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RSS FeedPosted 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
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
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
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
FDA grants breakthrough therapy designation for BrainChild Bio’s B7-H3 CAR T-cell therapy for incurable paediatric brain tumours
22 April 2025 - Breakthrough therapy designation is based on the encouraging survival data from the Phase 1 BrainChild-03 trial in ...
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 ...
Posted by Michael Wonder on 17 Apr 2025
uniQure announces FDA breakthrough therapy designation granted to AMT-130 for the treatment of Huntington’s disease
17 April 2025 - Breakthrough therapy designation based on clinical evidence from Phase I/II trials showing meaningful slowing of disease progression. ...
Posted by Michael Wonder on 17 Apr 2025
Eylea HD (aflibercept) injection 8 mg sBLA accepted for FDA priority review for both the treatment of macular oedema following retinal vein occlusion and for monthly dosing in approved indications
17 April 2025 - If approved, Eylea HD would be the first and only treatment for RVO indicated for up to ...
Posted by Michael Wonder on 17 Apr 2025
Neurelis announces FDA approval for immediate use seizure medication Valtoco (diazepam nasal spray) in age 2 to 5
16 April 2025 - Valtoco maintains orphan drug exclusivity for Valtoco to treat episodes of frequent seizures. ...
Posted by Michael Wonder on 16 Apr 2025
FDA grants fast track status to Prescient’s PTX-100, advancing commercialisation pathway
16 April 2025 - Prescient Therapeutics has received fast track designation from the US FDA for its lead candidate PTX-100, ...