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RSS FeedPosted by Michael Wonder on 15 May 2026
Sandoz confirms European Commission approval for biosimilars Bysumlog (insulin lispro) and Dazparda (insulin aspart), strengthening position in diabetes
15 May 2026 - Sandoz today confirms that the European Commission has granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda ...
Posted by Michael Wonder on 15 May 2026
FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer
15 May 2026 - Today, the FDA approved fam-trastuzumab deruxtecan-nxki (T-DXd, Enhertu, Daiichi Sankyo) for two separate indications in adults ...
Posted by Michael Wonder on 15 May 2026
FDA approves atezolizumab for adjuvant treatment of muscle invasive bladder cancer in patients with molecular residual disease
15 May 2026 - Today, the FDA approved atezolizumab (Tecentriq, Genentech) and atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) as adjuvant ...
Posted by Michael Wonder on 15 May 2026
SMC - May 2026 decisions
11 May 2026 - The Scottish Medicines Consortium, which advises on newly licensed medicines for use by NHSScotland, has today ...
Posted by Michael Wonder on 15 May 2026
Wegovy and Mounjaro for weight loss not funded
14 May 2026 - PHARMAC has assessed the application to fund Wegovy for weight loss and added it to our ...
Posted by Michael Wonder on 15 May 2026
Over 1,500 people set to benefit from first immunotherapy for aggressive stomach cancer
14 May 2026 - Over 1,500 people set to benefit from first immunotherapy for aggressive stomach cancer. ...
Posted by Michael Wonder on 13 May 2026
FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia
13 May 2026 - Today, the FDA approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology) with ...
Posted by Michael Wonder on 13 May 2026
FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
13 May 2026 - Today, the FDA granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines), a BCL-2 inhibitor, for adults ...
Posted by Michael Wonder on 13 May 2026
European Commission approves Pfizer’s Hympavzi for the treatment of adults and adolescents with haemophilia A or B with inhibitors
13 May 2026 - Pfizer today announced that the European Commission has granted marketing authorisation to expand the approved indication ...
Posted by Michael Wonder on 09 May 2026
argenx announces US FDA approval expanding Vyvgart and Vyvgart Hytrulo for use in all adult patients living with gMG
8 May 2026 - argenx today announced the US FDA approved a label expansion for Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo ...
Posted by Michael Wonder on 08 May 2026
NICE approves Duchenne muscular dystrophy treatment givinostat after commercial deal sealed
8 May 2026 - Around 530 people in England will benefit from access to the Duchenne muscular dystrophy treatment givinostat, following ...
Posted by Michael Wonder on 08 May 2026
MHRA approves donidalorsen (Dawnzera) for the treatment of hereditary angioedema
7 May 2026 - The MHRA has today approved donidalorsen (Dawnzera) for use in patients 12 years and older with hereditary angioedema to ...
Posted by Michael Wonder on 08 May 2026
FDA grants seventh approval under the National Priority Voucher Pilot Program
8 May 2026 - The US FDA today issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion ...
Posted by Michael Wonder on 08 May 2026
Bristol Myers Squibb receives European Commission approval of Sotyktu (deucravacitinib) for the treatment of active psoriatic arthritis in adults
8 May 2026 - Bristol Myers Squibb today announced that the European Commission has granted approval to Sotyktu (deucravacitinib), alone ...
Posted by Michael Wonder on 06 May 2026
Guardant Health receives FDA approval for Guardant360 CDx as a companion diagnostic for Arvinas and Pfizer’s Veppanu (vepdegestrant) for patients with ER+/HER2- advanced breast cancer with ESR1 mutations
4 May 2026 - Guardant Health today announced that the US FDA has approved the Guardant360 CDx liquid biopsy test ...