News by subject: FDA

Ascletis Pharma Inc. (HKEX: 1672) today announces the dosing of the first cohort of healthy subjects in the ASC42 bridging study in China for CHB indication. ASC42 is an in-house developed, novel...

Halozyme Therapeutics, Inc. today announced that Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the...

UVision360, Inc., an innovative medical device company, announces today that the U.S. Food and Drug Administration (FDA) has approved the Company's expanded reprocessing procedures for use with the LUMINELLE DTx System. This expansion will allow the...

Kintor Pharmaceutical Limited (HKEX:9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has greenlighted pyrilutamide's phase...

- Ortho's new VITROS® Anti-SARS-CoV-2 IgG Quantitative Test targets the S1 spike protein and is calibrated to the WHO International Standard for anti-SARS-CoV-2 IgG antibodies, which gives clinicians and public health leaders a standard tool to...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. today announced the U.S. Food and Drug Administration (FDA) granted PADCEV® (enfortumab vedotin-ejfv) regular approval in the U.S., in addition to...

Breckenridge Pharmaceutical, Inc. announced today that it has launched Zolpidem Tartrate Extended-Release Tablets, USP (generic for Ambien® CR), manufactured by Centaur Pharmaceuticals Pvt. Ltd.  Breckenridge will market the product in its own label...

AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced it received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for healthcare professionals to use the KardiaMobile 6L...

TriAct Therapeutics, a private, late clinical stage oncology therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead drug, iniparib, for the treatment of patients...

Hyalex Orthopaedics, Inc., announced that the HYALEX® Cartilage System has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The HYALEX Cartilage System is intended to repair cartilage defects and restore...

Bold Therapeutics, a clinical-stage biopharmaceutical company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug Application (IND) amendment for BOLD-100-001, allowing for the addition of...

UVision360, Inc., an innovative medical device company, announces today that the U.S. Food and Drug Administration (FDA) has approved the patented LUMINELLE 360° Bx (Biopsy) Sheath which expands the capability of the LUMINELLE® DTx System.  The...

Eucure Biopharma, a wholly owned subsidiary of Biocytogen dedicated to developing antibody drugs with independent intellectual property rights, announced that the U.S. Food and Drug Administration (FDA) has approved two phase II clinical trials for...

Sirnaomics, Inc., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today that the company's IND application for a systemic siRNA (small interfering RNA) drug candidate, STP707, received the U.S. Food...

CytoSorbents Corporation announces the full approval of its Investigational Device Exemption (IDE) application to conduct the pivotal STAR-T (Safe and Timely Antithrombotic Removal ? Ticagrelor) double-blind, randomized, controlled trial (RCT) in...

Inbiose, a leading biotech company active in the development of Human Milk Oligosaccharides (HMOs), is pleased to announce that it has submitted its application for a Generally Recognized as Safe (GRAS) approval by the US Food & Drug Administration...

BioGX, a global provider of...

Anchora Medical, an Israel-based medical device company, announced today that it has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) to market its Su2ura® Approximation Device, an innovative, automated...

BioGX, a global provider of molecular diagnostic solutions, announced that the United States Food and Drug Administration has issued Emergency Use Authorization (EUA) for their breakthrough direct sample addition, Xfreetm COVID-19 test. Xfree...

Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) to...

Immunic, Inc. , a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of its...

Jazz Pharmaceuticals plc today announced the U.S. Food and Drug Administration (FDA) approval of Rylazetm (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of...

Today, the U.S. Food and Drug Administration approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric...

Abbott today announced its XIENCE family of stents has received U.S. Food and Drug Administration (FDA) approval for one-month (as short as 28 days) DAPT labeling for high bleeding risk (HBR) patients in the U.S. In addition, XIENCE stents recently...

Vivera Pharmaceuticals, Inc. and diagnostic testing distributor, Areum Bio LLC, today announce their channel partnership to expand the distribution of Access Bio, Inc.'s CareStarttm COVID-19 Rapid Antigen Test and line of products granted FDA...

Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that the U.S. Food and Drug Administration (FDA) has approved the application for a Phase I/II trial under an Investigational New...

Interventional Systems announced MicromateTM, the world's smallest robot for percutaneous procedures, received its FDA 510(k) clearance, allowing the robotics company to operate in the USA....

CNS Pharmaceuticals, Inc.  ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that the U.S. Food and...

Neuros Medical, Inc., announced today that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel High-Frequency Nerve Block system as an aid in the management of chronic intractable...

Galderma announced today the U.S. Food and Drug Administration (FDA) has approved Restylane® Contour for cheek augmentation and correction of midface contour deficiencies in adults over the age of 21.1 Restylane Contour, a new hyaluronic acid (HA)...

VICO Therapeutics, a Leiden, the Netherlands, based biotech company focusing on the development of RNA modulating therapies for rare neurological disorders, today announced that the Office of Orphan Products Development (OOPD) of the U.S. Food and...

Angel Medical Systems, Inc., (dba AngelMed) a proactive diagnostics company focused on the advancement of long-term management of high-risk coronary disease, announced today the FDA approval of the second-generation AngelMed Guardian® device. The...

Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") , a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track...

InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib for...

Camurus announced today that the New Drug Application (NDA) by Camurus' US licensee Braeburn for Brixaditm (buprenorphine) extended-release weekly and monthly injection for subcutaneous use for moderate to severe opioid use disorder was accepted for...

Braeburn announces that the New Drug Application (NDA) for BRIXADI (buprenorphine) extended-release weekly and monthly injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use disorder was accepted by the U.S. Food and Drug...

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic...

BioArctic AB's (publ) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?) protofibril antibody for the...

Resolve Therapeutics, pioneering first-in-class, targeted, safe therapies for underserved autoimmune diseases, today announced that the US Food and Drug Administration has approved a New Investigational Drug application for RSLV-132 to initiate a...

EndyMed Medical Ltd., a pioneer and world leader in the use of multi-source radiofrequency for professional aesthetic treatments, is proud to announce that it received over the counter home use FDA clearance for the NEWA, its energy based skin care...

Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for treatment of retinal degenerative diseases, today announced that its Investigational New Drug application (IND) is now open for Phase 2b clinical trial...

Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (hereafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL from the...

Onkos Surgical, a leading innovator of solutions for musculoskeletal oncology and complex orthopaedic procedures, today announced that it has received FDA 510(k) clearance for its modular collar portfolio featuring the Company's BioGrip® 3D-printed...

Targovax ASA (OSE: TRVX), a clinical stage immune-oncology company developing immune activators to target hard-to-treat solid tumors, today announces that its lead clinical candidate ONCOS-102 has received Fast Track designation in PD-1-refractory...

Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they...

Sarfez Pharmaceuticals announced today approval by the U.S. Food and Drug Administration (FDA) of the Virginia-based company's New Drug Application for Soaanz®, a once-a-day improved formulation of the loop diuretic torsemide. The approved drug...

Medtronic plc , the global leader in medical technology, today announced it received U.S. Food and Drug Administration (FDA) expanded approval for the Arctic Fronttm Family of Cardiac Cryoablation Catheters for the treatment of recurrent...

As summer travel ramps up and employees return to work, COVID-19 testing and reporting just got easier with GetMyDNA's DTC test kit, which is now available not only online, but also for bulk orders and retail purchase. GetMyDNA's easy to read report...

Spinologics Inc. /  Spino Modulation Inc., a subsidiary of Spinologics Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its MIScolitm system, an innovative vertebral...