Regulatory

The FDA’s clinical hold for the COVID and influenza vaccine trials was a result of a report of a serious adverse event involving motor neuropathy in a participant from a prior Phase II trial.

Submissions to the FDA and EMA for new indication of Darzalex Faspro are based on results of the Phase III Aquila trial in patients with high-risk smoldering multiple myeloma.

The Varipulse platform includes a single-device workflow with minimal to zero fluoroscopy requirements, real-time imaging, and lesion tagging for paroxysmal atrial fibrillation.

The subcutaneous form of Leqembi was previously granted Fast Track designation by the FDA to treat mild cognitive impairment or mild dementia associated with Alzheimer disease based on data from the Clarity AD study.

Accelerated approval is based on results of the ASC4FIRST Phase III trial, which demonstrated Scemblix's superior efficacy in achieving major molecular response compared to standard of care tyrosine kinase inhibitors in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Roxybond is the and only FDA-approved abuse-deterrent immediate-release 10 mg oxycodone formulation designed to reduce abuse of pain medication via intranasal and intravenous routes.

Despite a recent FDA Complete Response Letter issued to Lykos for midomafetamine capsules for the treatment of post-traumatic stress disorder, experts believe that the future is bright for psychedelic drugs that treat mental health conditions.

The expanded indication of Selarsdi for the treatment of diseases such as psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease is expected to support the official launch early next year.

Regulatory action marks the fourth aesthetic indication and the first beyond facial treatments for Botox.

Vyloy is the first CLDN18.2-targeted therapy for advanced gastric and gastroesophageal junction adenocarcinoma to be approved in the United States.

Priority Review status for GSK’s New Drug Application for gepotidacin was based on promising results from the Phase III EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin in uncomplicated urinary tract infections.

Expanded approval of Lumryz offers a once-nightly treatment option for younger patients, eliminating the need for traditional narcolepsy treatments that often require multiple doses throughout the night.

Vyalev is the first and only FDA-approved subcutaneous 24-hour infusion of a levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson disease.

Expanded indication of Bimzelx offers a prefilled syringe with a single 2 mL subcutaneous injection, improving upon the previous regimen of two 1 mL injections.

Hympavzi is the first anti-tissue factor pathway inhibitor therapy to be approved in the United States for routine prophylaxis of bleeding in patients with hemophilia A or B without inhibitors.

Approval was based on results from the Phase III INAVO120 trial, which found that Itovebi in combination with palbociclib and fulvestrant significantly improved progression-free survival in patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.

Healgen’s Rapid Check COVID-19/Flu A&B Antigen Test is the first non-prescription COVID-19/flu combination test to be authorized by the FDA without emergency use authorization.

Felzartamab granted Breakthrough Designation after a clinical trial showed a significant improvement in late antibody-mediated rejection in kidney transplant recipients compared with placebo.

Breakthrough Therapy designation for survodutide was based on preliminary clinical data showing potential improvement in patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis over existing therapies.

Approval was based on results from Phase I clinical safety studies, which demonstrated that using three tubes of Ameluz maintained similar safety and systemic exposure levels as one tube in treating actinic keratosis in patients undergoing photodynamic therapy.

Approval of Cologuard Plus follows results from the BLUE-C study, which demonstrated a 95% sensitivity for detecting colorectal cancer.

Approval for Opdivo was based on results from the CheckMate-77T trial, which demonstrated that the combination significantly improved event-free survival and pathologic complete response in adults with resectable non-small cell lung cancer without EGFR or ALK rearrangements.

Priority Review was based on data from the ECHO Phase III trial, which demonstrated that a combination of Calquence, bendamustine, and rituximab reduced the risk of disease progression or death by 27% in patients with previously untreated mantle cell lymphoma.

Marketed as a biosimilar to Stelara, approval of Otulfi was based on clinical data demonstrating comparable efficacy in treating inflammatory conditions such as Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis.

The application for Priority Review of Enhertu was supported by positive results from the DESTINY-Breast06 Phase III trial, which demonstrated that Enhertu reduced the risk of disease progression or death by 37% in patients with HER2-low or HER2-ultralow metastatic breast cancer.