Articles

The FDA has approved cemiplimab-rwlc as the first immunotherapy for use in patients with advanced basal cell carcinoma that has previously been treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate.

FDA Approves Cemiplimab for Advanced Basal Cell Carcinoma

ZILXI (FMX103, VYNE Therapeutics), a 1.5% topical minocycline foam, is now available for prescription for the treatment of inflammatory lesions of rosacea in adult patients.

Topical minocycline for rosacea now available

UCB announces the U.S. Food and Drug Administration and the European Medicines Agency have accepted the Biologics License Application and Marketing Authorization Application for bimekizumab for the treatment of moderate-to-severe plaque psoriasis in adults.

FDA, EMA accepts marketing applications for bimekizumab in psoriasis

Merck announces positive results from its phase 2b trial evaluating sonelokinab, an investigational anti-IL-17 A/F nanobody, in adult patients with moderate-to-severe chronic plaque psoriasis. 

Sonelokinab demonstrates positive results in phase 2 psoriasis study

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for Sol-Gel’s Epsolay, a 5% microencapsulated benzoyl peroxide cream for the treatment of inflammatory lesions of rosacea or papulopustular rosacea. 

FDA accepts NDA filing for topical papulopustular rosacea treatment

Novartis announces their phase 3 study investigating spartalizumab (PDR001) in combination with dabrafenib (Tafinlar) and trametinib (Mekinist) failed to meet its primary endpoint. 

Spartalizumab phase 3 combination study fails to meet primary endpoint

MC2 Therapeutics and EPI Health announce they have entered into a collaboration agreement for the commercialization of calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064% (Wynzora Cream), a newly U.S. FDA-approved topical treatment for plaque psoriasis in adults.

MC2 Therapeutics collaborates EPI Health on newly approved psoriasis topical

Alembic Pharmaceuticals announces the launch of their bioequivalent and therapeutically equivalent product to Differin Gel 0.3% (Galderma), Adapalene Gel USP 0.3%, a topical retinoid for the treatment of acne vulgaris in patients 12 years and older. 

Alembic Pharmaceuticals launches adapalene gel for acne vulgaris 

Clascoterone cream 1% (Winlevi, Cassiopea), a first-in-class androgen receptor inhibitor, has been approved by the U.S. FDA for treatment of acne vulgaris in patients 12 years and older. 

Topical androgen receptor inhibitor approved by FDA for acne

Eli Lilly’s mirikizumab demonstrates superiority over secukinumab (Cosentyx, Novartis) as a treatment for moderate-to-severe plaque psoriasis, according to recently released results from the OASIS-2 study.

Drug Watch