Blog
RSS FeedPosted by Michael Wonder on 22 May 2026
FDA approves new Guardant360 Liquid CDx, the largest FDA approved liquid biopsy panel with a 100x expanded footprint
20 May 2026 - Guardant Health today announced that the US FDA has approved Guardant360 Liquid CDx, advancing blood-based comprehensive genomic ...
Posted by Michael Wonder on 19 May 2026
FDA approves Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi), first biosimilars to Simponi (golimumab) and Simponi Aria (golimumab)
18 May 2026 - Accord BioPharma announced today that the US FDA has approved Immgolis (golimumab-sldi), a biosimilar to Simponi ...
Posted by Michael Wonder on 18 May 2026
Baxfendy approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension
18 May 2026 - Approval based on BaxHTN Phase 3 results showing statistically significant and clinically meaningful reduction in systolic blood ...
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 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 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
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 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 ...
Posted by Michael Wonder on 03 May 2026
Incyte announces FDA Approval of Jakafi XR (ruxolitinib) extended release tablets for the treatment of myelofibrosis, polycythemia vera and graft versus host disease
1 May 2026 - Jakafi XR will be available for pharmacy orders by 8 May 2026. ...
Posted by Michael Wonder on 02 May 2026
Stelara paediatric Crohn’s disease FDA approval J&J statement
1 May 2026 - On 15 April 2026, the US FDA approved Stelara (ustekinumab) for the treatment of patients two ...
Posted by Michael Wonder on 01 May 2026
FDA approves vepdegestrant for ER positive, HER2 negative, ESR1 mutated advanced or metastatic breast cancer
1 May 2026 - Today, the FDA approved vepdegestrant (Veppanu, Arvinas), a heterobifunctional protein degrader, for adults with oestrogen receptor ...
Posted by Michael Wonder on 01 May 2026
FDA approves first non-antipsychotic drug to treat agitation associated with dementia
30 April 2026 - The US FDA today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets ...
Posted by Michael Wonder on 28 Apr 2026
FDA approves Caplyta (lumateperone) sNDA with robust new data supporting reduced risk of relapse in schizophrenia
27 April 2026 - Johnson & Johnson announced today that the US FDA has approved a supplemental new ddrug application based ...