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RSS FeedPosted by Michael Wonder on 18 Mar 2025
Zorvye cream 0.15% approved by Health Canada for the treatment of mild to moderate atopic dermatitis in adults and children as young as six years of age
17 March 2025 - Once daily, steroid free topical treatment designed to rapidly reduce itch and proactively support long term disease ...
Posted by Michael Wonder on 18 Mar 2025
Skyclarys (omaveloxolone) approval by Health Canada ushers in a new era for Friedreich's ataxia treatment in Canada
17 March 2025 - As the only approved treatment to address disease progression, Skyclarys addresses a long standing gap in the ...
Posted by Michael Wonder on 12 Mar 2025
Sydnexis announces FDA acceptance of new drug application and PDUFA date for SYD-101 for the treatment of progression of paediatric myopia
11 March 2025 - Sydnexis today announced that the US FDA has accepted its new drug application for SYD-101 and ...
Posted by Michael Wonder on 11 Mar 2025
Health Canada authorises Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer
10 March 2025 - Phase 3 MARIPOSA study showed Lazcluze plus Rybrevant significantly improved progression-free survival, reducing the risk of ...
Posted by Michael Wonder on 10 Mar 2025
Wainzua (eplontersen) approved in the EU for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy
10 March 2025 - Second major approval for Wainzua, which is marketed in the US as Wainua. ...
Posted by Michael Wonder on 10 Mar 2025
US FDA approves Celltrion's Omlyclo (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing Xolair
9 March 2025 - Regulatory approval for interchangeability was supported by positive Phase 3 data demonstrating comparable efficacy and safety profile ...
Posted by Michael Wonder on 08 Mar 2025
Vertex announces UK MHRA approval of Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), a once daily next in class CFTR modulator for the treatment of cystic fibrosis
7 March 2025 - In head to head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and further decreased sweat chloride ...
Posted by Michael Wonder on 08 Mar 2025
Acarizax approved in Canada for treatment of young children
7 March 2025 - ALK today announced that Health Canada has approved ALK’s Acarizax tablet for use in children, aged ...
Posted by Michael Wonder on 07 Mar 2025
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma
7 March 2025 - Approval based on results of Phase 3 CheckMate-9DW clinical trial demonstrating a statistically significant and clinically ...
Posted by Michael Wonder on 07 Mar 2025
Lazertinib approved for use in combination with amivantamab for the treatment of adults with non-small cell lung cancer
6 March 2025 - The MHRA has today approved lazertinib (Lazcluze) for adults with non-small cell lung cancer that has spread ...
Posted by Michael Wonder on 07 Mar 2025
Ferring receives Health Canada approval for Rebyota (faecal microbiota, live)
6 March 2025 - A novel first in class microbiome restoration therapy for the prevention of recurrence of C. difficile infection. ...
Posted by Michael Wonder on 05 Mar 2025
FDA accepts supplemental biologics license application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
5 March 2025 - The filing application is based on data from the Phase 3 REGENCY study, where Gazyva/Gazyvaro showed superiority ...
Posted by Michael Wonder on 05 Mar 2025
Tevimbra approved in US for first-line treatment of advanced oesophageal squamous cell carcinoma in combination with chemotherapy
4 March 2025 - New indication based on results from a global Phase 3 trial demonstrating significantly improved overall survival ...
Posted by Michael Wonder on 04 Mar 2025
Qalsody (tofersen injection) receives conditional marketing authorisation from Health Canada as the first ALS treatment targeting a genetic cause
3 March 2025 - Biogen's second rare disease therapy to be approved in Canada reflects a continued commitment to advancing ...
Posted by Michael Wonder on 03 Mar 2025
TGA decides not to register lecanemab in Australia
3 March 2025 - BioArctic's partner Eisai announced today that the TGA has declined the approval of lecanemab as a treatment ...