expand…
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FDA approval · 2014-11-20FDA Approved: FLUOROURACIL — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for Fluorouracil Cream, 0.5% from Dr. Reddy's Laboratories Inc. This action updates the product's la…
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FDA approval · 2013-11-14FDA Approved: LEVULAN KERASTICK — Supplemental Application (Sun Pharmaceutical Industries, Inc)
The FDA approved a supplemental application for Levulan Kerastick (aminolevulinic acid hydrochloride) from Sun Pharmaceutical Industries, In…
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FDA approval · 2012-03-06FDA Approved: IMIQUIMOD — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's generic imiquimod 5% cream (ANDA 201994) as an original application, expanding access to the dermatology indications…
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FDA approval · 2011-04-15FDA Approved: IMIQUIMOD — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical Industries' imiquimod generic under an Original Application (ANDA 200173) for the same indications as the br…
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FDA approval · 2011-03-24FDA Approved: ZYCLARA — Supplemental Application (Bausch Health US, LLC)
The FDA approved a supplemental application for ZYCLARA (imiquimod) from Bausch Health US, LLC.
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FDA approval · 2010-09-07FDA Approved: IMIQUIMOD — Original Application (Padagis Israel Pharmaceuticals Ltd)
The FDA approved Padagis Israel Pharmaceuticals Ltd's imiquimod generic (ANDA 078837) for actinic keratosis, superficial basal cell carcinom…
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FDA approval · 2010-03-25FDA Approved: ZYCLARA — Original Application (Bausch Health US, LLC)
The FDA approved ZYCLARA (imiquimod) 3.75% cream from Bausch Health US, LLC as an Original Application (NDA022483). The product is approved …