FDA Updates

The device was previously cleared for use in children and adults with type 1 diabetes.

Check out important updates from the FDA for the week of August 19.

Novavax is still awaiting FDA authorization for their protein-based COVID-19 vaccine.

FDA approval of Amneal Pharmaceuticals' propofol injectable emulsion single-dose vials aims to address the drug’s history of chronic supply issues.

Final approval of the therapy may occur after expiration of the 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025.

First To Know Syphilis Tests are expected to be available at major national retailers and online in late 2024.

Check out important updates from the FDA for the week of August 12.

Medtronic also announced it has entered a global partnership with Abbott in an effort to expand CGM device options for patients living with diabetes.

Two phase 3 trials evaluating nemolizumab found that 41% of patients treated with the therapy achieved at least a 4-point reduction in itch intensity at week 16.

The agency said it could not approve the new drug application based on the submitted data and requested an additional Phase 3 trial to “further study the safety and efficacy” of the therapy.

The epinephrine nasal spray from ARS Pharmaceuticals has become the first and only needle-free epinephrine alternative and the first new delivery method for epinephrine in over 3 decades.

Check out important updates from the FDA for the week of August 5.

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses the implications of a potential FDA approval of MDMA-assisted therapy for PTSD.

In a clinical trial, IPX203 was able to achieve longer good on-time with less doses compared to standard treatment.

Nalmefene injection is an opioid receptor antagonist and comes in a single-dose, pre-filled auto-injector that delivers 1.5 mg of the medication per actuation.

Check out important updated from the FDA for the week of July 29.

Afami-cel is the first new treatment for synovial sarcoma in more than 10 years, ending a long-standing therapeutic gap.

Pharmacists should be knowledgeable about the symptoms of chemical peel irritation to effectively advise patients.

In 3 Phase 3 trials, elinzanetant reduced the frequency and severity of moderate to severe vasomotor symptoms, and improved sleep disturbances.

The investigational oral, selective NaV1.8 pain signal inhibitor from Vertex Pharmaceuticals demonstrated a favorable benefit/risk profile in 3 phase 3 trials.

The new FDA-approved presentation will be the company’s third 505(b)(2) injectable added in 2024, expected to launch in the third quarter.

Check out these important FDA updates from the month of July 2024.

Check out important updates from the FDA from over the past week.

The approval of eculizumab-aagh offers more treatment options for patients with rare diseases PNH and aHUS.

The approval offers a first of its kind treatment option for patients living with nonerosive GERD.

The companies are marketing products that may violate Federal Trade Commission prohibition of “unfair and deceptive acts in the marketplace.”

Had Novo Nordisk’s insulin icodec secured FDA approval, it would have been the first and only once-weekly basal insulin option for adults with diabetes.

The commercial product is expected to be available by the end of July.