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Pfizer Oncology announces a new FDA-approved indication for XALKORI® (crizotinib). 

Read the Full Prescribing Information

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FDA approves a new indication for LYNPARZA® (olaparib)

The US Food and Drug Administration (FDA) has approved a new indication for LYNPARZA® (olaparib) for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved […]

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Additional FDA approval for KEYTRUDA® announced

Merck announces that the FDA has approved KEYTRUDA® (pembrolizumab) Injection 100 mg for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.  •  PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients.  Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information. The Medication […]

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Merck announces new FDA approval for KEYTRUDA®

Merck would like to inform you that the FDA has approved KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.    •  PD-L1 diagnostic testing is required prior to initiating treatment with […]

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Takeda announces FDA approval for EXKIVITY™ (mobocertinib)

Takeda has announced that the US Food and Drug Administration (FDA) has approved EXKIVITY™ (mobocertinib), the first oral therapy to target epidermal growth factor receptor (EGFR) exon 20 insertion mutations in metastatic non-small cell lung cancer (NSCLC).1 EXKIVITY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic NSCLC […]

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Merck’s WELIREG™ (belzutifan) Receives FDA Approval

Merck has informed OSCO that WELIREG™ (belzutifan) 40-mg tablets has received FDA approval. WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. SELECTED SAFETY INFORMATION WARNING: EMBRYO-FETAL […]

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U.S. FDA Grants BRUKINSA® (Zanubrutinib) Approval in Waldenström’s Macroglobulinemia

BeiGene Ltd. Announces a new approval for BRUKINSA (zanubrutinib) in Waldenström’s macroglobulinaemia, including the updated Prescribing Information. For more information: Download BRUKINSA Full Prescribing Information Download BRUKINSA Patient Information BRUKINSA WEBSITE

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U.S. Food and Drug Administration Approves Opdivo® (nivolumab) for the Adjuvant Treatment of Patients with High-Risk Urothelial Carcinoma

On 8/20/21 Bristol Myers Squibb announced that Opdivo®(nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection, regardless of prior […]

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KEYTRUDA® receives additional FDA approval

The FDA has approved KEYTRUDA® (pembrolizumab) Injection 100 mg for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. Recommended Dosage for High-Risk Early-Stage TNBC Please refer to the Prescribing Information for KEYTRUDA for information […]

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FDA approves KEYTRUDA® (pembrolizumab) for additional treatment.

Merck has announced that the FDA has approved KEYTRUDA® (pembrolizumab) for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. PD-L1 diagnostic testing is […]

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