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RSS FeedPosted by Michael Wonder on 07 Dec 2021
ICMRA high-level meeting on global health emergencies and regulatory approaches
6 December 2021 - On 1 - 2 December, International Coalition of Medicines Regulatory Authorities, a group of leading medicines regulatory ...
Posted by Michael Wonder on 07 Dec 2021
Product approval and public health at the US Food and Drug Administration
6 December 2021 - Since the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act, drug approval in ...
Posted by Michael Wonder on 06 Dec 2021
Theratechnologies submits supplemental biologics license application to FDA advancing development of IV push Trogarzo for patients living with HIV
6 December 2021 - sBLA submission with FDA follows on the back of recently announced positive TMB-302 study results. ...
Posted by Michael Wonder on 06 Dec 2021
Sapience Therapeutics receives FDA fast track designation for ST101 for the treatment of recurrent glioblastoma multiforme
6 December 2021 - Sapience Therapeutics announced today that the U.S. FDA has granted fast track designation to its lead ...
Posted by Michael Wonder on 06 Dec 2021
EMA recommends approval for use of RoActemra in adults with severe COVID-19
6 December 2021 - The EMA’s CHMP has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of ...
Posted by Michael Wonder on 06 Dec 2021
TGA provisional approval of Celltrion COVID-19 treatment regdanvimab (Regkirona)
6 December 2021 - On 6 December 2021, the TGA granted provisional approval to Celltrion Healthcare for the use of ...
Posted by Michael Wonder on 06 Dec 2021
Secura Bio announces Copiktra (duvelisib) strategic focus on T-cell lymphoma and voluntary U.S. withdrawal of the relapsed or refractory follicular lymphoma indication
3 December 2021 - Secura Bio has voluntarily withdrawn the U.S. Copiktra indication for the treatment of patients with relapsed or ...
Posted by Michael Wonder on 06 Dec 2021
Chiesi Global Rare Diseases announces updated U.S. Prescribing Information for Ferriprox (deferiprone)
3 December 2021 - Chiesi Global Rare Diseases announced today that the Ferriprox (deferiprone) Prescribing Information in the U.S. has been ...
Posted by Michael Wonder on 05 Dec 2021
RefleXion receives breakthrough device designation for lung cancer treatment
1 December 2021 - RefleXion Medical today announced that the U.S. FDA has granted the company breakthrough device designation for ...
Posted by Michael Wonder on 05 Dec 2021
FDA approves new Kyprolis (carfilzomib) combination regimen with Darzalex Faspro (daratumumab and hyaluronidase-fihj) and dexamethasone for patients with multiple myeloma at first or subsequent relapse
1 December 2021 - Kyprolis in combination with subcutaneous treatment regimen provides further options and convenience for patients with relapsed/refractory ...
Posted by Michael Wonder on 04 Dec 2021
Pfizer's COVID-19 vaccine (Comirnaty) provisionally approved for use in individuals 5 years and over
5 December 2021 - The TGA has provisionally approved the Pfizer COVID-19 vaccine, Comirnaty, for use in individuals 5 years ...
Posted by Michael Wonder on 04 Dec 2021
Janssen seeks approval of Imbruvica (ibrutinib) in a fixed duration regimen for patients with untreated chronic lymphocytic leukaemia
30 November 2021 - Application based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the safety ...
Posted by Michael Wonder on 04 Dec 2021
U.S. Food and Drug Administration accepts for priority review supplemental biologics license application for Reblozyl (luspatercept-aamt) in adults with non-transfusion dependent beta thalassaemia
3 December 2021 - Submission based on results from Phase 2 BEYOND study of Reblozyl plus best supportive care in ...
Posted by Michael Wonder on 04 Dec 2021
European Medicines Agency validates Amicus Therapeutics marketing authorisation applications for AT-GAA for the treatment of Pompe disease
3 December 2021 - Amicus Therapeutics today announced that the EMA validated the marketing authorisation applications for AT-GAA, the Company’s ...
Posted by Michael Wonder on 04 Dec 2021
Reforms needed for FDA’s regulation of medical devices
3 December 2021 - Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex ...