FDA

BIIB080 marks the first antisense oligonucleotide targeting tau to enter clinical development for the treatment of Alzheimer disease.

Qfitlia is the first FDA-approved antithrombin-lowering therapy indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients over 12 years of age with hemophilia A or B.

Approval of Imfinzi marks the first and only perioperative immunotherapy indicated for muscle-invasive bladder cancer.

As part of the Fast Track designation, Sanofi is set to launch a Phase I/II trial to evaluate the immunogenicity and safety of its novel mRNA vaccine in preventing chlamydia.

Approval of Vykat XR marks the first treatment indicated for hyperphagia in patients with Prader-Willi syndrome.

Blujepa marks the first new oral antibiotic to gain FDA approval for uncomplicated urinary tract infections in nearly 30 years.

Fanhalta marks the first and only treatment for C3 glomerulopathy to gain FDA approval.

What biopharma companies need to know about this evolving regulatory pathway.

Omlyclo, a biosimilar to Xolair, is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergies, and chronic spontaneous urticaria.

The approval of neffy marks the first major advancement in epinephrine delivery for patients over four years of age in more than 35 years.

Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients with lupus nephritis who received Gazyva/Gazyvaro plus standard therapy achieved a complete renal response.

New indication for Tevimbra in combination with platinum-containing chemotherapy as a first-line treatment addresses an unmet need for adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.

Stoboclo, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Osenvelt, a biosimilar to Xgeva, is indicated for preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors.

In the SWIFT and ANCHOR trials, depemokimab demonstrated statistically significant reductions in nasal polyp size, obstruction, and asthma exacerbations compared to placebo.

Results from a Phase III study in pediatric patients demonstrated that Odactra reduced the total combined rhinitis score by 22% compared to placebo.

The YouScript CEO discusses new FDA guidance.

The application leverages existing clinical data for Uzedy along with prior FDA findings on the safety of Udezy in patients with bipolar I disorder.

Surgifort is the first FDA-approved human milk-based fortifier specifically designed for term infants recovering from gastroschisis surgery.

Keytruda demonstrated a statistically significant and clinically meaningful improvement in event-free survival and major pathological response in patients with resectable locally advanced head and neck squamous cell carcinoma.

Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be approved by the FDA for complicated intra-abdominal infections with limited treatment options.