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FDA grants approval of Besponsa for acute lymphoblastic leukaemia
europeanpharmaceuticalreview
August 21, 2017
The FDA has approved Besponsa for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia…
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FDA provides new tools for tests to detect Zika virus infection
biospectrumasia
August 21, 2017
Serological tests are especially important because there is often a small window when the virus' genetic material is detectable.
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FDA recalls liquid pharma products after bacterial contamination detected
pharmafile
August 18, 2017
The FDA has announced that it has been forced to recall a range of liquid pharmaceutical and dietary supplement products due a possible bacterial contamination which could pose a threat to vulnerable patients through threat of serious infection.
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FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukemia
worldpharmanews
August 18, 2017
The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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FDA Approves Besponsa for Relapsed or Refractory ALL
americanpharmaceuticalreview
August 18, 2017
The U.S. Food and Drug Administration approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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FDA Accepts Medivir´s IND Application for MIV-711
americanpharmaceuticalreview
August 17, 2017
Medivir announces the Investigational New Drug (IND) application for MIV-711 has been accepted and the IND is now open with the FDA (U.S. Food and Drug Administration).
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Accelerated drugs approval evaluated
europeanpharmaceuticalreview
August 17, 2017
Researchers have evaluate the features of pre-approval and post-approval clinical trials of drugs granted Accelerated Approval by the FDA…
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FDA Warns of Potential Contamination in Multiple Brands of Drugs, Dietary Supplements
americanpharmaceuticalreview
August 15, 2017
The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech and labeled by Rugby Laboratories, Major Pharmaceuticals and Leader Brands, due
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Drug approval harmonisation shows savings potential
europeanpharmaceuticalreview
August 15, 2017
Researchers have compared the regulatory authorities responsible for approving drugs and medical products to verify their effectiveness and safety…
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Natco gets US FDA nod to market renal disease drug
expressbpd
August 15, 2017
The product, as the first generic, will be launched shortly in the US market