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FDA Approves KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 with Disease Progression On or After Platinum-Containing Chemotherapy

IndicationPharmacodia.com2015-10-04 00:00 Read   1214

The U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab) monotherapy, the company’s anti-PD-1 (programmed death receptor-1) therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Santhera Receives European Marketing Authorization for Raxone in Leber’s Hereditary Optic Neuropathy (LHON)

IndicationPharmacodia.com2015-09-09 00:00 Read   601

First Approved Treatment for LHON and First Approved Treatment for a Mitochondrial Disease.

US FDA approves expanded indication for Brilinta to include long-term use in patients with a history of heart arrack

IndicationPharmacodia.com2015-09-03 00:00 Read   704

US FDA has handed down an approval for AstraZeneca’s blood thinner Brilinta expanding indication of long-term use of the drug in patients who have previously suffered heart attacks, in Sep 3, 2015.

U.S. FDA approved Pfizer‘s Sirolimus for the treatment of lymphatic smooth muscle hyperplasia (LAM)

IndicationPharmacodia.com2015-05-28 00:00 Read   373

On May 28,2015, FDA approved Sirolimus as the first drug for the treatment of lymphatic smooth muscle hyperplasia (LAM), a rare invasive pulmonary disease, that mainly impacts fertile woman.