FDA News

Announced on September 18, 2024, the approval of benralizumab for adults with EGPA, which is based on the MANDARA trial, marks the second FDA approval for EGPA.

The FDA has approved the Eversense 365, the world’s first 1-year continuous glucose monitor, with US availability expected in late 2024.

The FDA advises stopping the fezolinetant treatment at the first signs of liver injury to prevent further damage and help restore normal liver function.

Nanoscope Therapeutics announced the meeting with the FDA supported the advancement of MCO-010 into Phase 3 for Stargardt disease.

Eli Lilly’s announcement of the lebrikizumab-lbkz approval for patients 12 years of age and older follows positive findings from the ADvocate 1, ADvocate 2, and ADhere studies.

This approval expands the drug’s age range and follows recent positive phase 3 findings on dupilumab treatment for patients aged 12 to 17 with CRSwNP.

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.

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.

The repository corticotropin injection is designed to help patients manage their medication alongside a range of chronic and acute autoimmune and inflammatory conditions.

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.

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.

The CRL cites requests related to the manufacturing process and the type 1 diabetes indication before the application review can be completed.