FDA News

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.

This decision by FDA officials resulted from the INTEGUMENT study findings which determined that once-daily roflumilast led to rapid eczema clearance and significant disease reductions.

After a busy first half to 2024, a number of high-impact FDA decisions await the healthcare industry through December.

Announced by Genentech on July 04, 2024, the prefilled, 6.0 mg syringe is designed to improve ease of administration and offer ophthalmologists with a ready-to-use version of the bispecific antibody.

Our Cardiology Month in Review for June 2024 spotlights the pharmacotherapies making waves within the pipeline, the latest news in dyslipidemia, and updates in heart failure.

Neurocrine Biosciences was granted Priority Review designations for two crinecerfont NDAs focused on children, adolescents, and adults with classic CAH.

A review of the 20 novel drugs approved by the US Food and Drug Administration during the first half of 2024, with links to coverage from MJH Life Sciences publications.

Mirum Pharmaceuticals submitted an NDA for chenodiol tablets to treat CTX based on positive phase 3 RESTORE trial results.

The marketing authorization makes the Xpert HCV test and GeneXpert Xpress System the first point-of-care test for diagnosing HCV.