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RSS FeedPosted by Michael Wonder on 22 Feb 2021
EMA plots earlier engagement with patient groups
19 February 2021 - The EMA on Friday announced it will pilot an early engagement program to bring patient and ...
Posted by Michael Wonder on 22 Feb 2021
Intra-Cellular Therapies applies for FDA approval of Caplyta (lumateperone) for the treatment of bipolar depression
22 February 2021 - If approved, Caplyta has the potential to treat the broadest range of patients with bipolar depression. ...
Posted by Michael Wonder on 22 Feb 2021
Supernus receives FDA notice assigning early April 2021 PDUFA date for SPN-812 NDA
22 February 2021 - Supernus Pharmaceuticals today announced that it received notice from the U.S. FDA that the company’s new drug ...
Posted by Michael Wonder on 22 Feb 2021
Celsion Corporation receives FDA fast track designation for GEN-1 in advanced ovarian cancer
22 February 2021 - Designation provides potential for an expedited regulatory review.. ...
Posted by Michael Wonder on 22 Feb 2021
FDA outlines fast path for shots against new virus variants
23 February 2021 - Variants are already causing problems for testing, treatment. ...
Posted by Michael Wonder on 22 Feb 2021
FDA approves Libtayo (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%
22 February 2021 - This is the third approval for Libtayo in the U.S. ...
Posted by Michael Wonder on 22 Feb 2021
Voluntary withdrawal of Imfinzi indication in advanced bladder cancer in the US
22 February 2021 - AstraZeneca today announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated ...
Posted by Michael Wonder on 21 Feb 2021
The price of success—how to evaluate COVID-19 vaccines when they’re available outside of clinical trials
20 February 2021 - In science, as in other fields of endeavour, success can have unexpected consequences. ...
Posted by Michael Wonder on 21 Feb 2021
von der Leyen admits to COVID-19 vaccine failures
20 February 2021 - EU Commission President Ursula von der Leyen's comments come after much scrutiny of the EU vaccination ...
Posted by Michael Wonder on 20 Feb 2021
Who will be the next FDA chief?
20 February 2021 - Two leading contenders generate wider debate about the leadership needed to restore morale and scientific integrity to ...
Posted by Michael Wonder on 20 Feb 2021
Dynavax announces European Commission marketing authorization for Heplisav B, a two dose adult hepatitis B adjuvanted vaccine
19 February 2021 - Approval based on safety and immunogenicity results from three Phase 3 clinical trials. ...
Posted by Michael Wonder on 20 Feb 2021
Incyte announces acceptance and priority review of NDA for ruxolitinib cream for atopic dermatitis
19 February 2021 - Incyte today announced that the U.S. FDA has accepted for priority review the new drug application for ...
Posted by Michael Wonder on 20 Feb 2021
Pfizer and BioNTech submit COVID-19 vaccine stability data at standard freezer temperature to the U.S. FDA
19 February 2021 - Pfizer and BioNTech today announced the submission of new data to the U.S. FDA demonstrating the stability ...
Posted by Michael Wonder on 20 Feb 2021
Immunocore’s tebentafusp granted breakthrough therapy designation for unresectable or metastatic uveal melanoma from FDA
19 February 2021 - Submission of a biologic license application to FDA planned for Q3 2021. ...
Posted by Michael Wonder on 20 Feb 2021
Confusion over Russia's EU vaccine approval bid could be result of misdirected application
20 February 2021 - Russia’s submission of its Sputnik V vaccine for approval by the European Union’s medicines regulator appears ...