Blog
RSS FeedPosted by Michael Wonder on 27 Apr 2025
Recommendations made by the PBAC – March 2025
24 April 2025 - Recommendations made by the PBAC in March 2025 relating to the listing of medicines on the PBS ...
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 27 Apr 2025
AbbVie submits biologics license application to US FDA for trenibotulinumtoxinE (TrenibotE) for the treatment of glabellar lines
24 April 2025 - Submission is supported by data from over 2,100 patients treated with TrenibotE throughout the clinical program. ...
Posted by Michael Wonder on 27 Apr 2025
Acoramidis approved to treat wild-type or variant transthyretin amyloidosis in adults with cardiomyopathy
25 April 2025 - The MHRA has approved the medicine acoramidis (Beyonttra) to treat adult patients with cardiomyopathy caused by ...
Posted by Michael Wonder on 27 Apr 2025
Tremfya (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease
25 April 2025 - Johnson & Johnson today announced that the European Commission has approved a Marketing Authorisation for Tremfya (guselkumab) ...
Posted by Michael Wonder on 26 Apr 2025
CHMP recommends approval of Oczyesa for treatment of acromegaly in the EU
25 April 2025 - Camurus today announced that the EMA's CHMP has adopted a positive opinion for market authorisation of Oczyesa, ...
Posted by Michael Wonder on 25 Apr 2025
Multiple myeloma drug subsidised after treatment costs ballooned
24 April 2025 - It’s one of the few cancers still considered incurable, and those diagnosed with multiple myeloma will likely ...
Posted by Michael Wonder on 25 Apr 2025
FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma
23 April 2025 - Today, the FDA approved penpulimab-kcqx (Akeso Biopharma) with cisplatin or carboplatin and gemcitabine for the first-line ...
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 23 Apr 2025
Health Canada approves Keytruda plus pemetrexed and platinum chemotherapy as first-line treatment for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma
22 April 2025 - Approval is based on the results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial. ...
Posted by Michael Wonder on 22 Apr 2025
EMA publishes agenda for 22-25 April 2025 CHMP meeting
22 April 2025 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 18 Apr 2025
Regeneron provides update on Eylea HD (aflibercept) injection 8 mg supplemental biologics license application
18 April 2025 - Regeneron Pharmaceuticalstoday announced that the US FDA has issued a complete response letter regarding the supplemental biologics ...
Posted by Michael Wonder on 18 Apr 2025
Dupixent (dupilumab) approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria
18 April 2025 - Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo. ...
Posted by Michael Wonder on 18 Apr 2025
Health Canada expands Jemperli (dostarlimab for injection) plus chemotherapy approval to all adult patients with primary advanced or first recurrent endometrial cancer, as the first and only immuno-oncology-based treatment to show an overall survival benefit for these patients
17 April 2025 - Approval based on RUBY Part 1 trial, where Jemperli plus chemotherapy demonstrated a statistically significant and ...