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FDA OKs Novocures Optune Pax for Advanced Pancreatic Cancer

[ Price : $8.95]

FDA approves Novocures Optune Pax for use in combination with gemcitabine and nab-paclitaxel for adults with locally advanced panc...

Inhaled Gene Therapy for Lung Cancer Gets Expedited Status

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FDA awards Krystal Biotech a Regenerative Medicine Advanced Therapy designation for KB707, an inhalable gene therapy being investi...

Keytruda Regimen for PD-L1Positive Ovarian Cancers Approved

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FDA approves Mercks Keytruda (pembrolizumab), as well as the fixed-dose combination pembrolizumab and berahyaluronidase alfa-pmph ...

FDA Tags Data Integrity, Inventory Lapses in AGC Biologics 483

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FDA cites AGC Biologics for deficiencies in laboratory data controls and inventory management at its Bothell, WA, drug substance m...

Biofrontera sNDA Seeks Expanded Ameluz Use

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FDA accepts for review a Biofrontera supplemental NDA seeking to expand the label of its photodynamic therapy drug Ameluz (aminole...

Draft Guide on Medical Gases

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FDA posts a draft guidance entitled Certification Process for Designated Medical Gases.

FDA Hits Tremfya TV Ad as False or Misleading

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The CDER Office of Prescription Drug Promotion cautions Janssen Biotech about a direct-to-consumer TV ad for Tremfya that misleadi...

Rejection of Myopia Drug Raises Questions About Regulatory Consistency

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A Washington Post opinion article takes issue with FDAs recent decision to reject a low-dose atropine treatment for pediatric myop...

Commissioners Voucher Program Q&A Published

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FDA moves to blunt criticism of the Commissioners National Priority Voucher Program with a news release containing 18 questions an...

No Informed Consent in 2 Clinical Investigations: FDA

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FDA warns Mark Dacey of Denver, CO, about failing to obtain informed consent for two clinical investigations he conducted.