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FDA accepts Roche’s BLA for emicizumab to treat Haemophilia A expressbpd
August 28, 2017
The US Food and Drug Administration (FDA) has accepted Roche’s biologics licence application (BLA) and granted priority review for emicizumab prophylaxis (preventative) to treat patients with haemophilia A with factor VIII inhibitors.
FDA, EMA and EC sign new confidentiality commitment pharmatimes
August 25, 2017
The US Food and Drug Administration can now share non-public and commercially confidential information, including trade secrets relating to medicines inspections, with EU regulators after the parties signed a new commitment.
Roche receives FDA Priority Review for drug with potted history pharmafile
August 25, 2017
Roche, alongside its subsidiary, Genentech, announced that it has received Priority Review for its haemophilia A drug, emicizumab, and that the agency has accepted its BLA.
FDA Grants Priority Review to Genentech’s Emicizumab for Hemophilia A with Inhibitors August 25, 2017
Genentech announced the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as a once-weekly subcutaneous treatment for adults, adoles
FDA evaluates prescription opioid medications approved for children europeanpharmaceuticalreview
August 23, 2017
The FDA has heard from professional groups, including the American Academy of Paediatrics about the use of opioid cough suppressants for children…
Zydus Cadila gets final US FDA nod for Pindolol tabs expressbpd
August 23, 2017
The drug will be manufacture at the groups manufacturing facility at the Pharma SEZ in Ahmedabad.
Lupin receives EIR from US FDA expressbpd
August 22, 2017
The company’s Aurangabad facility underwent inspection in April 2017
US FDA grants Lion TCR two orphan drug designations of T cell therapy against Hepatocellular Carcino biospectrumasia
August 22, 2017
Lion TCR are developing two product candidates -- HBV specific TCR redirected T cell therapies against HCC with transient mRNA and a longer lasting DNA transduction technology.
FDA expands use of AZ/Merck’s Lynparza in the US pharmatimes
August 21, 2017
AstraZeneca and Merck & Co’s Lynparza will be available to a wider range of patients in the US after regulators expanded the PARP inhibitor’s list of approved uses.
FDA grants two orphan drug designations for HCC europeanpharmaceuticalreview
August 21, 2017
The FDA has granted two orphan drug designations for T cell therapy products for the treatment of hepatocellular carcinoma…

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