Regulatory Pathway– tag –
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Prelude Therapeutics Receives IND Clearance for Oral KAT6A Degrader PRT13722 in HR+/HER2- Breast Cancer Phase 1 Study
MarketBeat USA Overview On September 10, 2026, Prelude Therapeutics announced FDA Investigational New Drug (IND) clearance for PRT13722, an oral KAT6A selective degrader. This compound is being developed for HR-positive/HER2-negative bre... -
Novel Bispecific ADC ICP-B381, Targeting PSMA and STEAP1, Approved for Phase 1 Clinical Trials in China for Prostate Cancer; US IND Submission Underway
Prostate Warriors China Overview ICP-B381, a novel bispecific antibody-drug conjugate (ADC) designed to simultaneously target PSMA and STEAP1, has received approval from Chinese regulatory authorities to commence Phase 1 clinical trials ... -
Moderna’s RSV Vaccine mRESVIA® Receives FDA Approval as mRNA Therapeutics Advance in Non-Vaccine Applications
Facebook (Vaxcyte, Vivaldi Biosciences) USA Overview Moderna's RSV vaccine mRESVIA® gained FDA approval following Breakthrough Therapy Designation, reaffirming the power of mRNA technology in infectious disease prevention. Concurrently, ... -
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... -
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 Grants Fast Track Designation to Erasca’s Oral Pan-RAS Molecular Glue ERAS-0015 for Metastatic Pancreatic Adenocarcinoma
OncLive USA Overview Erasca's oral pan-RAS molecular glue, ERAS-0015, has received FDA Fast Track Designation for metastatic pancreatic adenocarcinoma. The drug demonstrated promising initial activity in a Phase 1 study for KRAS G12-muta... -
Keymed Biosciences’ BCMA x CD3 Bispecific Antibody CM336 Advances to Phase II for Relapsed/Refractory Light Chain Amyloidosis, Secures $257M from Gilead’s Acquisition of Partner
BioSpace China Overview Keymed Biosciences announced its H1 2026 results and business updates, reporting that its BCMA x CD3 bispecific antibody, CM336, is progressing in a Phase II clinical trial for relapsed/refractory light chain amyl... -
FDA Grants Breakthrough Therapy and Fast Track Designations to Norroy Bioscience’s 68Ga-NYM096 for Clear Cell Renal Cell Carcinoma PET Imaging, First Chinese-Origin Radiopharmaceutical to Receive BTD
Targeted Oncology USA Overview The U.S. FDA has granted Breakthrough Therapy Designation (BTD) and Fast Track Designation (FTD) to Norroy Bioscience's investigational PET imaging agent, 68Ga-NYM096, for detecting clear cell renal cell ca... -
FDA Grants Dual Breakthrough and Orphan Designations to Volixibat for PSC-Related Cholestatic Pruritus
HCPLive USA Overview The U.S. FDA has granted both Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) to volixibat, an investigational ileal bile acid transporter (IBAT) inhibitor, for the treatment of cholestatic p...
