Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 25 Sep 2024
Santhera announces acceptance by Swissmedic of marketing authorisation application for Agamree (vamorolone) in Duchenne muscular dystrophy
24 September 2024 - Santhera Pharmaceuticals announces that Swissmedic, the Swiss Agency for Therapeutic Products, has accepted for review the ...
Posted by Michael Wonder on 25 Sep 2024
Lilly's Kisunla (donanemab-azbt) approved in Japan for the treatment of early symptomatic Alzheimer's disease
24 September 2024 - Japan is the second major market where Kisunla has received approval. ...
Posted by Michael Wonder on 25 Sep 2024
Takeda receives approval for Fruzaqla (fruquintinib) in Japan for the treatment of unresectable advanced or recurrent colorectal cancer
24 September 2024 - Approval based on results from positive, global, Phase 3 FRESCO-2 trial. ...
Posted by Michael Wonder on 25 Sep 2024
FDA accepts Arcutis’ supplemental new drug application for Zoryve (roflumilast) foam for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over
24 September 2024 - US FDA has set a PDUFA target action date of 22 May 2025. ...
Posted by Michael Wonder on 24 Sep 2024
Elevar Therapeutics resubmits new drug application to FDA for combination of camrelizumab plus rivoceranib as first-line treatment option for unresectable hepatocellular carcinoma boosted by CARES-310 leading overall survival analysis
23 September 2024 - Elevar Therapeutics today announced the resubmission of a new drug application to the US FDA for its ...
Posted by Michael Wonder on 24 Sep 2024
Improved access to medicines for urinary tract infections and Parkinson's disease
24 September 2024 - PHARMAC is widening access to a medicine to treat urinary tract infections and funding a combination ...
Posted by Michael Wonder on 24 Sep 2024
Japan's Ministry of Health, Labour and Welfare approves Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for first-line treatment of radically unresectable urothelial carcinoma
24 September 2024 - Approval based on the EV-302 trial where the treatment combination nearly doubled median overall survival and significantly ...
Posted by Michael Wonder on 24 Sep 2024
Lantern Pharma announces three US FDA rare paediatric disease designations granted to LP-184 in multiple ultra rare children’s cancers
23 September 2024 - Lantern Pharma announced today that the company has been granted three rare paediatric disease designations by the ...
Posted by Michael Wonder on 24 Sep 2024
Elevation Oncology receives fast track designation from the FDA for EO-3021 for the treatment of adult patients with advanced or metastatic gastric or gastro-oesophageal junction cancer expressing Claudin 18.2
23 September 2024 - Elevation Oncology today announced that the US FDA has granted fast track designation to EO-3021, a differentiated ...
Posted by Michael Wonder on 24 Sep 2024
Priovant Therapeutics announces receipt of fast track designation from FDA for brepocitinib in non-anterior non-infectious uveitis
23 September 2024 - First patients have been dosed in CLARITY, a Phase 3 study evaluating brepocitinib in non-anterior non-infectious uveitis. ...
Posted by Michael Wonder on 24 Sep 2024
European Commission approves Leo Pharma’s Anzupgo (delgocitinib) cream for adults with moderate to severe chronic hand eczema
23 September 2024 - Anzupgo is the first topical treatment to be specifically indicated for adult patients living with moderate to ...
Posted by Michael Wonder on 24 Sep 2024
Ipsen’s Kayfanda (odevixibat) approved in European Union for cholestatic pruritus in Alagille Syndrome, a rare liver disease
23 September 2024 - E.U. marketing authorization for Kayfanda based on data from ASSERT the only Phase 3 trial completed in ...
Posted by Michael Wonder on 24 Sep 2024
Merck receives positive EU CHMP opinions for Keytruda (pembrolizumab) regimens as treatment for patients with two types of gynaecologic cancers
20 September 2024 - Positive opinion granted for Keytruda plus chemotherapy for the first-line treatment of adult patients with primary advanced ...
Posted by Michael Wonder on 24 Sep 2024
FDA accepts Leo Pharma’s filing of delgocitinib cream new drug application for the treatment of chronic hand eczema
23 September 2024 - The application has been accepted for filing and, if approved, delgocitinib cream would become the first treatment ...
Posted by Michael Wonder on 23 Sep 2024
Out of pocket GP costs soar 45 per cent for non-bulk billed patients
22 September 2024 - Australians who don’t get a bulk billed GP appointment are paying 45% more to see a ...