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 ...

Read more →

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 ...

Read more →

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18 September 2019 - Today, the Food and Drug Administration issued draft guidance titled “Safer Technologies Program for Medical Devices,” ...

Read more →

Three-year-old Matilda's ability to walk is giving hope to those with spinal muscular atrophy

18 September 2019 - The disease, which has been described as motor neurone disease for children, is the leading cause of ...

Read more →

NICE recommends Takhzyro

18 September 2019 - NICE - a health technology appraisal body in England and Wales - has recommended the use ...

Read more →

'A child's health should not be a postcode lottery': anger of cystic fibrosis sufferers forced to pay £20,000 for drug abroad

17 September 2019 - Patients have formed a buyers' club to source a version of Orkambi after the drug's manufacturer and ...

Read more →

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 ...

Read more →

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. ...

Read more →

Biofrontera files label extension for Ameluz in EU to include treatment of actinic keratosis on extremities and trunk/neck

17 September 2019 - Biofrontera has filed a label extension for Ameluz with the EMA on August 28, 2019 to include ...

Read more →

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 ...

Read more →

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 ...

Read more →

Provisional approval of lenvatinib in combination with pembrolizumab for the treatment of advanced endometrial carcinoma

18 September 2019 - The Therapeutic Goods Administration has provisionally approved the use of lenvatinib (Lenvima) in combination with pembrolizumab ...

Read more →

Price controls for Medicare don't put America first

17 September 2019 - Instead of embracing drug price controls, the U.S. should pressure other nations to abandon them. ...

Read more →

News NHS England explores funding options for cystic fibrosis drug

17 September 2019 - NHS England is “committed to exploring and developing alternative routes” to enable people with cystic fibrosis ...

Read more →

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.  ...

Read more →

Does anyone really ‘love’ private health insurance?

17 September 2019 - I am alive today not because of insurance companies but despite them. ...

Read more →