News by subject: FDA

MOVIA Robotics, Inc. is pleased to be expanding its work in social emotional learning as they launch their TheraPal Progress Tracker, TheraPal Home, and TheraPal Clinical Assist Aides for Autism Spectrum Disorder (ASD) and other Intellectual or...

Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track...

The U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients from birth to <12 years old, Eli Lilly and Company...

Today, the U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to...

Biotheus Inc., has announced that its proprietary anti-PD-L1/TGF-? bifunctional therapeutic, named PM8001, has been approved by the USFDA (United States Food and Drug Administration) for conducting clinical phase II studies as part of an...

Tryp Therapeutics ("Tryp" or the "Company"), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs, announced today that it has received confirmation from the U.S. Food and Drug...

Chemomab Therapeutics, Ltd. (Chemomab), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, today announced that the U.S. Food and Drug...

The Bone Scoretm assessment is a fundamentally new approach to measuring bone. Using groundbreaking technology, the assessment introduces established engineering principals to the field of bone health by enabling physicians to physically test bone...

Inhibrx, Inc. , a biotechnology company with four clinical programs in development and a strong emerging pipeline, today announced that the U.S. Food and Drug Administration, or FDA, has granted orphan-drug designation for INBRX-109 for the treatment...

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

Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX FASPRO® (daratumumab and...

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 Kyprolis® (carfilzomib) and dexamethasone (Kd)...

LumiraDx  announced today that the intended use for its Food and Drug Administration (FDA) Emergency Use Authorization (EUA) SARS-CoV-2 RNA STAR Complete, a rapid, nucleic acid amplification technology for high sensitivity, high throughput COVID-19...

Insightec, a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy, announced today that the Exablate Prostate system received FDA 510K clearance for treating prostate tissue with...

DRI Healthcare Trust ("DRI" or "the Trust") today announced that it has been notified by CTI BioPharma Corp. (CTI) that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application for pacritinib for the...

CTI BioPharma Corp. today announced the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for pacritinib for the treatment of adult patients with intermediate or high-risk primary or secondary...

metaMe Health, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for Regulora®, the first FDA-authorized treatment of any kind specifically for abdominal pain associated with irritable bowel syndrome (IBS) in...

Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced that SeptiCyte® RAPID has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The cleared test is...

SprintRay Inc., an industry leader in digital dentistry and 3D printing solutions, today announced that the United States Food and Drug Administration (FDA) has granted the Company clearance to market its NightGuard Flex 3D printing resin as a Class...

PrecisionOS® has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market InVisionOStm a patient specific planning tool using Virtual Reality (VR). The patented software, to be available in early 2022, lets surgeons use...

Respira Technologies, Inc announced today, after a successful and collaborative Pre-IND meeting with FDA's Center for Drug Evaluation and Research (CDER), the company plans to submit an IND to FDA in 2022 to support its prescription combination drug...

AMF Medical is proud to announce that its Sigitm Insulin Management System, for diabetes mellitus treatment, has met the criteria and has been granted Breakthrough Device Designation by the US Food and Drug Administration.  ...

Cumberland Pharmaceuticals Inc. , a specialty pharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has approved expanded labeling for Caldolor®, an intravenously delivered formulation of ibuprofen, to now include use in...

Tetra Bio-Pharma Inc. ("Tetra" or the "Company")  (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development today announced that it received a letter from the United States Food and Drug Administration (FDA), granting a Type C...

On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent imaging agents to target and illuminate cancer during surgery, today announced that the U.S. Food and Drug Administration (FDA) has approved CYTALUX for adult...

The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue...

LensGen, Inc., a privately held ophthalmic medical device company, announced today that it has received approval for an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal study of the...

Hyperfine, Inc., creator of the first FDA-cleared portable magnetic resonance imaging (MRI) device, Swoop®, today announced the FDA 510(k) clearance and launch of its new advanced image reconstruction technology using deep learning (DL). The image...

Today, the U.S. Food and Drug Administration approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV)...

Isofol Medical AB (publ) , announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the development of the Company's lead drug candidate arfolitixorin, the stabilized and biologically active pure...

Pittsburgh Life Science Greenhouse (PLSG) is proud to share that one of its portfolio companies, ALung Technologies, Inc. (ALung), announced that the Food and Drug Administration (FDA) has granted the company De Novo clearance for the Hemolung...

The FDA has granted approval of multi-dose vial presentation for AUDENZtm to help protect individuals six months of age and older against influenza A(H5N1) in the event of a pandemic.1 As the first-ever adjuvanted, cell-based influenza vaccine,...

Today, Motilent, the first company to specialize in the assessment of digestive diseases using AI medical image analysis, announces FDA 510K clearance in the USA. The rollout of this technology will be in partnership with Nuance AI solutions....

Cardiologs announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to use its AI-powered cardiac diagnostics platform for pediatric cardiology....

Potential one-time gene therapy for the treatment of Duchenne, includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV® AAV8 vector Commercial-scale cGMP material to be used in clinical development Company on track to...

Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Medical Device designation to its Osteo-Adapt SP Spinal...

Vela Diagnostics announced today that the ViroKey® SARS-CoV-2 RT-PCR Test v2.0 that received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), can now be used with the KingFisher FLEX system and Hamilton Microlab...

BioMarin Pharmaceutical Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VOXZOGOtm (vosoritide) for Injection, indicated to increase linear growth in pediatric patients with achondroplasia...

Today, the U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates), meaning these children still have the potential to...

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after...

Datar Cancer Genetics Inc, a leading cancer research company focussed on early detection of cancers today announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its 'TriNetratm' blood test to detect...

Datar Cancer Genetics, a leading cancer research company focussed on early detection of cancers today announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its blood test to detect early-stage...

Longeviti Neuro Solutions, developer of the first low-profile intracranial devices that meets the functional and reconstructive needs of brain surgery patients, recently announced that it was granted a 510(k) clearance by the U.S Food and Drug...

Lunit, a leading medical AI provider, today announced that the US Food and Drug Administration (FDA) 510(k) has cleared its AI solution for breast cancer detection, 'Lunit INSIGHT MMG'. Along with its chest x-ray triaging solution 'Lunit INSIGHT CXR...

Mirati Therapeutics, Inc. , a clinical-stage targeted oncology company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate the Company's synthetic lethal...

FibroBiologics, a clinical stage company developing fibroblast-based therapeutic cures for chronic diseases, announced today that it has signed an agreement with GEM Global Yield LLC SCS (GEM), a private investment group, with offices in New York and...

Blackrock Neurotech, the leader in brain-computer interface technology, today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its groundbreaking MoveAgain Brain Computer Interface (BCI)...

Sofwave Medical Ltd , an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, today announces that the U.S. Food and Drug Administration (FDA) approves clearance of additional indications, for lifting...

MimiVax LLC, a clinical-stage biotechnology company in Buffalo, NY, USA, developing immunotherapeutics for cancer and autoimmune diseases, announced today that the company has received a "Study May Proceed" notification from the United States Food...

InnoCare Pharma (HKEX: 09969), a commercial-stage biotech company, announced today the Investigational New Drug (IND) clearance of its SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor ICP-189 by the US Food...