FDA Updates

Nymalize is an effective alternative to capsule extraction for adult patients with subarachnoid hemorrhage who are unable to swallow capsules.

Check out important updates from the FDA for the week of September 2.

DaylightRX from Big Health is a digital formulation of cognitive behavioral therapy and is available by prescription only.

Embecta’s new patch pump offers a larger insulin reservoir to better accommodate for the needs of patients with type 2 diabetes (T2D).

Bezisterim acts on inflammatory signaling pathways and may be a viable treatment option for post–COVID-19 condition, or long COVID.

The protein-based vaccine includes a monovalent component corresponding to the Omicron variant JN.1 strain.

Emergent BioSolutions has announced that it will donate 50,000 doses of ACAM2000 for potential deployment across affected areas in Central Africa.

Checkout these important FDA updates from the month of August 2024.

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

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.

Ascendis Pharma said it is currently completing manufacturing of commercial product, which it anticipates will be available in the US in the first quarter of 2025.

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.