FDA News

The announcement by Dermavant followed positive findings from the ADORING trials on tapinarof and an open label extension for children aged 2 - 17.

FDA approves the generic equivalent of Narcan HCI Nasal Spray—naloxone hydrochloride (Naloxone HCI)—for an emergency treatment option for an opioid overdose.

Abeona's pz-cel is up for indicated use to treat patients with recessive dystrophic epidermolysis bullosa.

Announced on April 18, the approval is based on the VISIBLE 2 trial and comes less than 7 months after the approval of SC vedolizumab in ulcerative colitis.

Fresenius announced the immediate availability of its tocilizumab biosimilar, tocilizumab-aazg (Tyenne), in the US.

The FDA approval of benralizumab for patients ages 6 to 11 with asthma follows the conclusions of the phase 3 TATE study.

Madrigal Pharmaceuticals announced resmetirom is available in the US beginning on April 9, 2024, ushering in a new era of NASH management.

The FDA announcement on bimekizumab’s supplemental Biologics License Application followed the phase 3 BE HEARD I and II studies’ conclusion.

Less than 2 months after being the subject of an FDA AdComm meeting, Abbott's TriClip TEER System has received approval for tricuspid regurgitation.

The FDA approved iloperidone for acute treatment of bipolar I disorder on April 02, 2024, according to Vanda Pharmaceuticals.

A recap of the biggest FDA news and decisions in cardiovascular medicine from the first 3 months of 2024, with commentary on recent announcements by Deepak Bhatt, MD, MPH, MBA.

Verve Therapeutics announced plans to voluntary pause enrollment of the Heart-1 trial, citing an adverse event and consultation with DSMB, with plans to shift focus to VERVE-102 and Heart-2 trial.

FDA issued a warning for the the Impella left-sided blood pumps as it had received many reports of heart-wall tears, increasing the risk of death, hypertension, and more.

Vadadustat tablets are now approved for the treatment of anemia due to CKD in adults who have been receiving dialysis for ≥ 3 months.

The FDA identified high concentration of lidocaine across marketed, over-the-counter topical products from 6 different companies.

Michael Weber, MD, lead of the PRECISION trial, discusses the significance of the aprocitentan (Tryvio) approval and key points for providers who may have patients with uncontrolled hypertension.

The approval marks the first and only once-daily single-tablet combination therapy for patients with pulmonary arterial hypertension.

The FDA's approval of the label expansion for bempedoic acid to include cardiovascular risk reduction is based on data from the CLEAR Outcomes trial.

Idorsia Ltd. announced the FDA's approval of aprocitentan (Tryvio) for treatment-resistant hypertension on March 20, 2024.

The FDA has cleared Sequel's twiist, a novel automated insulin delivery system, expanding patient choice for individuals with type 1 diabetes.

Approvals by both the FDA and the Chinese NMPA have followed recent clinical trial data on spesolimab injection in GPP patients.

On March 15, 2024, the FDA approval of fluticasone propionate nasal spray marks the first approval in agency history for treatment of chronic rhinosinusitis without nasal polyps.

In a landmark decision, the FDA has granted accelerated approval to resmetirom (Rezdiffra) for noncirrhotic NASH with moderate to advanced fibrosis.

Saeed Mohammed, MD, MS, discusses maralixibat for pruritus in PFIC, describing how IBAT inhibitors have changed the way clinicians are able to treat cholestatic liver disease.

The submission could grant guselkumab its third indication, after being approved by the FDA for psoriasis and psoriatic arthritis.

Nearly a decade after becoming the first PCSK9 inhibitor to receive approval from the FDA, alirocumab (Praluent) has now received approval for pediatric patients with HeFH based on data from a phase 3 trial.

On March 08, 2024, the FDA approved semaglutide 2.4 mg (Wegovy) to reduce cardiovascular risk in adults with obesity or overweight and heart disease based on the SELECT trial.

FDA issued a Complete Response Letter to Vanda Pharmaceuticals stating tasimelteon for treating insomnia cannot be approved in its current form due to identified deficiencies.

The FDA has greenlit Dexcom's Stelo Glucose Biosensor System, marking a historic first as the first continuous glucose monitors to be available over-the-counter.

The decision was based on clinical studies demonstrating no clinically meaningful differences between the biosimilar and its reference product.