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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CHMP recommends approval of Dupixent (dupilumab) for severe chronic rhinosinusitis with nasal polyposis

20 September 2019 - The EMA’s CHMP has adopted a positive opinion for Dupixent®(dupilumab) in a third indication.  ...

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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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Astellas receives positive CHMP opinion for Xospata (gilteritinib) as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation

20 September 2019 - If approved by the European Commission, gilteritinib would represent one of the few advances in Europe for ...

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CHMP adopts positive opinion for Bavencio (avelumab) plus axitinib for first-line treatment of patients with advanced renal cell carcinoma

20 September 2019 - Opinion based on Phase III data showing combination lowered risk of disease progression or death by 31% ...

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Highlights from the CHMP 16-19 September 2019 meeting

20 September 2019 - Seven new medicines recommended for approval. ...

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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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Emmaus Life Sciences announces withdrawal of marketing authorisation application to European Medicines Agency

19 September 2019 - Emmaus Life Sciences today announced the withdrawal of its marketing authorisation application to the European Medicines ...

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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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Novartis has submitted application to EMA for approval of Cosentyx in nr-axSpA, which would be the fourth indication

17 September 2019 - 52-week data from the PREVENT study, to support FDA submission, are expected later in the year. ...

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Flawed evidence underpins approval of new cancer drugs

18 September 2019 - We must raise the bar to ensure real benefits for patients ...

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Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis

18 September 2019 - In this study, the investigators examined the characteristics of randomised controlled trials that supported approval of cancer ...

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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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