Accelerating the shift toward person-generated real world evidence

19 September 2019 - Evidence generated from randomised clinical trials and other clinical studies has long been the foundation for ...

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Merck’s Pifelto (doravirine) and Delstigo (doravirine/lamivudine/tenofovir disoproxil fumarate) receive US FDA approval for use in appropriate adults living with HIV-1 who are virologically suppressed

20 September 2019 - Approvals based on findings from the Phase 3 DRIVE-SHIFT Trial evaluating a switch to Delstrigo. ...

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FDA approves first oral GLP-1 treatment for type 2 diabetes

20 September 2019 - The U.S. FDA today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult ...

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SanBio granted regenerative medicine advanced therapy designation from the U.S. FDA for SB623 for the treatment of chronic neurological motor deficits secondary to traumatic brain injury

19 September 2019 - The SanBio Group today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation ...

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FDA continues to take steps to fulfil its commitment to strengthen and modernise the 510(k) medical device program

19 September 2019 - The U.S. FDA today announced that, as a first step toward implementation of the recently established Safety ...

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FDA grants fast track designation for SPI-1005 in the treatment of Meniere's disease

18 September 2019 - Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request ...

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FDA issues final guidance to address ‘gaming’ by the use of citizen petitions

18 September 2019 - Today the U.S. FDA issued the final guidance, Citizen Petitions and Petitions for Stay of Action Subject ...

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FDA continues steps to promote innovation in medical devices that help advance patient safety through the Safer Technologies Program

18 September 2019 - Today, the Food and Drug Administration issued draft guidance titled “Safer Technologies Program for Medical Devices,” ...

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Susan G. Komen Big Data for Breast Cancer Initiative: how patient advocacy organisations can facilitate using big data to improve patient outcomes

12 September 2019 - Integrating different types of data, including electronic health records, imaging data, administrative and claims databases, large data ...

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FDA grants breakthrough therapy designation for Roche’s Gazyva (obinutuzumab) in lupus nephritis

18 September 2019 - There are currently no U.S. FDA approved medicines for lupus nephritis. ...

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Vertical Pharmaceuticals announces submission of new drug application for RVL-1201

17 September 2019 - Vertical Pharmaceuticals today announced the submission of a new drug application to the U.S. FDA for ...

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U.S. FDA approves supplemental new drug application for Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer

17 September 2019 - Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of ...

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FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

17 September 2019 - The U.S. FDA is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence.  ...

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FDA accepts Merck’s biologics license application and grants priority review for V920, the company’s investigational vaccine for Ebola Zaire virus

17 September 2019 - Merck continues to expand investigational supply to support international Ebola outbreak response. ...

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FDA seeks input on product-specific guidances to facilitate generic drug development

16 September 2019 - Today, FDA published 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised guidances, including ...

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