Blog
RSS FeedPosted by Michael Wonder on 14 Mar 2022
Phathom Pharmaceuticals submits vonoprazan NDA to FDA for the treatment of erosive oesophagitis
14 March 2022 - Phathom Pharmaceuticals announced today that it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 14 Mar 2022
Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps
14 March 2022 - The US FDA has issued a complete response letter regarding the supplemental biologics license application for ...
Posted by Michael Wonder on 12 Mar 2022
Antengene announces Xpovio approved by the TGA in Australia for the treatment of relapsed and/or refractory multiple myeloma and triple class-refractory multiple myeloma
10 March 2022 - Xpovio is the first of a new class of SINE (selective inhibitor of nuclear export) medicines. ...
Posted by Michael Wonder on 12 Mar 2022
Acadia Pharmaceuticals announces 4 August 2022 action date for resubmitted supplemental new drug application for Nuplazid (pimavanserin) for the treatment of Alzheimer’s disease psychosis
9 March 2022 - The FDA plans to hold an advisory committee meeting. ...
Posted by Michael Wonder on 12 Mar 2022
Biosimilar impact on oncology clinical trial design and operations
11 March 2022 - There is a wealth of data, reviews, articles, and regulatory guidance on how to conduct clinical trials ...
Posted by Michael Wonder on 12 Mar 2022
Myriad Genetics receives FDA approval of BRACAnalysis CDx as a companion diagnostic for Lynparza in early breast cancer
11 March 2022 - BRACAnalysis CDx is now the only germline test approved by FDA as a companion diagnostic for treatment ...
Posted by Michael Wonder on 12 Mar 2022
Catalyst Pharmaceuticals and KYE Pharmaceuticals announce a second favourable Canadian Federal Court ruling setting aside approval of Ruzurgi
11 March 2022 - Catalyst Pharmaceuticals and KYE Pharmaceuticals today announced receipt of a favourable decision from the Federal Court of ...
Posted by Michael Wonder on 11 Mar 2022
Lynparza approved in the US as adjuvant treatment for patients with germline BRCA mutated HER2 negative high risk early breast cancer
11 March 2022 - First and only approved medicine targeting BRCA mutations in early breast cancer. ...
Posted by Michael Wonder on 11 Mar 2022
ATAGI update following weekly COVID-19 meeting (9 March 2022)
11 March 2022 - ATAGI have not made any new updates since 2 March 2022. ...
Posted by Michael Wonder on 11 Mar 2022
Allogene Therapeutics receives FDA fast track designation for its first solid tumour candidate, ALLO-316 in the treatment of renal cell carcinoma
10 March 2022 - ALLO-316 is an allogeneic CAR T therapy candidate targeting CD70, which has broad potential application across a ...
Posted by Michael Wonder on 11 Mar 2022
Janssen seeks approval of a new indication for Imbruvica (ibrutinib) for use in patients with untreated mantle cell lymphoma
8 March 2022 - Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ...
Posted by Michael Wonder on 10 Mar 2022
Health Canada approves Samsung Bioepis and Biogen’s Byooviz (SB11), Lucentis biosimilar (ranibizumab)
10 March 2022 - Byooviz becomes the first Lucentis biosimilar to be approved in Canada following its approval in Europe and ...
Posted by Michael Wonder on 10 Mar 2022
Servier submits a marketing authorisation application to the EMA for Tibsovo (ivosidenib) for patients with IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma
10 March 2022 - The submission covers countries of the European Union as well as Iceland, Liechtenstein and Norway. ...
Posted by Michael Wonder on 10 Mar 2022
Revance resubmits biologics license application for daxibotulinumtoxinA for injection for glabellar lines to the FDA
8 March 2022 - Revance Therapeutics today announced it has resubmitted its biologics license application to the U.S. FDA for DaxibotulinumtoxinA ...
Posted by Michael Wonder on 10 Mar 2022
Legislation would set expiration for FDA’s accelerated approvals
9 March 2022 - New legislation, introduced by a top Democrat in the House of Representatives, would codify the U.S. ...