News by subject: FDA

The U.S. Food and Drug Administration today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular...

Brand Institute is proud to announce its role in naming all three COVID-19 vaccine brand names recently approved by Health Canada: Comirnaty® (Pfizer/BioNTech), Spikevax® (Moderna), and Vaxzevria® (AstraZeneca). In addition to approving the brand...

Neurelis, Inc. announced today that it has initiated a clinical program to investigate the use of  VALTOCO® (diazepam nasal spray) in children with epilepsy aged two to five as a treatment for seizure clusters. VALTOCO is currently approved by the...

Abbott today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Porticotm with FlexNavtm transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high...

The U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab 700 mg and etesevimab 1400 mg administered together to include post-exposure prophylaxis (PEP) in certain individuals for the prevention...

TriviumVettm, an animal health research and development company focused on addressing unmet needs in companion animal medicine, today announced that the Food and Drug Administration's Centre for Veterinary Medicine has determined that the company can...

Golden Biotechnology Corp.(TPEx:4132) ("GoldenBiotech", GBC), a leading Taiwanese biopharmaceutical company, announces that its oral investigational new drug Antroquinonol (HOCENA®) has made headway with COVID-19 treatment development in more broaden...

Camurus today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for the company's investigational medicinal product, octreotide subcutaneous depot (CAM2029), for the treatment of autosomal dominant...

The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with epidermal growth factor receptor (EGFR) Exon20 insertion...

Following Amylyx's announcement that it intends to submit a New Drug Application (NDA) for AMX0035, The ALS Association today urges the Food and Drug Administration to approve the treatment for all people with ALS as soon as possible. The Association...

Calliditas Therapeutics AB (publ) ("Calliditas" or the "Company") , a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced that the U.S. Food and Drug Administration (FDA)...

Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert Xpress CoV-2/Flu/RSV plus, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19,...

ISA Pharmaceuticals B.V., a clinical stage biotech company developing immunotherapies to treat cancers and infectious diseases, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product ISA101b,...

Visby Medicaltm announced today that its instrument-free Reverse Transcription (RT)-Polymerase Chain Reaction (PCR) COVID-19 test was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for testing pooled patient...

Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets, today announced that the U.S. Food and Drug Administration (FDA) has approved the initiation of a Phase 1...

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Jardiance® (empagliflozin) as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF), Boehringer Ingelheim and Eli...

Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the Office of Orphan Products...

Soin Therapeutics, a pharmaceutical company based in Dayton, OH, was granted orphan drug status from the FDA for low dose naltrexone (LDN) to treat complex regional pain syndrome (CRPS)....

Intelivation Technologies, a medical device company with a growing product portfolio announced today that they have achieved FDA 510(k) Clearance of the Advantage-Ctm PEEK Cervical Interbody Fusion device....

NeuroOne Medical Technologies Corporation (NeuroOne or the Company), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it has received U.S....

Sensient Technologies Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved a petition filed by Sensient's Color Group to add butterfly pea flower extract to the list of approved color additives in the United...

TransMedics Group, Inc. ("TransMedics") , a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has...

RenovoRx, Inc. , a biopharmaceutical company and innovator in targeted cancer therapy, today announced it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its proprietary RenovoCath Delivery System. The...

Omeza, a skin science company, announced today the U.S. Food and Drug Administration (FDA) cleared Omeza® Collagen Matrix through the FDA 510(k) premarket notification process. Omeza® Collagen Matrix is Omeza's first Rx product, and the first...

Oncopeptides AB (publ) , a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the US Food and Drug Administration, FDA, has announced a forthcoming public advisory...

KAHR, a cancer immunotherapy company developing novel multifunctional immuno-recruitment proteins, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for KAHR's Phase 1b...

The U.S. Food and Drug Administration has provided 510 (k) Clearance for Prelivia, a neurostimulation device developed by Rehabtronics that promotes healthy blood circulation and maintains healthy tissue in people who are bedridden or chair bound....

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERAtm (6-month paliperidone palmitate), the first-and-only twice-yearly...

Intelivation Technologies, a medical device company with a cutting-edge spinal implant product portfolio announced today that they have achieved FDA 510(k) Clearance of the Golden Isles Pedicle Screw Systemtm....

MiRus LLC, the leading innovator in rhenium-based superalloy medical implants announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its IOtm Expandable Lumbar Interbody....

SAM? (Sustained Acoustic Medicine), ZetrOZ's clinically proven, noninvasive pain relief device, will be on display at the 2021 Academy of Orthopaedic Surgeons (AAOS) in San Diego, California, from Aug. 31-Sept. 3.  As a rule, orthopaedic surgeons...

HUYABIO International (HUYABIOtm), the leader in accelerating global development of China's pharmaceutical innovations, announced today the filing of an investigational new drug application (IND) with the FDA for HBI-2376 along with Genhouse who has...

MicroTransponder, Inc. today announced United States Food and Drug Administration (FDA) Premarket Approval of the Vivistim Paired VNStm System, which significantly improves the effectiveness of rehabilitation therapy for stroke survivors with...

InnoCare Pharma (HKEX: 09969), a commercial-stage biopharmaceutical company, announced today the Investigational New Drug (IND) clearance of its second-generation pan-TRK inhibitor ICP-723 by the US Food and Drug Administration (FDA) for starting...

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...

Poseida Therapeutics, Inc. , a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that the U.S. Food and Drug...

UCB announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BRIVIACT (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month of age.2...

Visby Medicaltm announced today that it has received a 510(k) clearance and was granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) from the US Food and Drug Administration (FDA) to market its fast, single-use...

Polaryx Therapeutics, Inc. ("Polaryx"), a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation for PLX-200 to...

The U.S. Food and Drug Administration today approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits...

Thermo Scientific EliA SmDP-S test has been cleared by the U.S. Food & Drug Administration (FDA) for aiding the diagnosis of Systemic Lupus Erythematosus (SLE), the most common type of lupus. This new test enhances specificity without sacrificing...

FX received 510k clearance for its lateralized and augmented glenoid baseplates.  With these additions, FX brings ten additional glenoid baseplate options to the market.  The glenoid baseplates are available in 24mm options with additional...

Servier Pharmaceuticals, a growing leader in oncology committed to bringing the promise of tomorrow to the patients we serve, announced today that the U.S. Food and Drug Administration (FDA) approved TIBSOVO® (ivosidenib tablets) for the treatment of...

BD (Becton, Dickinson and Company) , a leading global medical technology company, announced today the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the BD Veritortm At-Home COVID-19 Test ? the first...

The U.S. Food and Drug Administration (FDA) has granted pre-market approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma...

Medtronic plc , the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evoluttm FX TAVR system....

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...