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MoonLake catapults on FDA deal for its down-and-out skin disease drug

Shares of MoonLake ImmunotherapeuticsMLTX catapulted Thursday after potentially aligning with the Food and Drug ...

MoonLake Says FDA May Allow Skin Drug Filing Without New Trials, Stock Soars

MoonLake says FDA may allow approval filing for its HS drug Sonelokimab without new trials after strong study results, keeping its 2026 submission plans on track.
Medical Device and Diagnostic Industry (MD+DI)

Skincubator Scores FDA Breakthrough Device Designation

The Skincubator is a wearable designed to enable immediate, prolonged skin-to-skin care for the tiniest preterm infants in ...

Alumis shares surge to record high as skin disease drug aces late-stage trials

Alumis said on Tuesday its experimental drug met the main goal of improving symptoms of a common skin disease in two late-stage studies, powering its shares to a record high and more than doubling ...

Alumis' skin disease drug meets main goal in late-stage trials; shares surge

Alumis said on Tuesday its experimental drug to treat a common skin disease met the main goal in two late-stage studies, offering hope for a new oral treatment option that affects millions of ...
UPI

FDA issues warning over skin peel treatments, orders retailers to halt sales

Aug. 2 (UPI) --The U.S. Food and Drug Administration is warning Americans of using certain chemical peel skin products because of a risk of serious skin injury, while issuing orders to major retailers ...
McKnight's Long-Term Care News

FDA approves drug to treat MRSA skin infections

The Food and Drug Administration has approved Dalvance (dalbavancin), an antibacterial drug used to treat adults with bacterial skin and skin structure infections. Among them are infections caused by ...
Healio

FDA clears AIV001 for testing for mixed BCC lesions in facial skin

Please provide your email address to receive an email when new articles are posted on . AIV001 is a pan-tyrosine kinase inhibitor for the nonsurgical treatment of mixed basal cell carcinomas. Injected ...
STAT

FDA clears AI skin cancer detector for primary care doctors to use

The Food and Drug Administration cleared an AI-powered device for detecting skin cancer on Wednesday, giving primary care physicians a new way to evaluate troubling skin spots. Around 5 million skin ...
The Hill

FDA convenes meeting on ‘mounting real-world evidence’ pulse oximeters are less accurate for people with darker skin

The Food and Drug Administration (FDA) held a meeting on Tuesday to examine and discuss what an agency panel called “mounting real-world evidence” suggesting that pulse oximeter devices do not provide ...
FiercePharma

Sol-Gel gets FDA approval for encapsulated skin disease drug

Sol-Gel Technologies’ work to expand the treatment options for patients with the skin condition rosacea has paid off, with the FDA approving a product based on its microencapsulation technology.
Medscape

FDA Warns Companies Selling OTC Skin Lighteners

The US Food and Drug Administration (FDA) issued warning letters to 12 companies selling over-the-counter (OTC) skin lightening products, the agency announced today. All the products contain ...