News from the FDA/CDC
News from the FDA/CDC
FDA approves Yuflyma as ninth adalimumab biosimilar
The manufacturer Celltrion is also seeking an interchangeability designation from the FDA, tentatively expected in the fourth quarter of 2024.
News from the FDA/CDC
FDA approves autoinjector pen for Humira biosimilar, Cyltezo
The drug will be commercially available on July 1, 2023.
News from the FDA/CDC
FDA OKs first-ever topical gene therapy, for rare skin disease
“Because it’s safe and easy to apply directly to wounds, it doesn’t require a lot of supporting technology or specialized expertise, making...
News from the FDA/CDC
CDC warns of Mpox resurgence in summer of 2023
Springtime and summertime gatherings and festivals could lead to renewed virus spread.
News from the FDA/CDC
FDA fast tracks potential CAR T-cell therapy for lupus
The cellular therapy depletes CD19-positive B cells with the goal of ‘‘resetting’’ the immune system to achieve durable remission.
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FMT in a pill: FDA approves second product to prevent C. diff recurrence
Clinicians now have two approved options for recurrent infections after antibiotic treatment.
News from the FDA/CDC
FDA approves injectable treatment for cheek lines, wrinkles
PLLA-SCA is indicated for use in people with healthy immune systems for correcting shallow-to-deep nasolabial fold contour deficiencies, fine...
News from the FDA/CDC
FDA approves new formulation of Hyrimoz adalimumab biosimilar
The agency approved a higher-concentration formulation of Hyrimoz for its previous indications, including rheumatoid arthritis and psoriasis.
News from the FDA/CDC
Cases of potentially deadly fungus jump 200%: CDC
People in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical...
News from the FDA/CDC
HIV testing still suboptimal
“If we just look at the need for HIV testing based on who is at risk, I think that we are always going to fall short.”
News from the FDA/CDC
FDA broadens warning on potentially contaminated eye products
An announcement released Wednesday adds to a...