Blog
RSS FeedPosted by Michael Wonder on 16 Feb 2021
Jazz Pharmaceuticals completes submission of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for idiopathic hypersomnia
16 February 2021 - Jazz Pharmaceuticals today announced the completion of the rolling submission for the supplemental new drug application to ...
Posted by Michael Wonder on 16 Feb 2021
Forge Biologics receives FDA fast track, orphan drug, and rare paediatric disease designations for FBX-101 gene therapy for patients with Krabbe disease
16 February 2021 - FBX-101 is a first-in-human gene therapy utilising an adeno-associated virus to deliver a functioning copy of the ...
Posted by Michael Wonder on 16 Feb 2021
After a controversial Alzheimer’s drug review, FDA’s Woodcock rejects proposal to ‘firewall’ agency and drug companies
16 February 2021 - In response to criticism, a top FDA official maintained that creating a firewall between agency staff ...
Posted by Michael Wonder on 16 Feb 2021
Sesen Bio announces FDA acceptance and priority review of its biologics license application for Vicineum
16 February 2021 - FDA stated it is not currently planning to hold an advisory committee meeting. ...
Posted by Michael Wonder on 16 Feb 2021
Novartis Entresto granted expanded indication in chronic heart failure by FDA
16 February 2021 - Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined ...
Posted by Michael Wonder on 16 Feb 2021
The US regulatory system and COVID-19 vaccines: the importance of a strong and capable FDA
15 February 2021 - For many in public health and medicine, the coronavirus disease 2019 (COVID-19) pandemic in the US has ...
Posted by Michael Wonder on 15 Feb 2021
Targovax receives fast track designation for ONCOS-102
15 February 2021 - Targovax today announces that its lead clinical candidate ONCOS-102 has received fast track designation in malignant ...
Posted by Michael Wonder on 15 Feb 2021
Polaryx Therapeutics receives both rare paediatric disease and orphan drug designations for the treatment of Krabbe disease with PLX-300
10 February 2021 - Polaryx Therapeutics announced today that it has received both rare paediatric disease and orphan drug designations for ...
Posted by Michael Wonder on 15 Feb 2021
It’s time to fast track innovation in medical devices for children
11 February 2021 - When a baby arrived at Children’s National Hospital with a critically underdeveloped heart, it was clear ...
Posted by Michael Wonder on 14 Feb 2021
Assessment of FDA and EMA approved systemic oncology therapies and clinically meaningful improvements in quality of life
11 February 2021 - Are oncology therapies recently approved by the US FDA and the EMA associated with clinically meaningful improvements ...
Posted by Michael Wonder on 14 Feb 2021
Mallinckrodt provides regulatory update on StrataGraft
12 February 2021 - Mallinckrodt today announced that the U.S. FDA has informed the Company that it is deferring action ...
Posted by Michael Wonder on 14 Feb 2021
FDA approves drug to reduce bone marrow suppression caused by chemotherapy
12 February 2021 - Today, the U.S. FDA approved Cosela (trilaciclib) as the first therapy in its class to reduce the ...
Posted by Michael Wonder on 14 Feb 2021
U.S. FDA approves Panzyga for the treatment of adults with chronic inflammatory demyelinating polyneuropathy
12 February 2021 - The first and only FDA approved intravenous immunoglobulin with two maintenance dosing options for chronic inflammatory ...
Posted by Michael Wonder on 12 Feb 2021
Rescindo Therapeutics’ RSC-57 receives FDA orphan drug designation and rare paediatric disease designation for Kabuki syndrome
12 February 2021 - Rescindo Therapeutics announced today that the U.S. FDA has granted orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 11 Feb 2021
BrainCool receives FDA breakthrough device designation for Cooral System for prevention of oral mucositis
11 February 2021 - Recent Medicare reimbursement ruling provides an additional boost in paving the way for elimination of one of ...