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January 5, 2024
There have been several changes to the pharmaceutical and biotech regulatory landscape in 2023. The short and long-term impacts of these changes are relatively unknown; however, all could shape the regulatory landscape for life sciences in 2024 and beyond.What are the regulatory changes?Reform of the European Union&...
January 3, 2024
NDA submitted to FDA and MAA validated by EMA in December 2023 Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term...
January 1, 2024
Takeda TSE4502NYSETAK today announced that the European Medicines Agencys EMA Committee for Medicinal Products for Human Use CHMP has recommended the approval under exceptional circumstances of recombinant ADAMTS13 rADAMTS13 for the treatment of ADAMTS13 deficiency in children and adult patients with cTTP.
December 28, 2023
On December 15, 2023, Vertex announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the conditional...
December 22, 2023
Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024Company reaffirms potential for European approval for...
December 22, 2023
Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024Company reaffirms potential for European approval for ONS-5010 with Marketing Authorization Application ...
December 22, 2023
By Chris Wack Cidara Therapeutics shares were up 12% to 83 cents after the company said Rezzayo, or rezafungin acetate, has been approved in the European...
December 22, 2023
Approval based on positive results from the pivotal ReSTORE Phase III clinical trial and supported by the STRIVE Phase II clinical trials and extensive nonclinical development program.REZZAYO...
December 22, 2023
The stock market has taken investors on a wild ride this year, with plenty of ups and downs along the way. Following an early 2023 surge, stocks witnessed some turbulence as concerns mounted over inflation, rising interest rates, banking turmoil, and escalating geopolitical tensions worldwide.
December 22, 2023
Mundipharma today announced rezafungin (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults. The approval by the European Commission (EC) follows the positive opinion of the Committee...