News by subject: FDA

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice...

Velico Medical, an organization that is pioneering lifesaving innovation in transfusion medicine, today announced that the US Food and Drug Administration (FDA) has granted approval for the company to proceed with a Phase-I (human) clinical study for...

Stealth BioTherapeutics Corp , a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced the submission of a New Drug...

InDex Pharmaceuticals Holding AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has given clearance to start the phase III clinical study CONCLUDE in the United States. The study will evaluate the efficacy and safety of the...

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in...

Shoulder Innovations Inc, a leading innovator in the development of shoulder replacement systems, announced today that they have received FDA clearance for their InSettm Reverse Shoulder Arthroplasty System....

Leading medical image AI provider Qure.ai has announced US FDA 510(k) clearance for its Brain CT quantification product qER-Quant. Clinicians in the US can now use this tool to rapidly and precisely assess the severity of injury in patients with...

TAIPEI and SAN DIEGO, Aug. 18, 2021 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced that the US Food and...

CardioNXT announced today that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for the platform technology comprised of the iMap 3D Navigation & Mapping Systemtm, Activate Softwaretm, Sensor Enabled Axis Patient...

Jardiance® (empagliflozin) 10 mg has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF),...

The US Food and Drug Administration (FDA) has approved the first-ever pharmaceutical treatment for patients with von Hippel-Lindau (VHL) disease, a genetic condition putting patients at risk of developing several cancers and other types of tumors....

Zimmer Biomet Holdings, Inc. , a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the ROSA® Hip System for robotically-assisted direct anterior total hip replacement. ROSA Hip is the fourth...

GlaxoSmithKline (GSK) plc today announced the US Food and Drug Administration (FDA) approved a new indication for JEMPERLI (dostarlimab-gxly), a programmed cell death receptor-1 (PD-1) blocking antibody, for the treatment of adult patients with...

Therapeutic Solutions International, Inc., , announced today initiation of preparation for filing an Emergency Use Authorization (EUA) to the FDA for JadiCellstm in treatment of COVID-19 associated lung injury.  The EUA is a mechanism that allows...

Thermo Fisher Scientific, the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19...

Virbac announces the breakthrough drug STELFONTA® (tigilanol tiglate injection) that has been approved by the U.S. Food and Drug Administration (FDA) as a non-surgical alternative for treating canine mast cell tumors in dogs, is now available in...

The U.S. Food and Drug Administration (FDA) has approved an expanded label for Eli Lilly and Company's rapid-acting insulin, Lyumjev® (insulin lispro-aabc injection) 100 units/mL indicated to improve glycemic control in adults with type 1 and type 2...

Occlutech Holding AG ("Occlutech"), one of the world´s leading providers of minimally invasive structural heart disease devices, announces the conditional U.S. Food and Drug Administration ("FDA") approval of its Investigational Device Exemption...

Novatek Pharmaceuticals, INC announced today that the company received FDA approval for its investigational new drug (IND) study; Phase 2 clinical trial for its oral drug, TQ Formula, against Novel Coronavirus 2019 (COVID-19) in the outpatient...

Rigel Pharmaceuticals, Inc. , today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that clinical data submitted in late-May from a 59-patient NIH/NHLBI-sponsored Phase 2 trial of fostamatinib to treat hospitalized...

"Kidney transplant patients, based on the lifetime immunosuppressive medications they must take to stay alive, remain at severe risk of catastrophic illness and death due to COVID-19. The American Association of Kidney Patients (AAKP) thanks the U.S....

The U.S. Food and Drug Administration today approved a new indication for Xywav for idiopathic hypersomnia (IH) in adults. IH is an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night's...

Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults.1 The company plans to...

CytoSorbents Corporation , a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that the Company has been granted a second...

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 Difluprednate Ophthalmic Emulsion 0.05% from the United States Food...

Syntr Health Technologies, Inc., a medical device company specializing in the processing of autologous adipose tissue, also known as fat tissue, today announced clearance from the US Food & Drug Administration (FDA) for the company's patented...

