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FDA Approves Peanut Allergy Claim on Baby Food

2017-09-11 22:49:00| Food Processing

The new claim on food labels will recommend parents check with their infants healthcare provider before introducing foods containing ground peanuts.

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FDA approves first pain control medication for food-producing animal

2017-07-26 01:55:00| Beef

Banamine Transdermal is first new animal drug approved in U.S. for controlling pain in cattle.

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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

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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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FDA Approves Mercks KEYTRUDA (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy

2016-08-08 12:45:00| Merck.com - Product 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 KEYTRUDA (pembrolizumab), the companys anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orAn Phan, 908-255-6325orInvestor:Teri Loxam, 908-740-1898orAmy Klug, 908-740-1898 Ticker Slug: Ticker: MRK Exchange: NYSE read more

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