News by subject: FDA

Biostar Pharma, Inc. (hereinafter referred to as "Biostar"), the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of...

PathKeeper Surgical, a privately-held, Israel-based, medical technology company, dedicated to improving the health of individuals around the world suffering from all spinal issues requiring surgery, while making navigation-guided surgery available to...

Nordic Bioscience, a leading biomarker...

Today, leading FDA service, software, and training firm, Registrar Corp, announced the launch of a new, 100% online cosmetics Good Manufacturing Practices (GMP) training course. The Cosmetics GMP Online Training course covers ISO 22176 guidelines for...

Life Recovery Systems (LRS) has received concurrence from the US Food and Drug Administration (FDA) to successfully end its pilot study (SISCO) with the ThermoSuit® System in the treatment of ischemic stroke and move forward with a prospective...

Brand Institute is proud to announce its work in developing the brand name VEVYEtm (cyclosporine ophthalmic solution) from Novaliq. VEVYE was approved by the U.S. Food and Drug Administration (FDA) on May 30, 2023, for the treatment of the signs and...

Evergreen Theragnostics, Inc. and PharmaLogic Holdings Corp., announced their agreement for PharmaLogic to prepare, sell, and distribute OCTEVYtm (Kit for Preparation of Ga 68 DOTATOC Injection), if approved by the United States Food & Drug...

Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today announces it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its AETOS Shoulder System....

Huma Therapeutics ("Huma"), a leading global digital...

CorNeat Vision's EverPatch, a synthetic tissue substitute, has been granted 510(k) clearance by the US Food & Drug Administration (FDA). The CorNeat EverPatch is the first synthetic, non-degradable tissue-integrating matrix for use in ophthalmic...

Today, an Advisory Committee to the Food and Drug Administration (FDA) unanimously endorsed the efficacy and clinical benefit of lecanemab (Leqembitm, Eisai) as part of the traditional approval process for this treatment....

Today, the FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that lecanemab (leqembi) showed clinical benefit in early Alzheimer's disease, paving the way for a traditional approval of the drug....

CorNeat Vision's EverPatch, a synthetic tissue substitute, has been granted 510(k) clearance by the US Food & Drug Administration (FDA). The CorNeat EverPatch is the first synthetic, non-degradable tissue-integrating matrix for use in ophthalmic...

Innova Vascular, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Laguna Clot Retrievertm System and its Malibu Aspiration Cathetertm System for use in the peripheral vasculature. The two new...

OnQuality Pharmaceuticals ("OnQuality"), a targeted oncology supportive therapy company developing innovative medications to address unmet needs in oncodermatology and oncogastroenterology (cancer therapy-induced toxicities occurring in the skin and...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to...

Artelon Inc., announced today U.S. FDA 510(k) clearance of FlexBand®, FlexPatch®, and FlexBand Plus® for ligament repair surgery in addition to tendon repairs*. This new clearance expands the indications for these products to now include...

DeepX Diagnostics Inc., the skin cancer teledermatology and diagnostics company, announced today that its digital dermatoscope DermoSightTM received clearance from the US Food and Drug Administration (FDA) for teledermatology screening of suspect...

CSL Vifor today announced that the U.S. Food and Drug Administration (FDA) has granted its partner American Regent, Inc., a Daiichi Sankyo Group company, approval for Injectafer® for the treatment of iron...

Galderma announced today the U.S. Food and Drug Administration (FDA) approved Restylane® Eyelight for the treatment of undereye hollows, also known as dark shadows, in adults over the age of 21.1 Restylane Eyelight, an undereye hyaluronic acid (HA)...

Kyverna Therapeutics ("Kyverna"), a cell therapy company with the...

The Alzheimer's Association recognizes that the Centers for Medicare & Medicaid Services (CMS) has announced their conceptual approach to fulfill their commitment to immediate coverage of Food and Drug Administration (FDA) traditionally approved...

Penumbra, Inc. , a global healthcare company focused on innovative therapies, announced the U.S. Food and Drug Administration (FDA) clearance and launch of Lightning Bolttm 7, the most advanced and powerful arterial thrombectomy...

YS Biopharma Co., Ltd. ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and...

?  HPV is responsible for more than 90 percent of cervical cancer cases globally with approximately 300,000 women living with cervical cancer in the US ? ?  Current response rates to second line treatments in recurrent or metastatic cervical cancer...

Bausch Health Companies Inc. and its oral health care business, OraPharma, today announced its collaboration with World Series Champion, Alex Rodriguez, to launch a national awareness campaign about the prevalence and impact of gum disease. The...

THINK Surgical, Inc. recently announced that its TMINItm Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)....

THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINItm Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)....

Brand Institute is proud to announce its work in developing the brand name Opveetm (nalmefene) Nasal Spray from Indivior (through its wholly owned subsidiary, Opiant Pharmaceuticals, Inc.), which was approved by the U.S. Food and Drug Administration...

ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic medical devices, has received approval for its Investigational Device Exemption (IDE) application...

QuantalX, the developer of Delphi-MD, a novel point-of-care neurodiagnostic device, has announced that they have received the prestigious FDA breakthrough designation medical device status for another...

Inhibrx, Inc. , a clinical-stage biopharmaceutical company dedicated to the development of therapeutics for oncology and rare diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to INBRX-101, an...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking...

The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's Sirolimus Coated Balloon (SCB) MagicTouch  PTA for the treatment of Superficial Femoral Arteries (SFA). This marks the fourth...

Pulse Medical Technology, Inc. (Pulse Medical) 4th generation ?FR® system has received an FDA Breakthrough Device designation.  Pulse Medical, founded in 2015, located in Shanghai, China, is dedicated to developing innovative technology for precise...

Catching cancer earlier and achieving more accurate initial diagnostics are two of the key benefits of breakthrough artificial intelligence technology that a European company is now bringing to U.S. patients. For Quibim, a leading provider of imaging...

Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to...

StemCyte announced it has officially begun recruiting patients under a US Food and Drug Administration (FDA) approved Phase IIa human clinical trial in the United States. This is the world's first Phase II trial using umbilical cord blood cells to...

Human Immunology Biosciences (HI-Biotm), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced that the U.S. Food and Drug Administration (FDA) has granted...

Numinus...

Camurus today announces that the US Food and Drug Administration (FDA) has approved Brixaditm (buprenorphine) extended release injection for subcutaneous (SC) use, a weekly and monthly medication for the treatment of moderate to severe opioid use...

Today, the U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by...

Today, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations, a weekly...

Braeburn announces that the U.S. Food and Drug...

Cumberland Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for a Phase II study in patients with Idiopathic Pulmonary Fibrosis, the most common form of...

Women's Health Interactive, an online publisher exclusively focused on fearless conversations about sex and sexuality, has teamed up with AH! YES and their quest to Make Vaginas Happy®. This unique partnership is designed to promote sexual intimacy...

Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI,...

Artivion, Inc. , a leading cardiac and vascular surgery company focused on aortic disease, today announced that the U.S. Food and Drug Administration (FDA) granted premarket application (PMA) approval of PERCLOT Absorbable Hemostatic System...

RMAT recognizes that the preliminary clinical evidence from RGX-121, a potential one-time AAV Therapeutic, indicates the potential to address unmet medical needs for MPS II RMAT designation is for gene therapies intended to treat or cure serious...

Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology...