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Polivy (polatuzumab vedotin-piiq)

Chemoimmunotherapy Regimen Approved to Treat DLBCL

Polivy approved in combination with bendamustine, rituximab for diffuse large B-cell lymphoma
The U.S. Food and Drug Administration granted Emgality (galcanezumab-gnlm) solution the first approval for treating episodic cluster headache

Emgality Receives First FDA Approval for Treating Cluster Headache

Patients treated with Emgality had 8.7 fewer cluster headache attacks at 3.0 weeks versus 5.2 with placebo
Zerbaxa (ceftolozane and tazobactam) has been approved for a new indication to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients aged 18 years and older

Zerbaxa Approved for Hospital-Acquired Bacterial Pneumonia

Drug previously approved for treatment of complicated intra-abdominal infections, UTIs
Piqray (alpelisib) tablets were approved for the treatment of hormone receptor-positive

First PI3K Inhibitor Approved for Metastatic, Advanced Breast Cancer

Piqray approved for HR-positive, HER2-negative, PIK3CA-mutated, metastatic or advanced breast cancer
The first gene therapy has been approved to treat children younger than 2 years with spinal muscular atrophy

FDA Approves First Gene Therapy for Spinal Muscular Atrophy

Patients treated with Zolgensma have shown improvement in reaching developmental motor milestones
Fragmin (dalteparin sodium) injection has been granted the first approval for subcutaneous use in preventing recurrence of symptomatic venous thromboembolism in children aged 1 month or older

First Anticoagulant Approved for Preventing VTE Recurrence in Children

Boxed warning lists risk for epidural, spinal hematomas with neuraxial anesthesia, spinal puncture
Venetoclax (VENCLEXTA) has been approved to treat adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma

FDA Approves Venetoclax for Chronic Lymphocytic Leukemia

In randomized trial, drug demonstrated statistically significant improvement in progression-free survival
Avelumab (BAVENCIO) was approved this week for first-line treatment of advanced renal cell carcinoma in combination with axitinib

Avelumab + Axitinib Approved for Treatment of Renal Cell Carcinoma

Treatment combination demonstrated longer progression-free survival versus sunitinib in randomized trial
Venetoclax (VENCLEXTA) has been approved to treat adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma

FDA Approves Venetoclax for Chronic, Small Lymphocytic Leukemia

In randomized trial, drug demonstrated statistically significant improvement in progression-free survival
Ruzurgi (amifampridine) tablets are now approved to treat Lambert-Eaton myasthenic syndrome in children aged 6 to 17 years

FDA Approves Ruzurgi for Children With Rare Autoimmune Disorder

Ruzurgi previously approved for treatment in adults with Lambert-Eaton myasthenic syndrome