FDA News

Lykos Therapeutics' new drug application for MDMA plus psychiatric intervention for adults with PTSD will be the first reviewed by an FDA committee for such a therapy.

The April 2024 cardiology month in review spotlights FDA news and top updates from the American College of Cardiology 2024 Scientific Session.

FDA approves label update for voclosporin (Lupkynis) in lupus nephritis, reflecting long-term AURORA data and new kidney function monitoring guidance.

The current approval is based on the VOLTAIRE-HCLF clinical trial, which examined the bioavailability of high-concentration (100 mg/mL) and low-concentration (50 mg/mL) formulations of adalimumab-adbm.

The decision by Eli Lilly to resubmit lebrikizumab to the FDA for adults and adolescents with eczema is expected to receive a response in the second half of the year.

FDA issued a CRL the abbreviated new drug application of ketamine, which had sought to enhance accessibility to the limited drug supply.

Abbott's Esprit BTK System was shown to significantly reduce risk of ischemic events in patients with PAD versus angioplasty over 1 year.

FDA approves mavorixafor (XOLREMDI) for WHIM syndrome, the first approved treatment for the rare disease.

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.