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RSS FeedPosted by Michael Wonder on 22 Jan 2019
Shutdown risks delaying FDA approval of potentially life-saving drugs and therapies
22 January 2019 - It's not accepting new applications or fees during the shutdown. ...
Posted by Michael Wonder on 22 Jan 2019
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on latest steps to strengthen FDA’s 510(k) program for premarket review of medical devices
22 January 2019 - In 2018, the FDA’s Center for Devices and Radiological Health achieved several new milestones, including a ...
Posted by Michael Wonder on 22 Jan 2019
FDA chief Scott Gottlieb warns 'we have many hard decisions ahead of us' if government shutdown persists
18 January 2019 - "We are in uncharted territory. This is a watershed moment in the life of this agency," he ...
Posted by Michael Wonder on 22 Jan 2019
Vertex announces European Commission approval for Orkambi (lumacaftor/ivacaftor) for treatment of children with cystic fibrosis aged 2 to 5 years old with most common form of the disease
21 January 2019 - Lumacaftor/ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic ...
Posted by Michael Wonder on 22 Jan 2019
Sandoz Canada receives Health Canada approval for Erelzi (etanercept) in the treatment of psoriatic arthritis in adult patients
21 January 2019 - Erelzi is the only etanercept biosimilar to be indicated for reducing the signs and symptoms of psoriatic ...
Posted by Michael Wonder on 22 Jan 2019
Sanofi UK marketing authorisation granted for Sanofi Pasteur’s trivalent influenza vaccine (split virion, inactivated) high dose (TIV high dose)
21 January 2019 - UK is the only European country where TIV high dose is approved. ...
Posted by Michael Wonder on 21 Jan 2019
Europe closer to biosimilar rule change, despite fierce resistance from pharma
18 January 2019 - EFPIA says it weakens IP commitment - supporters say it will boost exports. ...
Posted by Michael Wonder on 21 Jan 2019
FDA's banner year for approvals: will market access to new drugs follow suit?
21 January 2019 - It's not hyperbolic to say that 2018 was a sensational year for FDA approvals of new drugs ...
Posted by Michael Wonder on 19 Jan 2019
Samsung Bioepis biosimilar to Roche's Herceptin wins FDA nod
19 January 2019 - The U.S. FDA said on Friday it had approved a biosimilar to Roche’s blockbuster breast cancer ...
Posted by Michael Wonder on 18 Jan 2019
Lilly reports results of Phase 3 soft tissue sarcoma study of Lartruvo
18 January 2019 - Lartruvo in combination with doxorubicin previously showed an overall survival benefit in soft tissue sarcoma in a ...
Posted by Michael Wonder on 18 Jan 2019
Immunomedics receives complete response letter from FDA for sacituzumab govitecan biologics license application
17 January 2019 - Immunomedics today announced it has received a complete response letter from the U.S. FDA for the ...
Posted by Michael Wonder on 18 Jan 2019
Actelion receives complete response letter from U.S. FDA for Opsumit (macitentan) supplemental new drug application
16 January 2019 - Actelion today announced it has received a complete response letter from the U.S. FDA for its supplemental ...
Posted by Michael Wonder on 18 Jan 2019
FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy (Abraxane and carboplatin) for the initial treatment of metastatic non-squamous non-small cell lung cancer
17 January 2019 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application for Tecentriq ...
Posted by Michael Wonder on 17 Jan 2019
FDA issues letter about paclitaxel coated balloons and eluting stents
17 January 2019 - Today the FDA issued a letter to health care providers about a recent publication in the Journal ...
Posted by Michael Wonder on 17 Jan 2019
FDA updates guidance on development of rare disease therapies
17 January 2019 - The FDA has revised its draft guidance for developing rare disease treatments to include the use ...