U.S. Food and Drug Administration– tag –
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Biotech CEOs Anticipate Funding Rebound by Late 2026, Pin Hopes on FDA for Streamlined Drug Development
Endpoints News USA Overview A recent Endpoints 100 survey reveals 62% of biotech CEOs anticipate a significant improvement in the funding environment by late 2026, driven by a recovering IPO market and increased M&A activity. These l... -
MAIA Biotechnology Completes Global Enrollment for Phase 2 Ateganosine Trial in Refractory NSCLC
GlobeNewswire USA Overview MAIA Biotechnology has completed global enrollment for Part C of its Phase 2 THIO-101 expanded trial, evaluating ateganosine for third-line advanced non-small cell lung cancer (NSCLC). Ateganosine, an investiga... -
FDA Greenlights 24 Drugs in May 2026, Featuring AbbVie’s Decnupaz ADC and Shionogi’s Xocova COVID-19 Oral
BioWorld USA Overview The U.S. FDA approved 24 drugs in May 2026, marking the highest number of approvals in a single month this year, with eight being novel molecular entities (NMEs). This surge includes AbbVie's CD123-targeting antibod... -
FDA Greenlights Breakthrough TNBC Therapies, First-in-Class Hypertriglyceridemia Drug, and New Breast Cancer Maintenance Regimen
FDA USA Overview On June 24, 2026, the U.S. FDA announced pivotal approvals across several cancer and metabolic disease indications, introducing significant new therapeutic options. These include a breakthrough for triple-negative breast... -
FDA Grants Accelerated Approval to AVLAYAH, a BBB-Penetrating Biologic, Ushering in a New Era for Brain Drug Delivery
Drug Delivery Leader USA Overview On March 25, 2026, the FDA granted accelerated approval to AVLAYAH (tividenofusp alfa-eknm), the first biologic engineered to traverse the blood-brain barrier (BBB). This landmark decision, following dec... -
Mabwell’s World-First LILRB4/CD3 Bispecific Antibody 6MW5311 Receives FDA Clinical Trial Clearance for Hematologic Malignancies
Mabwell (press release) China Overview Mabwell has secured FDA Clinical Trial Application (CTA) clearance for 6MW5311, a LILRB4/CD3-targeting T-cell engager (TCE) bispecific antibody, for hematologic malignancies including AML, CMML, and... -
Solu Therapeutics’ STX-0712 with CyTAC™ Technology Granted FDA Fast Track for Relapsed or Refractory CMML
Pharma News (citing Solu Therapeutics) USA Overview Solu Therapeutics announced that STX-0712, utilizing its CyTAC™ technology, received FDA Fast Track designation for relapsed or refractory chronic myelomonocytic leukemia (CMML). STX-07... -
NovaBridge Biosciences’ Givastomig Secures FDA Fast Track for HER2-Negative Metastatic Gastric Cancer
Cancer Network (citing NovaBridge Biosciences) USA Overview NovaBridge Biosciences' CLDN18.2 x 4-1BB bispecific antibody, givastomig, has received FDA Fast Track designation for HER2-negative metastatic gastric cancer. This designation i... -
Biogen’s Salanersen Granted FDA Breakthrough Therapy Designation for SMA Patients with Suboptimal Gene Therapy Response
Cure SMA USA Overview Biogen's investigational spinal muscular atrophy (SMA) therapy, salanersen, has received Breakthrough Therapy Designation from the FDA. This designation is based on promising Phase 1b data in pediatric SMA patients ... -
Halia Therapeutics’ Ofirnoflast (HT-6184) Receives FDA Fast Track Designation for Lower-Risk MDS
BioUtah USA Overview Halia Therapeutics' Ofirnoflast (HT-6184), an oral NEK7 allosteric modulator for lower-risk myelodysplastic syndromes (LR-MDS), has been granted FDA Fast Track designation. This decision follows promising Phase 2 dat...
