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RSS FeedPosted by Michael Wonder on 30 Apr 2021
FDA approves treatment for chronic kidney disease
30 April 2021 - Approval is first to cover many causes of disease. ...
Posted by Michael Wonder on 30 Apr 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) as adjuvant treatment for patients with muscle-invasive urothelial carcinoma
30 April 2021 - Application based on Phase 3 CheckMate-274 trial, in which Opdivo nearly doubled disease-free survival compared to placebo. ...
Posted by Michael Wonder on 30 Apr 2021
Update on U.S. FDA review of LEO Pharma’s biologics license application for tralokinumab for the treatment of adults with moderate to severe atopic dermatitis
29 April 2021 - FDA has requested additional data relating to a device component of tralokinumab. ...
Posted by Michael Wonder on 30 Apr 2021
Bristol Myers Squibb statement on FDA Advisory Committee meeting on Opdivo post sorafenib hepatocellular carcinoma U.S. indication
29 April 2021 - As part of its industry-wide review of accelerated approvals in oncology without confirmatory benefit, the U.S ...
Posted by Michael Wonder on 30 Apr 2021
AstraZeneca struggles with data needed for COVID-19 vaccine’s approval
29 April 2021 - Company is assembling data for FDA review, hoping for another stamp of regulatory backing in global rollout ...
Posted by Michael Wonder on 30 Apr 2021
Cerapedics announces FDA breakthrough device designation granted for P-15L bone graft for the treatment of degenerative disc disease
29 April 2021 - P-15L bone graft is currently being studied in the Company's ASPIRE IDE clinical trial. ...
Posted by Michael Wonder on 29 Apr 2021
FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for previously untreated metastatic bladder cancer
28 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 10 to 1 in favour of ...
Posted by Michael Wonder on 29 Apr 2021
Biogen provides regulatory update on the supplemental biologic license application for subcutaneous administration of Tysabri (natalizumab)
28 April 2021 - Biogen today announced that it has received a complete response letter from the U.S. FDA for ...
Posted by Michael Wonder on 28 Apr 2021
FDA takes action for failure to submit required clinical trial results information to ClinicalTrials.gov
28 April 2021 - Being transparent about the results of completed clinical trials enables important advances in the development of medical ...
Posted by Michael Wonder on 28 Apr 2021
Akari Therapeutics receives FDA fast track designation for nomacopan for the treatment of bullous pemphigoid
28 April 2021 - A multicenter Phase 3 trial of nomacopan for the treatment of moderate and severe bullous pemphigoid has ...
Posted by Michael Wonder on 28 Apr 2021
FDA grants priority review for Nefecon for patients with IgA nephropathy
28 April 2021 - Calliditas Therapeutics today announced that the U.S. FDA has accepted the submission and granted priority review for ...
Posted by Michael Wonder on 28 Apr 2021
Protalix BioTherapeutics and Chiesi Global Rare Diseases receive complete response letter for pegunigalsidase alfa from FDA
28 April 2021 - Protalix BioTherapeutics and Chiesi Global Rare Diseases today announced that they received a complete response letter from ...
Posted by Michael Wonder on 28 Apr 2021
Biogen to expand access to its ALS drug, but move may come too late for some patient
27 April 2021 - After weeks of controversy, Biogen has agreed to provide an experimental drug for combating ALS to ...
Posted by Michael Wonder on 28 Apr 2021
EYEMATE system for remote glaucoma management obtains FDA breakthrough device designation
28 April 2021 - - Implandata Ophthalmic Products has announced today that its game-changing EYEMATE system for digitally enabled remote patient ...
Posted by Michael Wonder on 28 Apr 2021
FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for PD-L1 positive, metastatic triple negative breast cancer
27 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 7 to 2 in favour of ...