Blog
RSS FeedPosted by Michael Wonder on 10 May 2022
Eisai completes rolling submission to the U.S. FDA for biologics license application of lecanemab for early Alzheimer's disease under the accelerated approval pathway
10 May 2022 - Eisai and Biogen announced today that Eisai has completed the rolling submission to the U.S. FDA of ...
Posted by Michael Wonder on 08 May 2022
Wearable technology promises to revolutionise health care
5 May 2022 - Do not let bureaucracy delay matters. ...
Posted by Michael Wonder on 08 May 2022
Myovant & Pfizer provide update on supplemental new drug application for Myfembree for the management of moderate to severe pain associated with endometriosis
6 May 2022 - Myovant Sciences & Pfizer announced today that the U.S. FDA has extended the review period for the ...
Posted by Michael Wonder on 07 May 2022
FDA limits use of Janssen COVID-19 vaccine to certain individuals
5 May 2022 - Today, the U.S. FDA has limited the authorised use of the Janssen COVID-19 Vaccine to individuals ...
Posted by Michael Wonder on 06 May 2022
Congress moves toward reforming FDA accelerated approvals, but with pharma friendly concessions
4 May 2022 - House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s ...
Posted by Michael Wonder on 06 May 2022
Patient reported outcome assessment must be inclusive and equitable
5 May 2022 - Patient reported outcomes are increasingly collected in clinical trials and in routine clinical practice, but strategies ...
Posted by Michael Wonder on 05 May 2022
FDA Commissioner Califf says business of health is booming in U.S. but patients’ outcomes aren’t improving
4 May 2022 - At a hearing last month, FDA Commissioner Robert Califf pointed to the fact that the U.S. ...
Posted by Michael Wonder on 05 May 2022
FDA's use of adcomms prior to drug approval decreased over the last decade
3 May 2022 - Between 2011 and 2021, the U.S. FDA decreased the use of advisory committees before approving drugs from ...
Posted by Michael Wonder on 05 May 2022
Enhertu approved in the US for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen
5 May 2022 - Based on ground-breaking DESTINY-Breast03 results showing Enhertu reduced the risk of disease progression or death by ...
Posted by Michael Wonder on 05 May 2022
Real world evidence - where are we now?
4 May 2022 - Notwithstanding on-going confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 ...
Posted by Michael Wonder on 04 May 2022
FDA permits marketing for new test to improve diagnosis of Alzheimer’s disease
4 May 2022 - The U.S. FDA today permitted marketing for the firstin vitro diagnostic test for early detection ...
Posted by Michael Wonder on 04 May 2022
Aptose receives fast track designation for HM43239 in relapsed/refractory AML patients and FLT3 mutation
4 May 2022 - Aptose Biosciences today announced that the U.S. FDA has granted fast track designation to HM43239, an oral, ...
Posted by Michael Wonder on 04 May 2022
Phathom Pharmaceuticals announces FDA approval of Voquenza Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquenza Dual Pak (vonoprazan, amoxicillin) for the treatment of H. pylori infection in adults
3 May 2022 - U.S. commercial launch anticipated in the third quarter of 2022. ...
Posted by Michael Wonder on 04 May 2022
X-Therma receives FDA breakthrough device designation for XT-ViVo preservation solution and TimeSeal organ transport device
3 May 2022 - X-Therma announced today that the Center for Devices and Radiological Health of the FDA has granted ...
Posted by Michael Wonder on 04 May 2022
Mirvie receives FDA breakthrough device designation for first test designed to indicate risk of preeclampsia months before symptoms occur
3 May 2022 - Breakthrough has the potential to address a leading cause of maternal mortality that impacts millions of ...