FDA News and Regulatory Updates

The Agency's priority review of the prescription-OTC switch underscores the urgent need for broader access to the opioid overdose reversal agent.

The single-dose biotherapeutic remained effective through 6 months for more than 90% of phased 3 clinical trial participants, according to Ferring Pharmaceuticals.

Your daily dose of clinical news you may have missed.

Your daily dose of clinical news you may have missed.

Teplizumab, an anti-CD3 monoclonal antibody, delayed the median onset of stage 3 T1D by approximately 2 years compared to placebo in a pivotal clinical trial.

A preliminary assessment from the FDA suggests certain naloxone products may be safely used without a prescription to prevent opioid overdose deaths.

The FDA accepted the GSK BLA and granted priority review to what could be the first vaccine approved against RSV in adults aged ≥60 years, according to the company.

Another choice of booster may help increase follow-up vaccination among the 50% of US adults who have yet to get a first booster dose.

The FDA amended EUAs for omicron-adapted vaccines from both Pfizer and Moderna, authorizing the shots for children and adolescents.

Novel NMDA receptor antagonist approved for the treatment of major depressive disorder, first topical PDE4i approved for plaque psoriasis, and more.

The first-in-class dual incretin receptor agonist was granted fast track designation for investigation in adults with obesity or overweight with weight-related comorbidities.

Only 1 lot of each medication was affected by the mislabeling, according to generic repackaging and distribution services company Golden State Medical Supply.

Data from the pivotal phase 3 FIGARO-DKD cardiovascular outcomes trial with finerenone reaffirms the agent's dual cardiorenal risk reduction benefits in T2D-associated CKD.

Abelacimab is a dual-acting, fully human monoclonal antibody that selectively targets both factor XI and factor XIa with high affinity.

The FDA EUA amendments for updated booster vaccinations are based on clinical studies of the omicron BA.1 variant and preclinical data on the BA.4 and BA.5 variants.

The dextromethorphan HBr-bupropion HCI combination uses the first new oral MOA in 6 decades and is labeled to improve depressive symptoms starting at 1 week.

Moderna filed with the FDA for emergency use authorization of a 50-µg dose of a BA.4./BA.5 Omicron-targeting bivalent booster vaccine for those aged ≥18 years.

Pfizer-BioNTech filed with the FDA for emergency use authorization of a 30-mcg dose of an Omicron BA.4.BA.5-adapted vaccine for those aged ≥12 years.

The FDA now recommends serial testing following a negative result on any at-home COVID-19 antigen test to reduce the risk of a false negative result.

A smaller dose given by intradermal injection will expand the total US supply by a factor of 5, FDA says.

Medicare Advantage plans may cut treatment corners to avoid more costly but more effective and targeted therapy for diabetes patients.

The FDA's move could potentially improve Paxlovid access for patients at high risk for severe COVID-19 who have limited access to health care.

The FDA recommended on Thursday the inclusion of a SARS-CoV-2 Omicron component in COVID-19 vaccine booster doses.

If the atogepant label is expanded, the drug will be the only gepant approved for the broad indication of prevention of both episodic and chronic migraine.

The new approval for risankizumab makes it the only interleukin-23 inhibitor for moderately to severely active Crohn disease, according to AbbVie.