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RSS FeedPosted 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 ...
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
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 12 May 2026
Coya Therapeutics has been granted US FDA fast track designation for COYA 302 for the treatment of amyotrophic lateral sclerosis
12 May 2026 - Coya Therapeutics today announced that the US FDA has granted fast track designation for COYA 302, ...
Posted by Michael Wonder on 12 May 2026
Emiltatug ledadotin granted breakthrough therapy designation by the US FDA for adenoid cystic carcinoma
12 May 2026 - Servier today announced that the US FDA has granted breakthrough therapy designation to emiltatug ledadotin, an investigational ...
Posted by Michael Wonder on 12 May 2026
FDA advances drug repurposing to address unmet medical needs
11 May 2026 - Agency is particularly focused on new uses to treat chronic or rare diseases. ...