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New Warning Letter from FDA
2016-10-28 19:53:00| Happi Breaking News
Osea flagged for drug claims following website review.
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warning letter
PASS Coalition To Meet with FDA
2016-10-28 03:05:00| Happi Breaking News
November 1, 2016.
FDA Proposes End to Exemptions for Certain Ozone Depleting Substances
2016-10-27 10:00:00| Expeditors Newsflash - Americas Edition
Expeditors Newsflash - Americas Edition
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FDA Approves Mercks KEYTRUDA (pembrolizumab) in Metastatic NSCLC for First-Line Treatment of Patients Whose Tumors Have High PD-L1 Expression (Tumor Proportion Score [TPS] of 50 Percent or More) With No EGFR or ALK Genomic Tumor Aberrations
2016-10-25 00:04:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. KEYTRUDA is the Only Anti-PD-1 Therapy Approved in First-Line Treatment of Metastatic NSCLC; KEYTRUDA Demonstrated Superior Progression-Free and Overall Survival Compared to Chemotherapy in Patients Whose Tumors Expressed High Levels of PD-L1 FDA Also Approves a Labeling Update for KEYTRUDA for the Treatment of Patients with Metastatic NSCLC Whose Tumors Express PD-L1 (TPS of One Percent or More) With 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 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab), the companys anti-PD-1 (programmed death receptor-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558Courtney Ronaldo, 908-236-1108orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
FDA Approves Mercks ZINPLAVA (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adult Patients Receiving Antibacterial Drug Treatment for CDI Who Are at High Risk of CDI Recurrence
2016-10-22 03:57:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved ZINPLAVA (bezlotoxumab) Injection 25 mg/mL. Merck anticipates making ZINPLAVA available in first quarter 2017. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orRobert Consalvo, 908-236-1127orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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