FDA News

This marketing authorization by the FDA allows the Hearing Aid Feature to be implemented alongside compatible Apple AirPod Pro headphones.

The agency's designation was granted to plozasiran as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.

The decision is based on rates of clinical and endoscopic remission with guselkumab in the ongoing phase 2b/3 QUASAR study.

In this episode, hosts discuss availability of the Abbott Lingo CGM and Embecta’s announcement of FDA clearance for their tubeless patch pump with a 300-unit insulin reservoir.

The FDA has granted full approval to sparsentan (Filspari) for slowing kidney function decline in adults with IgAN at risk of disease progression based on PROTECT trial data.

FDA expands Omnipod 5 AID system for type 2 diabetes, marking the first AID system approved for both type 1 and type 2 diabetes management.

Dexcom's Stelo, the first OTC glucose sensor, launches in the US on August 26, 2024, offering 15-day wear and HSA/FSA eligibility for as low as $89.99 per 2-pack.

The accelerated approval is based on phase 3 data demonstrating seladelpar’s impact on ALP reduction and is contingent upon verification and description of clinical benefit in confirmatory trial(s).

The drug is the first approved monoclonal antibody specifically designed to inhibit the IL-31 pathway, a driver of prurigo nodularis.

Palopegteriparatide’s approval was based on positive data from the global Phase 2 PaTH Forward and Phase 3 PaTHway trials.

The US FDA has issued a CRL and requested an additional phase 3 trial for MDMA-assisted therapy in the management of PTSD.

The FDA approved epinephrine nasal spray (Neffy) for the emergency treatment of allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh at least 30 kg.

On August 07, 2024, Novartis announced the FDA's accelerated approval of iptacopan for reducing proteinuria in primary IgAN based on interim data from APPLAUSE-IgAN.

FDA approval for the Simplera™ continuous glucose monitor marks the company's first disposable, all-in-one CGM half the size of previous offerings.

On August 6, 2024, the FDA warned against using unapproved inhalant products marketed for alertness and energy, citing reports of adverse events including seizures and fainting.

This extended-release injectable suspension for schizophrenia and schizoaffective disorder is approved as a monotherapy and as an adjunct to mood stabilizers or antidepressants.

This designation was based on the ORCA-V1 trial’s phase 2 findings indicating that cytisinicline more than doubled patients’ odds of e-cigarette cessation versus placebo.

The approval of Guardant Health’s Shield test makes it the first blood test to be approved as a primary screening option for CRC and the first to meet Medicare coverage requirements.

Brett King, MD, PhD, discusses how the deuruxolitinib approval impacts the treatment landscape of alopecia areata.

In this part of our 5-part series, Gus Alva, MD discusses the unmet need in PTSD treatment and the potential of MDMA-assisted therapy.

Adults with severe alopecia were shown to have statistically significant efficacy across 2 phase 3 clinical studies highlighted in this announcement.

The expanded label includes use in patients with PFIC 12 months of age and older as well as a higher concentration formulation.

Johnson & Johnson submits a supplemental New Drug Application to the FDA for the approval of esketamine as a monotherapy for adults with treatment-resistant depression.

The approval was based on the clinical, non-clinical, and analytical data proving eculizumab-aagh's bioequivalence to the reference drug.

Announced on July 18, 2024, the FDA approval for heartburn relief associated with non-erosive GERD is based on the phase 3 PHALCON-NERD-301 trial.