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 27 Jan 2023
Bristol Myers Squibb announces positive CHMP opinion for once daily Sotyktu (deucravacitinib) as a treatment for adults with moderate to severe plaque psoriasis
27 January 2023 - CHMP recommendation based on positive results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials and ...
Posted by Michael Wonder on 27 Jan 2023
FDA approves elacestrant for ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer
27 January 2023 - Today, the FDA approved elacestrant (Orserdu, Stemline Therapeutics) for post-menopausal women or adult men with ER ...
Posted by Michael Wonder on 27 Jan 2023
Highlights from the CHMP 23-26 January 2023 meeting
27 January 2023 - Four new medicines recommended for approval. ...
Posted by Michael Wonder on 27 Jan 2023
FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma
27 January 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for relapsed or refractory mantle ...
Posted by Michael Wonder on 27 Jan 2023
Valeo Pharma announces filing of a new drug submission with Health Canada for sabizabulin for the treatment of hospitalised COVID-19 patients
26 January 2023 - In the final analysis of the Phase 3 clinical study conducted by Veru, sabizabulin showed a 51.6% ...
Posted by Michael Wonder on 27 Jan 2023
Dupixent (dupilumab) recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis
27 January 2023 - Recommendation based on a Phase 3 trial in children 6 months to 5 years old showing Dupixent ...
Posted by Michael Wonder on 27 Jan 2023
Recommendations made by the PBAC – December 2022 intracycle meeting
27 January 2023 - Recommendations made by the PBAC in December 2022 relating to the listing of drugs on the PBS ...
Posted by Michael Wonder on 27 Jan 2023
Risankizumab for the treatment of patients with previously treated moderate to severe active Crohn's disease
27 January 2023 - The Department of Health and Social Care has asked NICE to produce guidance on using risankizumab in ...
Posted by Michael Wonder on 27 Jan 2023
MSAC publishes agenda for April 2023 PASC meeting
27 January 2023 - The MSAC Secretariat has published a list of applications scheduled to be considered by the PICO Advisory ...
Posted by Michael Wonder on 27 Jan 2023
Marketing authorisation application for lecanemab as treatment for early Alzheimer's disease accepted by EMA
27 January 2023 - Eisai and Biogen announced today that the EMA has accepted a marketing authorisation application for lecanemab, an ...
Posted by Michael Wonder on 26 Jan 2023
Syros receives fast track designation from the FDA for tamibarotene for the treatment of higher-risk myelodysplastic syndrome
26 January 2023 - Currently evaluating tamibarotene in combination with azacitidine pivotal SELECT-MDS-1 Phase 3 clinical trial in newly diagnosed higher-risk myelodysplastic ...
Posted by Michael Wonder on 26 Jan 2023
FDA approves pembrolizumab as adjuvant treatment for non-small-cell lung cancer
26 January 2023 - Today, the FDA approved pembrolizumab (Keytruda, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for ...
Posted by Michael Wonder on 26 Jan 2023
Big pharma groups rejoin battle with governments on drug prices
24 January 2023 - Tight budgets and US reforms are ending a truce between the industry and health authorities. ...
Posted by Michael Wonder on 26 Jan 2023
New atopic dermatitis drugs for young patients to get expanded coverage
26 January 2023 - As the Government moves toward expanding insurance coverage for atopic dermatitis from adult to children and ...
Posted by Michael Wonder on 26 Jan 2023
Update on US FDA emergency use authorisation of Evusheld
26 January 2023 - The US FDA has stated that AstraZeneca’s Evusheld (tixagevimab and cilgavimab) is not currently authorised for ...