FDA Approval

19 Jan, 2024, 08:15 ET Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in the Treatment of Patients With Refractory Progressive Multiple Sclerosis

Kyverna Therapeutics, Inc. (Kyverna), a patient-centered clinical-stage biopharmaceutical company focused on developing cell therapies for patients...

18 Jan, 2024, 08:20 ET Hoth Therapeutics Announces it Received FDA Approval to Expand HT-001 Clinical Trial to Treat Severely Ill Patients

Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, announced today that it has received U.S. Food and Drug...

18 Jan, 2024, 07:00 ET Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This...

18 Jan, 2024, 07:00 ET Nanoscope Therapeutics Provides Regulatory Update on MCO-010 for the Treatment of Retinitis Pigmentosa

Nanoscope Therapeutics Inc., a late-stage clinical biotechnology company developing gene therapies for inherited retinal diseases and age-related...

16 Jan, 2024, 15:13 ET First U.S. Implantation of VasQ™ Since FDA De Novo was Granted

The first U.S. implantation of VasQ™ since FDA De Novo was granted was successfully performed by Dr. Ari Kramer, Director and principal surgeon of...

16 Jan, 2024, 11:00 ET Bloomlife Announces FDA Clearance of Bloomlife MFM-Pro

Bloomlife, the award winning maternal health company, has received clearance from the US Food and Drug Administration (FDA) for Bloomlife MFM-Pro,...

16 Jan, 2024, 10:00 ET Tarsier Pharma Receives FDA Agreement Under Special Protocol Assessment (SPA) for Tarsier-04 Phase 3 Trial of TRS01 Ophthalmic Solution for the Treatment of Non-infectious Uveitis including Uveitic Glaucoma

Tarsier Pharma, Ltd., a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies...

16 Jan, 2024, 09:00 ET Presage Announces FDA Study May Proceed to Evaluate Pre-GMP Drug Candidate in CIVO Phase 0 Clinical Trial

Presage Biosciences, a biotechnology company whose mission is to enable precision drug response evaluation in the human tumor microenvironment (TME), ...

16 Jan, 2024, 08:15 ET Halozyme Announces Takeda Receives FDA Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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

16 Jan, 2024, 06:48 ET NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it...

15 Jan, 2024, 00:15 ET AnX Robotica is Pleased to Announce FDA Clearance for Expanded Indications of NaviCam Small Bowel Video Capsule Endoscopy

AnX Robotica, the leader in advanced gastrointestinal visualization technologies, is thrilled to announce FDA clearance for expanded indications of...

14 Jan, 2024, 20:35 ET Darmiyan 首個用於預測阿茲海默症發展可能性的預後測試 BrainSee 獲 FDA 許可

14 Jan, 2024, 20:29 ET Darmiyan获得FDA对BrainSee的批准，这是首个能够预测阿尔茨海默病痴呆症发展可能性的预后测试

12 Jan, 2024, 15:31 ET Darmiyan recibe la aprobación de la FDA para BrainSee, la primera prueba que permite predecir la probabilidad de progresión a la demencia de Alzheimer

12 Jan, 2024, 08:08 ET Darmiyan Receives FDA Approval for BrainSee, the First Prognostic Test for Predicting Likelihood of Progression to Alzheimer's Dementia

Today marks a turning point in the battle against Alzheimer's disease as Darmiyan, Inc., a leading company in brain health innovation announces the...

12 Jan, 2024, 05:13 ET RemeGen's RC88 Obtained FDA Fast Track Designation, Heralds New Hope for Ovarian Cancer Patients

RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, announced recently that its...

11 Jan, 2024, 10:25 ET Endovascular Engineering's Hēlo™ Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism

Endovascular Engineering ("E2"), a medical device company focused on the development and deployment of groundbreaking clot removal technologies that...

11 Jan, 2024, 07:00 ET U.S. FDA Approves the VISUMAX 800 with SMILE pro software from ZEISS

Carl Zeiss Meditec AG -- ZEISS Medical Technology announced today that the U.S. Food and Drug Administration (FDA) has approved the VISUMAX® 800 with ...

11 Jan, 2024, 06:00 ET Neuralace Medical Announces FDA Clearance of Axon Therapy for Chronic Painful Diabetic Neuropathy

Neuralace Medical, Inc., an innovator in pain management technology, today proudly announces the FDA clearance of its groundbreaking product, Axon...

11 Jan, 2024, 06:00 ET Zeta Surgical's Mixed Reality Navigation System Receives FDA Special 510(k) Clearance for Expanded Functionality

Zeta Surgical, a surgical robotics and mixed reality company, announced today that its Zeta Cranial Navigation System has received Special 510(k)...

10 Jan, 2024, 10:00 ET WhisperSom™ Announces Common Stock Offering

WhisperSom™ Corporation, a medical device and informatics company specializing in the diagnosis and treatment of sleep apnea and snoring, today...