Lantern Pharma , a clinical stage biopharmaceutical company using its proprietary RADR® artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, today announced that the U.S. Food...

Boston Scientific Corporation today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the EXALTtm Model B Single-Use Bronchoscope, designed for use in bedside procedures within the intensive care unit (ICU) and operating room...

Surround Medical Systems, Inc. (the "Company") announced today that the United States Food and Drug Administration (the "FDA") has granted 510(k) pre-market clearance for the Company's patented PORTRAYtm dental imaging system. The 510(k) pre-market...

The US Food and Drug Administration (FDA) has approved SpinTech, Inc.'s latest magnetic resonance imaging software device, STAGE (Strategically Acquired Gradient Echo), a post-processing software platform that enables comprehensive, quantitative...

Genesis Innovation Group's cultivate(MD) Capital Fund II LP, a fund focused on investments into early-stage healthcare companies with innovative technologies, announced today that one of their portfolio companies, SpinTech, has received FDA 510(k)...

Calliditas Therapeutics AB ("Calliditas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for its lead NOX inhibitor candidate setanaxib for the treatment of patients with the chronic orphan...

ImmVira announces MVR-C5252 targeting Glioblastoma has received the U.S. FDA clearance to proceed with clinical trial on August 6, 2021....

The Muscular Dystrophy Association (MDA) today celebrates the decision by the US Food and Drug Administration (FDA) to grant accelerated marketing approval to avalglucosidase alfa (Nexviazyme) for the treatment of people 1 year of age and older...

Today, the U.S. Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset Pompe disease. Patients with Pompe disease have an enzyme deficiency that...

Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Apixaban Tablets (generic for Eliquis®). This product was developed by Towa...

Therapeutic Solutions International, Inc., , announced today clearance from the Food and Drug Administration (FDA) to initiate a Phase III pivotal trial for registration of the Company's JadiCelltm universal donor stem cell as a treatment for...

Eiger BioPharmaceuticals, Inc. , a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration...

CSL Behring, a global biotherapeutics leader received U.S. Food and Drug Administration (FDA) approval for its supplemental request (submitted Aug. 30, 2020) for co-packaging of a convenience administration kit along with its product BERINERT,...

Abbott today announced it has received U.S. Food and Drug Administration (FDA) clearance for its latest optical coherence tomography (OCT) imaging platform powered by the company's new Ultreon Software. This innovative imaging software combines OCT...

On August 2, 2021, the US Food and Drug Administration approved the drug anifrolumab (Saphnelo) for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. Much of the groundwork...

The U.S. Food and Drug Administration (FDA) has approved Saphnelotm (anifrolumab-fnia) as a treatment for adults with systemic lupus erythematosus (SLE) who are receiving standard therapy. It is the third U.S. FDA approval of a lupus therapy since...

Abbott announced today that the U.S. Food and Drug Administration (FDA) has cleared the FreeStyle® Libre 2 iOS application for use with compatible iPhones1, providing a comprehensive digital offering for its FreeStyle Libre 2 integrated continuous...

RealView Imaging Ltd. today announced that it has received FDA 510(k) clearance for its HOLOSCOPEtm-i holographic system. The system creates spatially accurate, three-dimensional interactive medical holograms, based on data received from standard CT...

Galmed Pharmaceuticals Ltd. ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases announced today that the FDA agreed with its plan to use Aramchol meglumine (in lieu of Aramchol free...

Alkermes plc  today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the...

Protalix BioTherapeutics, Inc. , a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today...

Epygenix Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare and intractable genetic epilepsy, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to EPX-200 for the treatment of...

Expanded authorization enables use of REGEN-COV for post-exposure prophylaxis in certain people exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual in an institutional setting Supported by...

KeifeRx, LLC, an emerging clinical-stage biotechnology company specializing in the discovery and development of new treatment options for neurodegenerative diseases, announced today that the company received an acceptance of its Investigational New...