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RSS FeedPosted by Michael Wonder on 05 Jan 2022
U.S. FDA approves Immix Biopharma rare paediatric disease designation for IMX-110 as a treatment for life-threatening paediatric cancer
3 January 2021 - Immix Biopharma announced today that the U.S. FDA has granted rare paediatric disease designation for IMX-110 for ...
Posted by Michael Wonder on 05 Jan 2022
Amylyx Pharmaceuticals submits marketing authorisation application for AMX0035 for the Treatment of ALS
4 January 2022 - Amylyx Pharmaceuticals today announced it has submitted a marketing authorisation application to the EMA's CHMP for ...
Posted by Michael Wonder on 05 Jan 2022
FDA grants breakthrough therapy designation for Cullinan Oncology’s CLN-081 in patients with locally advanced or metastatic EGFR mutated non-small-cell lung cancer
4 January 2022 - Cullinan Oncology today announced that the U.S. FDA has granted breakthrough therapy designation for CLN-081 for ...
Posted by Michael Wonder on 04 Jan 2022
TGA grants provisional determination to AstraZeneca for COVID-19 prophylaxis and treatment, tixagevimab and cilgavimab (Evusheld)
4 January 2022 - On 4 January 2022, the TGA granted a further provisional determination to AstraZeneca in relation to ...
Posted by Michael Wonder on 04 Jan 2022
AbbVie announces U.S. FDA granted breakthrough therapy designation to telisotuzumab vedotin for previously treated non-small-cell lung cancer
4 January 2022 - There are currently no approved cancer therapies specifically for patients with c-Met overexpressing non-small-cell lung cancer. ...
Posted by Michael Wonder on 04 Jan 2022
Zogenix submits type II variation application to the EMA to expand the use of Fintepla (fenfluramine) for the treatment of seizures associated with Lennox-Gastaut syndrome
20 December 2021 - Zogenix today announced that it has submitted its type II variation market authorisation application to the EMA ...
Posted by Michael Wonder on 04 Jan 2022
Spero Therapeutics announces FDA acceptance and priority review of new drug application for tebipenem hydrobromide for the treatment of complicated urinary tract infections including pyelonephritis
3 January 2022 - The FDA has set a Prescription Drug User Fee Act target action date of 27 June 2022. ...
Posted by Michael Wonder on 04 Jan 2022
Genprex receives U.S. FDA fast track designation for Reqorsa immunogene therapy in combination with Keytruda for the treatment of non-small-cell lung cancer
3 January 2022 - Second FDA fast track designation further validates the potential of Reqorsa. ...
Posted by Michael Wonder on 04 Jan 2022
Novavax submits final data packages to U.S. FDA as prerequisite to Emergency Use Authorisation application request for COVID-19 Vaccine
30 December 2021 - EUA application request to be submitted following one month required by FDA EUA guidance. ...
Posted by Michael Wonder on 03 Jan 2022
FDA grants ILiAD Biotechnologies fast track designation for next generation pertussis vaccine BPZE1
3 January 2021 - ILiAD Biotechnologies, today announced that the U.S. FDA has granted fast track designation to BPZE1, a next ...
Posted by Michael Wonder on 03 Jan 2022
FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 Vaccine
3 January 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 Vaccine to: ...
Posted by Michael Wonder on 01 Jan 2022
Paion submits extension application of marketing authorisation for remimazolam in the indication general anaesthesia to the European Medicines Agency
31 December 2021 - Paion today announces that it has submitted an extension application to the marketing authorisation for remimazolam ...
Posted by Michael Wonder on 01 Jan 2022
Xeris Biopharma announces U.S. FDA approval of Recorlev (levoketoconazole) for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome
30 December 2021 - FDA approval supported by positive results from the pivotal Phase 3 SONICS and LOGICS studies demonstrating Recorlev ...
Posted by Michael Wonder on 31 Dec 2021
Celltrion acquires approval for its new Humira 'Yuflyma' in Canada
30 December 2021 - Celltrion announced on December 30 that it won marketing approval from Health Canada for "Yuflyma", a ...
Posted by Michael Wonder on 31 Dec 2021
FDA accepts Arcutis Biotherapeutics’ new drug application for roflumilast cream for adults and adolescents with plaque psoriasis
22 December 2021 - FDA has set a target action date of 29 July 2022. ...