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FDA issues warning letter which highlights the importance of a quality unit europeanpharmaceuticalreview
January 07, 2020
Henan Kangdi Medical Devices Co Ltd has been sent a warner letter after an inspection found cGMP violations that included failures of the company’s quality unit.
AstraZeneca secures FDA priority review for Farxiga pharmaceutical-technology
January 07, 2020
AstraZeneca has secured the US Food and Drug Administration (FDA) priority review for Farxiga (dapagliflozin) to treat heart failure with reduced ejection fraction (HFrEF).
Dr. Nalini Rajamannan Comments on FDA Congressional Letter to Senate Finance Committee After Kaiser Health News Reveals Access to Exempt FDA Database prnasia
January 06, 2020
A recent investigation by Kaiser Health News has exposed a myriad of issues with the FDA's reporting laws for "exempt" medical devices. The decades-long practice of "filing for exemption" allowed medical device makers to conceal millions of device reports
Lab finds NDMA in Zantac can develop during storage fiercepharma
January 06, 2020
Another testing lab has jumped into the Zantac impurity fray and urged the FDA to recall all ranitidine drugs.
FDA announces US recall of mirtazapine tablets due to mislabelled strength europeanpharmaceuticalreview
January 06, 2020
Aurobindo Pharma USA, Inc. has issued a voluntary nationwide recall of certain mirtazapine tablets as bottles labelled as 7.5mg may contain 15mg tablets.
AZ, Merck's Lynparza lands FDA nod in pancreatic cancer fiercepharma
January 03, 2020
Earlier this month, FDA experts voted—barely—that the agency should approve AstraZeneca and Merck’s Lynparza in pancreatic cancer.
FDA Approves New Drug, PADCEV to Treat Locally Advanced or Metastatic Urothelial Cancer Lin Zhang
January 03, 2020
A new drug, PADCEV (enfortumab vedotin-ejfv) to treat patients with locally advanced or metastatic urothelial cancer, was approved under the FDA’s Accelerated Approval Program based on tumor response rate.
FDA Approves olaparib for gBRCAm Metastatic Pancreatic Adenocarcinoma americanpharmaceuticalreview
January 03, 2020
The U.S. Food and Drug Administration (FDA) has approved olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals) for the maintenance treatment of adult patients with deleterious or ...
Novadoz Pharmaceuticals receives FDA go-ahead for Febuxostat generic europeanpharmaceuticalreview
January 03, 2020
Novodoz Pharmaceuticals is the sales and marketing subsidiary of MSN Labs – a leader in the production and supply of APIs (active pharmaceutical ingredients) to ...
Lynparza approved by FDA to treat germline BRCA-mutated metastatic pancreatic cancer europeanpharmaceuticalreview
January 03, 2020
The FDA has approved Lynparza as a first-line treatment after it reduced the risk of disease progression or death by 47 percent in patients.

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