The FDA has approved roflumilast (ZORYVE) foam 0.3% for once-daily treatment of plaque psoriasis in patients aged 12 and older, including hard-to-treat scalp and body areas..
The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."
A hospital-derived strain of Pseudomonas aeruginosa was found to degrade medical plastic, use it as food, and form stronger biofilms, revealing new risks for device-related infections.
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Selarsdi (ustekinumab-aekn) was approved by the FDA as an interchangeable biosimilar to Stelara (ustekinumab) for all approved indications, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
The FDA approved Rinvoq (upadacitinib) as the first and only oral Janus kinase inhibitor for the treatment of giant cell arteritis in adults, providing a steroid-sparing option for achieving sustained remission.
The FDA has issued a safety alert on compounded topical finasteride products, citing adverse events and emphasizing the lack of regulatory approval or safety evaluation.