FDA Approval

Sep 17, 2024, 22:06 ET Senhwa Biosciences Announces IND Submission to US FDA for Pilot Study of Pidnarulex Pharmacodynamics in Patients with Advanced Solid Tumors sponsored by NCI

Senhwa Biosciences, Inc. (TPEx: 6492), , a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and...

Sep 17, 2024, 08:00 ET See-Mode Technologies Receives FDA Clearance for Thyroid Ultrasound AI Analysis and Reporting Software

See-Mode Technologies, a global innovator in AI for ultrasound imaging, today announced the receipt of 510(k) clearance from the U.S. Food and Drug...

Sep 17, 2024, 07:00 ET Boston Scientific Receives FDA Approval for Expanded Indication of INGEVITY™+ Pacing Leads to Include Conduction System Pacing of the Left Bundle Branch Area

Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the indication for...

Sep 16, 2024, 17:04 ET Piccolo Medical, Inc. Receives FDA Clearance for ECGuide™ Catheter Guidance Technology

Piccolo Medical, Inc. (Piccolo) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its...

Sep 16, 2024, 11:06 ET Epitomee Medical Announces FDA Clearance of its Capsule, Weight Management Device

Epitomee Medical Ltd. (TASE: EPIT), announced that the United States Food and Drug Administration (FDA) has officially cleared the Epitomee® Capsule, ...

Sep 16, 2024, 11:01 ET Epitomee Medical Announces FDA Clearance of its Capsule, Weight Management Device

Epitomee Medical Ltd. (TASE: EPIT), announced that the United States Food and Drug Administration (FDA) has officially cleared the Epitomee® Capsule, ...

Sep 16, 2024, 09:00 ET Somite Therapeutics Announces FDA Orphan Drug and Rare Pediatric Disease Designations for SMT-M01 in Duchenne Muscular Dystrophy

Somite Therapeutics, a fully integrated TechBio company leveraging big data and AI to introduce novel cell replacement therapies, today announced...

Sep 16, 2024, 08:32 ET Velsera Technology Paves the Way for Advanced Cancer Diagnostics with FDA Approval of Illumina TruSight™ Oncology Comprehensive IVD

Velsera, a leading global healthcare technology company, is excited to announce that our advanced tumor profiling technology is a key component of...

Sep 16, 2024, 08:24 ET Argon Medical Launches CLEANER Vac™ Thrombectomy System to Remove Blood Clot in the Peripheral Venous Vasculature

Argon Medical Devices, a leading provider of medical device solutions for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and...

Sep 16, 2024, 06:45 ET Designación de terapia innovadora para los comprimidos sublinguales de Sanbexin

Sep 15, 2024, 20:32 ET Erteilung des Status eines Therapiedurchbruchs für Sanbexin-Sublingualtabletten durch die US-amerikanische Food and Drug Administration

Sep 15, 2024, 20:26 ET L'Agence américaine des produits alimentaires et médicamenteux (FDA) accorde la désignation de thérapie Breakthrough aux comprimés sublinguaux de sanbexine

Sep 14, 2024, 10:27 ET Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United States Food and Drug Administration

On September 2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin Sublingual Tablets (Edaravone and Dexborneol sublingual...

Sep 14, 2024, 07:43 ET Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United States Food and Drug Administration

On September 2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin Sublingual Tablets (Edaravone and Dexborneol sublingual...

Sep 13, 2024, 16:07 ET FDA Approves Lilly's EBGLYSS™ (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis

Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) approved EBGLYSS™ (lebrikizumab-lbkz), a targeted IL-13 ...

Sep 13, 2024, 13:30 ET Halozyme Announces FDA Approval of Roche's Subcutaneous OCREVUS ZUNOVO™ with ENHANZE® for People with Relapsing and Primary Progressive Multiple Sclerosis

Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Roche received U.S. Food and Drug Administration (FDA) approval for...

Sep 13, 2024, 01:49 ET US FDA Grants RPD Designation to Senhwa Biosciences Silmitasertib for Pediatric Neuroblastoma

Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and...

Sep 12, 2024, 20:00 ET Halozyme Announces FDA Approval of Roche's Tecentriq Hybreza™ With ENHANZE® for Multiple Types of Cancer

Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received U.S. Food and Drug Administration (FDA) approval for...

Sep 12, 2024, 08:00 ET The Kineticos AMR Accelerator Fund I Invests in Orthobond

Kineticos Life Sciences, a life sciences investor focused on companies striving to disrupt how drugs are developed, diseases are diagnosed, and...

Sep 11, 2024, 18:22 ET TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson's leadership in inflammatory bowel disease

Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for the treatment...

Sep 10, 2024, 14:00 ET Tyber Medical's PEEK ToeGrip Hammer Toe Implant Family Receives MDR Certification

Tyber Medical LLC, a leading orthopedic device manufacturer specializing in private label implants for the extremity, trauma, and spine markets, is...

Sep 10, 2024, 11:00 ET FDA Grants Rare Pediatric Disease Designation to NS-050/NCNP-03 for the Treatment of Duchenne Muscular Dystrophy

NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced that the Food and Drug Administration (FDA) has...

Sep 10, 2024, 08:53 ET Aquila Solutions Launches Altair

Aquila Solutions, a leader in regulatory and pharmaceutical management consulting, proudly announces the launch of Altair. Altair is a cutting-edge...