Blog
RSS FeedPosted by Michael Wonder on 28 Apr 2025
First treatment against severe thyroid eye disease
25 April 2025 - Tepezza significantly improves symptoms for patients with moderate to severe thyroid eye disease ...
Posted by Michael Wonder on 27 Apr 2025
MHRA approves first UK treatment for Friedreich’s ataxia, omaveloxolone
23 April 2025 - The MHRA) has today approved omaveloxolone (Skyclarys), the first treatment for patients aged 16 and over, in ...
Posted by Michael Wonder on 24 Apr 2025
Latest update on US FDA BLA for Novavax's COVID-19 vaccine
23 April 2025 - We believe that our biologics license application is approvable based on conversations with the US FDA, ...
Posted by Michael Wonder on 24 Apr 2025
Sarclisa approved in Canada for patients with newly diagnosed multiple myeloma
22 April 2025 - This is the third indication for Sarclisa in Canada for the treatment of multiple myeloma. ...
Posted by Michael Wonder on 23 Apr 2025
Marstacimab approved to treat patients aged 12 years and above (weighing at least 35 kg) with haemophilia A or B
22 April 2025 - The MHRA has approved the medicine marstacimab (Hympavzi) to prevent or reduce bleeding in patients 12 years ...
Posted by Michael Wonder on 10 Apr 2025
Trastuzumab deruxtecan approved to treat adults with HER2-positive cancer that has spread or cannot be removed by surgery
9 April 2025 - The MHRA has today approved trastuzumab deruxtecan (Enhertu) to treat people with solid tumours that have ...
Posted by Michael Wonder on 09 Apr 2025
FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer
8 April 2025 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb ...
Posted by Michael Wonder on 02 Apr 2025
Valneva’s chikungunya vaccine Ixchiq now authorised in EU for adolescents aged 12 and above
1 April 2025 - With this extension, Ixchiq, the first vaccine against the chikungunya virus, is now available for administration ...
Posted by Michael Wonder on 02 Apr 2025
Rystiggo now approved for adults with generalised myasthenia gravis in Canada
2 April 2025 - The approval is supported by the pivotal Phase 3 MycarinG study in gMG, which demonstrated that treatment ...
Posted by Michael Wonder on 30 Mar 2025
World first as MHRA approves trofolastat for diagnostic imaging of prostate cancer in men
28 March 2025 - The MHRA has approved trofolastat (RoTecPSMA), the first prostate-specific membrane antigen (PSMA)-targeting product authorised for use with ...
Posted 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. ...