The FDA has approved Eli Lilly’s Zepbound for treating obstructive sleep apnea, marking the first drug specifically for this common sleep disorder. Zepbound, containing tirzepatide, a GLP-1 agonist, showed significant effectiveness in clinical trials and could significantly impact the market, given the billions affected by sleep apnea. This approval positions Lilly competitively against other pharmaceutical companies developing similar treatments.
The FDA fully approved Humacyte’s HUMA Symvess, a bioengineered vascular conduit, for treating extremity arterial injuries. Symvess provides a faster, off-the-shelf alternative to traditional vein grafts, reducing surgery time and patient trauma. The approval is supported by clinical trial data and real-world evidence from Ukraine. This breakthrough offers a significant advancement in treating life-threatening vascular injuries.
The FDA has approved Mesoblast’s Ryoncil, the first mesenchymal stromal cell therapy in the US, for treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children. This innovative treatment demonstrated a 70% overall response rate in a Phase 3 trial. The approval marks a significant advancement in pediatric oncology and has positively impacted Mesoblast’s stock price.
Checkpoint Therapeutics’ Unloxcyt (cosibelimab-ipdl) received FDA approval for treating metastatic cutaneous squamous cell carcinoma (cSCC). This is the first PD-L1 blocking antibody approved for this indication. Unloxcyt is administered intravenously at 1200 mg every three weeks. The approval comes after a previous setback related to manufacturing, not the drug’s efficacy or safety. CKPT stock saw a premarket surge following the news.
UniQure’s AMT-130, a potential breakthrough treatment for Huntington’s disease, has been granted an accelerated approval pathway by the FDA. This decision, based on promising Phase I/II clinical trial data, sends QURE stock soaring in premarket trading.
BridgeBio Pharma’s Attruby (acoramidis) receives FDA approval for treating ATTR-CM, marking a significant advancement in addressing this rare cardiovascular disease. The drug’s unique mechanism and positive Phase 3 trial results offer hope for patients, while its market positioning relative to Pfizer’s tafamidis sparks industry discussion.
The U.S. Food and Drug Administration (FDA) has approved a groundbreaking device called the Valeda Light Delivery System for the treatment of dry age-related macular degeneration (AMD), a leading cause of vision loss. The device utilizes light-emitting diodes (LEDs) to potentially improve mitochondrial function and blood flow in the retina, offering hope for millions affected by this debilitating condition.
Novo Nordisk’s Wegovy (semaglutide 2.4 mg) has shown positive results in treating metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis in a Phase 3 trial. The drug demonstrated significant improvement in liver fibrosis compared to placebo, potentially paving the way for regulatory approval in the US and EU in the first half of 2025.
Iterum Therapeutics has secured FDA approval for its Orlynvah (sulopenem etzadroxil and probenecid) to treat uncomplicated urinary tract infections (uUTIs) in adult women. This is the first FDA-approved product for Iterum and offers a new treatment option for women with limited alternative oral antibacterial treatment options. The approval was based on two successful Phase 3 clinical trials demonstrating Orlynvah’s safety and efficacy compared to existing treatments.
The FDA has expanded the use of Pfizer’s Abrysvo RSV vaccine, now offering protection to adults aged 18-59 at high risk for respiratory illness. This move broadens the vaccine’s reach, providing a vital safeguard against RSV for a larger population, including pregnant women who can protect their infants. The decision is based on the success of the MONeT study, highlighting the vaccine’s safety and effectiveness. The approval comes as RSV vaccine sales have declined following regulatory adjustments, underscoring the crucial role Abrysvo plays in building new revenue streams for Pfizer.
