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RSS FeedPosted by Michael Wonder on 21 May 2026
Bayer’s Kerendia (finerenone) granted priority review of supplemental new drug application by US FDA for treatment of adults with type 1 diabetes and chronic kidney disease
21 May 2026 - Bayer announced today that the US FDA accepted its supplemental new drug application and granted priority review ...
Posted by Michael Wonder on 20 May 2026
FDA official offers examples of RWE being used to secure drug approval
19 May 2026 - An official from the US FDA on Monday presented three case studies demonstrating how sponsors effectively ...
Posted by Michael Wonder on 20 May 2026
ImmunityBio announces FDA acceptance of supplemental BLA for Anktiva plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease
19 May 2026 - ImmunityBio today announced that the US FDA has accepted for review the supplemental biologics license application for ...
Posted by Michael Wonder on 20 May 2026
FDA accepts sNDA and grants priority review to Aqneursa for ataxia-telangiectasia
19 May 2026 - IntraBio today announced that the US FDA has accepted for review its supplemental new drug application ...
Posted by Michael Wonder on 19 May 2026
US FDA accepts Viatris new drug application for fast-acting meloxicam for the treatment of moderate to severe acute pain
18 May 2026 - Viatris today announced that the US FDA has accepted for review the new drug application for ...
Posted 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 19 May 2026
FDA grants breakthrough therapy designation to Vertanical's VER-01, a first in class non-opioid investigational treatment for chronic low back pain
18 May 2026 - Vertanical today announced that the US FDA has granted breakthrough therapy designation to VER-01, the company's ...
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 15 May 2026
Alloplex Biotherapeutics receives FDA fast track designation for Suplexa in colorectal cancer indication
13 May 2026 - Alloplex Biotherapeutics announces that the US FDA has granted fast track designation to Suplexa for the treatment ...
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
INmune Bio receives FDA fast track designation for XPro1595 in early Alzheimer's disease
14 May 2025 - INmune Bio today announced that the US FDA has granted fast track designation to XPro (pegipanermin), the ...
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 ...