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RSS FeedPosted 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
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 ...
Posted by Michael Wonder on 08 Apr 2021
Dying patients wait in vain after Trump-era easing of drug law
6 April 2021 - Companies hold back experimental medications from those who want them most. They say they have good reasons, ...
Posted by Michael Wonder on 07 Apr 2021
FDA approves new dosing regimen for cetuximab
7 April 2021 - On 6 April 2021, the FDA approved a new dosage regimen of 500 mg/m2 as a ...
Posted by Michael Wonder on 07 Apr 2021
Hanmi's short bowel syndrome drug gets FDA fast track status
7 April 2021 - Hanmi Pharmaceutical said Wednesday that the U.S. Food and Drug Administration has granted fast-track designation to ...
Posted by Michael Wonder on 07 Apr 2021
FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer
7 April 2021 - Today the FDA granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics) for patients with unresectable locally ...
Posted by Michael Wonder on 07 Apr 2021
AbbVie submits regulatory applications for Skyrizi (risankizumab) in psoriatic arthritis to FDA and EMA
7 April 2021 - Submissions supported by two Phase 3 studies in patients with active psoriatic arthritis in which Skyrizi demonstrated ...
Posted by Michael Wonder on 07 Apr 2021
Pfizer announces extension of review of new drug application of abrocitinib for the treatment of moderate to severe atopic dermatitis
7 April 2021 - Pfizer today announced that the U.S. FDA has extended the priority review period for the new ...
Posted by Michael Wonder on 07 Apr 2021
IceCure Medical granted FDA breakthrough device designation for Prosense cryoablation system
5 April 2021 - IceCure Medical announced today that it has been granted designation as a breakthrough device from the ...
Posted by Michael Wonder on 07 Apr 2021
FDA approves Althera’s Roszet (rosuvastatin and ezetimibe) tablets, a new oral therapy for powerful cholesterol reduction
31 March 2021 - Roszet is indicated for adults with primary non-familial hyperlipidaemia and homozygous familial hypercholesterolaemia. ...
Posted by Michael Wonder on 07 Apr 2021
Rare Disease Therapeutics announces new expanded FDA approved indication for antivenom Anavip for treatment of North American Pit Viper envenomation
5 April 2021 - Anavip now indicated for management of adult and paediatric patients with all North American Pit Viper envenomation, ...
Posted by Michael Wonder on 06 Apr 2021
Lilly and Incyte communicate review extension of supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis
6 April 2021 - Eli Lilly and Incyte announced today that the U.S. FDA has extended the review period for ...
Posted by Michael Wonder on 06 Apr 2021
FDA makes two revisions to Moderna COVID-19 vaccine emergency use authorization to help increase the number of vaccine doses available
1 April 2021 - Today, the U.S. FDA announced two revisions regarding the number of doses per vial available for the ...