U.S. Food and Drug Administration– tag –
-
Daiichi Sankyo/AstraZeneca’s Datroway Receives US FDA Approval for First-Line Metastatic TNBC, EMA CHMP Gives Positive Opinion
Chemistry Today USA Overview Datroway (datopotamab deruxtecan), the TROP2-directed DXd ADC co-developed by Daiichi Sankyo and AstraZeneca, has received US FDA approval as a first-line treatment for unresectable or metastatic triple-negat... -
FDA Grants Breakthrough Therapy Designation to JBS-003 (18F-FMISO), First PET Tracer to Guide Radiation De-escalation in HPV-Positive Oropharyngeal Cancer
Cancer Network USA Overview The U.S. FDA has granted Breakthrough Therapy Designation to JBS-003 (18F-fluoromisonidazole [FMISO]), the first hypoxic PET tracer intended to identify tumor hypoxia and guide radiation therapy de-escalation ... -
Ultragenyx Announces Promising Phase 3 ASPIRE Results for Apazunersen (GTX-102), an ASO Therapeutic for Angelman Syndrome
Ultragenyx Pharmaceutical Inc. USA Overview Ultragenyx has reported promising results from its Phase 3 ASPIRE trial of Apazunersen (GTX-102), an ASO therapeutic for Angelman Syndrome. This drug, one of the first investigational agents ta... -
Bepirovirsen Achieves 20% Functional Cure Rate in Chronic Hepatitis B, Approved in Japan, Filed in China, FDA PDUFA October 2026
OligoTherapeutics.org Japan Overview The antisense oligonucleotide (ASO) bepirovirsen has achieved a 20% functional cure rate in Phase III trials for chronic hepatitis B (CHB) patients, significantly surpassing the 1-3% rate seen with st... -
Ionis ASO Therapy Zanvastro Receives First-Ever FDA Approval for Alexander Disease, Demonstrates Significant Stabilization of Walking Speed
Ionis Pharmaceuticals USA Overview Ionis Pharmaceuticals' antisense oligonucleotide (ASO) therapeutic, Zanvastro (zilganersen), has secured FDA approval as the first treatment for Alexander disease (AxD), a rare and progressive neurodege... -
FDA Grants Fast Track Designation to Four Novel Cancer Therapeutics, Accelerating Development for Urgent Needs
Targeted Oncology USA Overview In August 2026, the U.S. FDA granted Fast Track designation to four novel oncology drugs, significantly accelerating their development and review processes. These include Erasca Inc.'s ERAS-0015 (pancreatic... -
FDA Approves Lisraya (Brepocitinib) as First Oral JAK Inhibitor for Adult Dermatomyositis, Efficacy & Safety Confirmed in Phase 3 Trial of 241 Patients
FDA USA Overview The US FDA has approved Lisraya (brepocitinib) tablets as the first oral treatment for adult dermatomyositis. Granted Orphan Drug and Priority Review designations, this JAK pathway inhibitor effectively reduces inflammat... -
Pin Therapeutics Unveils Oral CK1α Molecular Glue Degrader PIN-5018 for Adenoid Cystic Carcinoma at China TPD Forum, Phase 1 Underway Targeting FDA Accelerated Approval
Korea Biomedical Review South Korea Overview Pin Therapeutics presented PIN-5018, an oral CK1α-selective molecular glue degrader for adenoid cystic carcinoma (ACC), derived from its proprietary PinMARS platform, at the China Targeted Pro... -
Nanotechnology Overcomes Drug Delivery Challenges: Liposomes & Polymeric Nanoparticles Enhance Drug Solubility and Targeted Delivery
Scientific Review Unknown Overview A recent review highlights nanotechnology's transformative role in overcoming traditional drug delivery challenges, such as poor solubility and non-specific distribution. Diverse nanocarriers, including... -
U.S. FDA Approves Revolution Medicines’ RASONQUE™ (daraxonrasib) as First Broad RAS-Targeted Medicine for Metastatic Pancreatic Cancer
MarketScreener USA Overview Revolution Medicines announced that its RASONQUE™ (daraxonrasib), the first broad RAS-targeted medicine for metastatic pancreatic cancer, has received U.S. FDA approval. RASONQUE had previously been granted Br...
