FDA

FDA concluded that AXS-14’s New Drug Application was not sufficiently complete for substantive review, citing concerns with one of two clinical trials in fibromyalgia patients.

Approval was based on results from the Phase III ARANOTE trial, in which Nubeqa demonstrated a 46% reduction in the risk of radiographic progression or death when combined with androgen deprivation therapy, in patients with metastatic castration-sensitive prostate cancer.

New drug application submission was based on positive data from the Phase III GLISTEN trial, which demonstrated significant and sustained reductions in pruritus and related sleep disruption in patients treated with linerixibat.

Approval was based on data from the Phase III NextCOVE trial, which demonstrated that mNEXSPIKE met non-inferiority criteria compared to the original Spikevax as a vaccine for COVID-19.

Approval of Nucala marks the first biologic approved for chronic obstructive pulmonary disease patients with blood eosinophil counts as low as ≥150 cells/μL.

Approval of Susvimo marks the first continuous delivery therapy indicated for diabetic retinopathy.

Clearance of ASC50 paves the way for a Phase I trial in patients with mild-to-moderate plaque psoriasis.

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.

Positive feedback was based on Phase III AQUILA trial results, which showed a significant clinical benefit with Darzalex Faspro in patients with high-risk smoldering multiple myeloma.

Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.

Zynyz is the first and only FDA-approved first-line treatment for adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal.

Welireg marks the first FDA-approved non-surgical treatment option for locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma in patients over 12 years of age.

Emrelis is the first FDA-approved treatment for previously treated patients with locally advanced or metastatic non-squamous non-small cell lung cancer with high c-Met protein overexpression.

The decision follows ongoing investigations into serious adverse events primarily reported in elderly individuals who received the Ixchiq chikungunya vaccine.

The Avmapki Fakzynja Co-Pack marks the first FDA-approved treatment for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.

The Refusal to File letter comes despite the FDA’s prior encouragement to submit a supplemental biologics license application for Anktiva in patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary disease.

Selarsdi, a biosimilar to Stelara, is approved for adult and pediatric psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis.

AbbVie secures FDA approval for Rinvoq as the first oral Janus kinase inhibitor indicated for giant cell arteritis, expanding its immunology portfolio and signaling strategic growth opportunities in underserved autoimmune markets.

IQVIA’s Doug Long offers a lay of the land, including trends and developing issues that are shaping the current market.

Approval of penpulimab-kcqx marks the company’s US regulatory debut and introduces a new immunotherapy option for advanced nasopharyngeal carcinoma.

The submission is backed by clinical data from over 2,100 patients, including two pivotal Phase III trials in patients treated with trenibotulinumtoxinE for moderate to severe glabellar lines.

The simplified requirements for Camzyos are expected to ease prior contraindications, thereby simplifying treatment and expanding eligibility in patients with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy.

Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and adolescents over 12 years of age in over a decade.

Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks achieved non-inferior visual acuity outcomes compared to Eylea in patients with macular edema following retinal vein occlusion.

Approval of Opdivo plus Yervoy combination was based on results from the Phase III CheckMate-9DW trial, which demonstrated significantly improved overall survival and overall response rate in patients with unresectable or metastatic hepatocellular carcinoma.