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RSS FeedPosted by Michael Wonder on 19 May 2026
Bayer granted priority review by US FDA for asundexian in patients after a non-cardioembolic ischaemic stroke or transient ischaemic attack
19 May 2026 - Bayer today announced that the US FDA has accepted the company’s new drug application and granted priority ...
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
US FDA grants priority review to supplemental new drug application for Hyrnuo (sevabertinib) under investigation as a first-line treatment of HER2 mutated non-small cell lung cancer
18 May 2026 - Regulatory submission for first-line use of Hyrnuo is based on results from the on-going Phase I/II SOHO-01 ...
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 17 May 2026
MHRA approves beremagene geperpavec (Vyjuvek) for the treatment of dystrophic epidermolysis bullosa
15 May 2026 - The MHRA has today approved beremagene geperpavec (Vyjuvek) for the treatment of wounds in patients with dystrophic ...
Posted 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 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 13 May 2026
Kyverna Therapeutics announces initiation of rolling SPS BLA submission
12 May 2026 - The Company has initiated its rolling BLA submission, seeking priority review under the program's regenerative medicine advanced ...
Posted by Michael Wonder on 13 May 2026
BridgeBio submits NDA to FDA for encaleret for individuals living with ADH1
12 May 2026 - BridgeBio Pharma today announced the submission of its new drug application to the FDA for encaleret as ...
Posted by Michael Wonder on 13 May 2026
Agios submits sNDA to FDA for US accelerated approval of mitapivat in sickle cell disease
12 May 2026 - Agios Pharmaceuticals today announced the submission of its supplemental new drug application to the US FDA for ...
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 ...