Blog
RSS FeedPosted by Michael Wonder on 27 Nov 2018
Statement from FDA Commissioner on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
27 November 2018 - Earlier this week, the FDA announced new steps to modernise FDA’s 510(k) clearance pathway, used for ...
Posted by Michael Wonder on 27 Nov 2018
FDA promised a ‘lower-cost option’ to EpiPen, but the price isn’t any lower
27 November 2018 - Teva's alternative to Mylan's authorised generic EpiPen is no cheaper. ...
Posted by Michael Wonder on 27 Nov 2018
Loxo and Bayer's amazing drug has an expensive price
26 November 2018 - A little more than a year ago, I wrote the story of a cancer drug developed by ...
Posted by Michael Wonder on 27 Nov 2018
Perrigo announces tentative FDA approval for the first to file generic version of Ultravate lotion 0.05%
26 November 2018 - Perrigo today announced it has received tentative approval from the U.S. FDA for the first to ...
Posted by Michael Wonder on 27 Nov 2018
Biohaven announces FDA acceptance of 505(B)(2) NDA filing for BHV-0223, a novel sublingual form of riluzole for the treatment of amyotrophic lateral sclerosis
26 November 2018 - If approved, BHV-0223 would become the only formulation of riluzole that does not require swallowing tablets or ...
Posted by Michael Wonder on 27 Nov 2018
FDA approves the ACTpen for Genentech’s Actemra, a single-dose, pre-filled auto-injector for the treatment of rheumatoid arthritis, giant cell arteritis and two forms of juvenile arthritis
26 November 2018 - Genentech announced today that the U.S. FDA has approved ACTPen 162 mg/0.9 mL, a single-dose pre-filled auto-injector ...
Posted by Michael Wonder on 26 Nov 2018
FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumour
26 November 2018 - The U.S. FDA today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and paediatric ...
Posted by Michael Wonder on 26 Nov 2018
Statement from FDA Commissioner and Director of the Center for Devices and Radiological Health on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices
26 November 2018 - Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of ...
Posted by Michael Wonder on 26 Nov 2018
SK Biopharmaceuticals submits epilepsy drug candidate for approval to US FDA
26 November 2018 - SK Biopharmaceuticals, the new drug development unit of South Korea’s telecom-to-energy conglomerate SK Group, said Monday ...
Posted by Michael Wonder on 26 Nov 2018
Migraine patients’ coverage headache: FDA OK doesn’t mean insurance will pay
25 November 2018 - Last spring, weeks before the new migraine drug Aimovig hit the market, the phone calls and ...
Posted by Michael Wonder on 23 Nov 2018
FDA is advancing new efforts to address drug shortages
19 November 2018 - A key component of our public health mission is to help ensure Americans have access to ...
Posted by Michael Wonder on 22 Nov 2018
40 million people with diabetes will be left without insulin by 2030, study predicts
22 November 2018 - As the number of people living with diabetes continues to rise, the access to insulin needed ...
Posted by Michael Wonder on 22 Nov 2018
Allergan announces FDA acceptance of supplemental new drug application for Avycaz (ceftazidime and avibactam)
20 November 2018 - Application seeks to expand the Avycaz label to include treatment of cUTI and cIAI in paediatric ...
Posted by Michael Wonder on 22 Nov 2018
FDA grants priority review for Daiichi Sankyo’s new drug application for FLT3 inhibitor quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
22 November 2018 - Quizartinib marketing applications now under expedited review in the U.S., Japan and EU. ...
Posted by Michael Wonder on 21 Nov 2018
IntelGenx announces FDA’s acceptance of resubmission of new drug application for Rizaport
20 November 2018 - PDUFA goal date of 1 April 2019. ...