Nuance Pharma Announces IND Clearance for Actair® Pivotal Clinical Trial in China
NMPA Approval Marks Key Milestone in Advancing House Dust Mite Allergy Immunotherapy to Chinese Patients SHANGHAI, May 22, 2026 /PRNewswire/ -- Nuance Pharma today announced that the National Medical Products Administration (NMPA) has cleared its...
3Shape Receives FDA 510(k) Clearance for 3Shape Dx Software
COPENHAGEN, Denmark, April 28, 2026 /PRNewswire/ -- 3Shape today announced that the U.S. Food and Drug Administration (FDA) has granted FDA clearance for its Dx Software following a review completed on April 10. 2026. The 510(k) Premarket...
DCwire® Micro Guidewire Receives FDA 510(k) Clearance, Marking a Key Milestone in Peijia Medical's Global Expansion
SUZHOU, China, March 18, 2026 /PRNewswire/ -- Peijia Medical (9996.HK), a leading Chinese domestic company in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, announced that its DCwire® Micro Guidewire has...
XellSmart Receives Fourth Consecutive US FDA & China NMPA IND Clearance for MSA-P iPSC-derived Cell Therapy
SUZHOU, China, March 2, 2026 /PRNewswire/ -- In February 2026, XellSmart Pharmaceutical Co., Ltd. (XellSmart) announced that it had secured its fourth US FDA and China NMPA clearance for Phase I/II registrational clinical trial entry with its...
FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIX®, Expanding Clinical Microbiology Capabilities
MURRIETA, Calif., Feb. 17, 2026 /PRNewswire/ -- Copan Group announced today that PhenoMATRIX®, its automated image assessment software used with WASPLab® full laboratory automation, received FDA 510(k) clearance as a Class II device in the United...
CStone Announces FDA Clearance of IND Application for Its Novel Trispecific Antibody CS2009 (PD-1/VEGF/CTLA-4) to Advance into Phase II Clinical Trial
CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical trial in patients with advanced solid tumors. This marks a...
MicuRx Announces FDA Clearance of IND Application to Proceed to Phase 2a Trial of MRX-5 in Patients with Mycobacterium abscessus Pulmonary Disease
FOSTER CITY, Calif., Jan. 29, 2026 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc. ("MicuRx"), a clinical-stage biopharmaceutical company focused on developing novel anti-infective therapies for drug-resistant bacterial infections, recently announced...
Terumo Interventional Systems Announces Its New OPUSWAVE® Dual Sensor Imaging System and DualView® Imaging Catheter Receive FDA 510(k) Clearance
OPUSWAVE Imaging System combines OFDI and IVUS into a single catheter, providing significant potential to reduce procedural time and costs in treating coronary artery disease DualView imaging catheter offers a 150mm maximum pullback length, a 2.6...
Nuevocor Announces FDA Clearance of IND for NVC-001 for LMNA-Related Dilated Cardiomyopathy
LMNA-related dilated cardiomyopathy (LMNA DCM) is one of the most aggressive forms of DCM, affecting approximately 100,000 individuals in the United States and Europe, who progress rapidly to end-stage heart failure. NVC-001 demonstrated significant...
YolTech Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for YOLT-101, an In Vivo Base Editing Therapy to Treat Heterozygous Familial Hypercholesterolemia (HeFH)
SHANGHAI, June 6, 2025 /PRNewswire/ -- YolTech Therapeutics, a clinical-stage biotechnology company developing in vivo genome editing therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's...