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RSS FeedPosted by Michael Wonder on 12 Apr 2021
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in idiopathic hypersomnia
12 April 2021 - Final FDA decision anticipated by 12 August. ...
Posted by Michael Wonder on 12 Apr 2021
FDA approves Xolair (omalizumab) pre-filled syringe for self-injection across all indications
12 April 2021 - Xolair for self-injection offers health care providers and appropriate patients another administration option for more flexibility in ...
Posted by Michael Wonder on 12 Apr 2021
FibroGen receives fast track designation from the U.S. FDA for pamrevlumab for the treatment of Duchenne muscular dystrophy
12 April 2021 - FibroGen announced that the U.S. FDA has granted fast track designation for the company’s anti-CTGF antibody, pamrevlumab, ...
Posted by Michael Wonder on 10 Apr 2021
Johnson & Johnson COVID-19 vaccine under review by EMA over blood clots
10 April 2021 - Europe’s drug regulator says it is reviewing rare blood clots in four people in the United States ...
Posted by Michael Wonder on 10 Apr 2021
Doctors stop offering AstraZeneca jabs over legal risk
11 April 2021 - Many of the nation’s GPs are refusing to offer AstraZeneca’s vaccine to people under 50 until ...
Posted by Michael Wonder on 10 Apr 2021
Scilex has received from FDA a sNDA approval for ZTlido label expansion
9 April 2021 - Scilex has received a supplemental new drug application approval from the FDA for ZTlido to make ...
Posted by Michael Wonder on 09 Apr 2021
Pfizer requests FDA clearance for vaccine in kids ages 12 to 15
9 April 2021 - The FDA's review process will probably take several weeks, experts say. The move would make Pfizer's vaccine ...
Posted by Michael Wonder on 09 Apr 2021
FDA authorises marketing of first device that uses artificial intelligence to help detect potential signs of colon cancer
9 April 2021 - Medical device aids clinicians in detecting potential irregularities during colon cancer screening and surveillance. ...
Posted by Michael Wonder on 09 Apr 2021
Genmab and Seagen announce U.S. FDA filing acceptance for priority review of tisotumab vedotin biologics license application for patients with recurrent or metastatic cervical cancer
9 April 2021 - BLA submission supported by positive pivotal innovaTV 204 trial results presented at the European Society of Medical ...
Posted by Michael Wonder on 09 Apr 2021
Provention Bio provides regulatory update on biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals
8 April 2021 - Provention Bio today announced that the company received a notification on 2 April 2021 from the U.S. ...
Posted by Michael Wonder on 08 Apr 2021
ATAGI statement on AstraZeneca vaccine in response to new vaccine safety concerns
8 April 2021 - A statement from the Australian Technical Advisory Group on Immunisation (ATAGI) on the AstraZeneca COVID-19 vaccine in ...
Posted by Michael Wonder on 08 Apr 2021
Teva Canada announces new auto-injector for Ajovy for the preventive treatment of migraine in adults
8 April 2021 - Ajovy now offers patients greater flexibility with two dosing options available in both an auto-injector and a ...
Posted by Michael Wonder on 08 Apr 2021
‘Before end of this year’: Novavax COVID vaccine could be months away
8 April 2021 - Regulatory approvals for the third pillar of Australia’s vaccine strategy may not be obtained until the ...
Posted by Michael Wonder on 08 Apr 2021
AstraZeneca worldwide: who’s using the jab, and who’s not
9 April 2021 - A growing list of countries are either restricting or suspending the use of AstraZeneca vaccine amid it’s ...
Posted by Michael Wonder on 08 Apr 2021
Immutep achieves fast track designation from US FDA for EFTI, a soluble LAG-3 protein, in first-line recurrent/metastatic head & neck cancer
8 April 2021 - Fast track was granted based on the promising data package from Immutep, including from Immutep’s Phase ...