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RSS FeedPosted by Michael Wonder on 16 Oct 2021
Bristol Myers Squibb receives positive CHMP opinion for Zeposia (ozanimod) as a treatment for adult patients with moderately to severely active ulcerative colitis
15 October 2021 - CHMP recommendation based on positive results from the Phase 3 True North trial, in which Zeposia demonstrated ...
Posted by Michael Wonder on 16 Oct 2021
Janssen receives Positive CHMP opinion for Rybrevant (amivantamab) for the treatment of patients with advanced non-small cell lung cancer with EGFR exon 20 insertion mutations after failure of platinum-based therapy
15 October 2021 - If approved by the European Commission, amivantamab will be the first treatment in the European Union specifically ...
Posted by Michael Wonder on 16 Oct 2021
AbbVie receives CHMP positive opinion for risankizumab (Skyrizi) for the treatment of adults with active psoriatic arthritis in the European Union
15 October 2021 - CHMP positive opinion is based on data from two Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2. ...
Posted by Michael Wonder on 15 Oct 2021
FDA approves atezolizumab as adjuvant treatment for non-small-cell lung cancer
15 October 2021 - Today, the FDA approved atezolizumab (Tecentriq) for adjuvant treatment following resection and platinum-based chemotherapy in patients ...
Posted by Michael Wonder on 15 Oct 2021
Highlights from CHMP 11-14 October 2021 meeting
15 October 2021 - EMA’s CHMP recommended six medicines for approval at its October 2021 meeting. ...
Posted by Michael Wonder on 14 Oct 2021
COVID-19 rapid antigen self-tests approved in Australia
13 October 2021 - The TGA has approved COVID-19 self-tests (home use tests) for supply in Australia from 1 November ...
Posted by Michael Wonder on 14 Oct 2021
Rhythm Pharmaceuticals completes submission of type II variation application to the European Medicines Agency for Imcivree (setmelanotide) for Bardet-Biedl and Alström syndromes
14 October 2021 - Rhythm Pharmaceuticals today announced that it has submitted its type II variation application to the EMA for ...
Posted by Michael Wonder on 14 Oct 2021
Celltrion applies for product approval for Avastin biosimilar in EU
12 October 2021 - Celltrion said that it has completed the approval application procedure for CT-P16, a biosimilar of Avastin ...
Posted by Michael Wonder on 14 Oct 2021
Biden eyeing FDA veteran Robert Califf to lead the agency
14 October 2021 - If nominated and confirmed, Califf would take over an agency poised to make key decisions on coronavirus ...
Posted by Michael Wonder on 14 Oct 2021
FDA accepts Regen-Cov (casirivimab and imdevimab) for priority review for treatment and prophylaxis of COVID-19
14 October 2021 - European Medicines Agency also announced earlier this week it would review marketing authorisation application for the antibody ...
Posted by Michael Wonder on 14 Oct 2021
EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
14 October 2021 - EMA’s CHMP has started a rolling review of Evusheld (also known as AZD7442), a combination of ...
Posted by Michael Wonder on 14 Oct 2021
New Sarclisa (isatuximab) combination now approved by Health Canada for adults with relapsed and/or refractory multiple myeloma
13 October 2021 - The approval is based on data from the Phase 3 IKEMA trial. ...
Posted by Michael Wonder on 14 Oct 2021
Agilent receives FDA companion diagnostic approval for Ki-67 IHC MIB-1 pharmDx in high risk early breast cancer
13 October 2021 - Agilent Technologies today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as ...
Posted by Michael Wonder on 14 Oct 2021
COVID-19 vaccine weekly safety report (14 October 2021)
14 October 2021 - To 10 October 2021, approximately 31 million vaccine doses have been given in Australia – 18 million ...
Posted by Michael Wonder on 13 Oct 2021
AstraZeneca COVID-19 vaccine will no longer be made in Australia
13 October 2021 - The AstraZeneca COVID-19 vaccine will no longer be manufactured in Australia due to the demand for ...