FDA News and Regulatory Updates

Your daily dose of the clinical news you may have missed.

Dupilumab represents the first new treatment approach for uncontrolled COPD in more than a decade and reduced disease exacerbations by 34% in clinical trials.

Cobenfy, previously KarXT, is the first new agent with a novel mechanism of action for schizophrenia in more than 50 years, according to BMS.

Updated mRNA COVID-19 vaccines, the first orally disintegrating tablet approved for pregnancy prevention, and 5 more.

Your daily dose of the clinical news you may have missed.

FluMist is the first influenza vaccine that does not have to be given by a health care professional.

Boehringer Ingelheim announces plans to submit NDA for Investigational Therapy.

The updated COVID-19 vaccine targets the currently circulating Omicron variant JN.1 strain of SARS-CoV-2.

The Omnipod 5 is now the first automated insulin delivery system available for both T1D and T2D in the US.

The updated COVID-19 vaccines will include a monovalent component corresponding to KP.2, a strain of the Omicron variant of SARS-CoV-2.

Your daily dose of the clinical news you may have missed.

The First to Know Syphilis Test detects a current or past infection, regardless of successful treatment, in 15 minutes using a drop of blood.

The FDA recently accepted the sNDA for brexpiprazole in combination with sertraline and set a PDUFA target action date for February 2025.

Your daily dose of the clinical news you may have missed.

neffy (epinephrine nasal spray) is the first alternative to epinephrine administered by autoinjector or syringe and is comparable in efficacy to the gold standard.

Your daily dose of the clinical news you may have missed.

The Shield blood test is approved for primary CRC screening in adults 45 years and older at average risk for the disease.

The submission is based on data from OASIS trials that showed elinzanetant significantly reduced the frequency and severity of moderate-to-severe VMS associated with menopause.

Your daily dose of the clinical news you may have missed.

Lack of dosing experience and errors with converting measurement units may lead to overdosing, the agency reported.

The FDA requested an additional human factors study and more technical data on the final commercial product.

ICYMI: A quick look at 7 key drugs FDA-approved in the second quarter for conditions commonly seen in primary care.

Your daily dose of the clinical news you may have missed.

Your daily dose of the clinical news you may have missed.

The dual PDE3/PDE4 inhibitor is the first inhaled product with a novel mechanism of action approved for COPD in 2 decades and is delivered via standard jet nebulizer.