Neuralink, the neurotech startup co-founded by Elon Musk, has received approval from the Food and Drug Administration to conduct its first in-human clinical study of its brain implant device. The device, called the Link, is designed to help patients with severe paralysis control external technologies using only neural signals. This means patients with severe degenerative…
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Trendlines Group’s ApiFix receives FDA regulatory approval
MISGAV, ISRAEL: The Trendlines Group Ltd. announced on Wednesday that its portfolio company ApiFix Ltd., a leading scoliosis correction company and one of Trendlines’ ten most valuable companies, received regulatory approval from the United States Food and Drug Administration (FDA) to commercialize its MID-C System for motion-preserving deformity treatment of progressive adolescent idiopathic scoliosis (AIS)….
Genus posts strong FY25 results, accelerates China JV and FDA milestone boosts profit
Adjusted profit before tax surged 24% to £74.3 million, driven by broad-based growth LONDON: Genus plc reported a robust financial performance for the year ended June 30, 2025, with adjusted profit before tax rising 24% to £74.3 million, driven by broad-based growth across its porcine and bovine genetics businesses and strategic progress in China. Adjusted…
Alzheimer treatment granted fast track designation by the FDA
STOCKHOLM: BioArctic AB’s partner Eisai announced today that lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. Breakthrough Therapy designation and Fast Track…
Diurnal receives agreement from US FDA
LONDON, UK: Diurnal Group plc announced the US Food and Drug Administration (FDA) has agreed a Special Protocol Assessment (SPA) for Chronocort (modified-release hydrocortisone) for the design, endpoints and statistical analysis approach of a pivotal study of Chronocort for the treatment for Congenital Adrenal Hyperplasia (CAH) in the US. The SPA provides agreement that the…
PRA Health Sciences appoints senior FDA official Isaac Rodriguez-Chavez
RALEIGH: PRA Health Sciences Inc. announced the appointment of Isaac Rodriguez-Chavez, PhD, MHS, MS, as Senior Vice President, Scientific and Clinical Affairs. He will lead the company’s Global Center of Excellence for Decentralized Clinical Trial (DCT) Strategy. Dr. Rodriguez-Chavez’s responsibilities will involve the continued growth and development of PRA’s industry-leading decentralized clinical trial strategy, regulatory…
U.S. FDA approves Gilead’s antiviral Veklury (remdesivir) for treatment of COVID-19
FOSTER CITY: Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Previously authorized by the FDA for emergency use…
FDA Approves initiation of IGC’s cannabinoid trial on Alzheimer’s patients
POTOMAC: India Globalization Capital announced that on July 30, 2020, the U.S. Food and Drug Administration (FDA) notified IGC that it has authorized the Company to initiate a Phase 1 human trial study for the Company’s investigational cannabinoid formulation for the treatment of patients suffering from mild to severe dementia due to Alzheimer’s disease. After…
Aroa Biosurgery secures FDA clearance for Symphony
PERTH: Aroa Biosurgery Limited has received clearance from the U.S. Food and Drug Administration (FDA) for new product Symphony, which is designed to reduce the time to wound closure, particularly where patients have severely impaired healing or are compromised by other diseases. Aroa Chief Executive Brian Ward said that following the FDA clearance, which was…
Algernon receives ethics approval for U.S. sites for human study of ifenprodil for covid-19
VANCOUVER: Algernon Pharmaceuticals Inc., a clinical stage pharmaceutical development company, has received ethics approval from a central institutional review board for U.S. study sites for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for COVID-19. Ifenprodil is an NMDA receptor antagonist specifically targeting the NMDA-type subunit 2B. The Company has also signed agreements with…
Akili receives approval to market EndeavorRx in Europe as a digital treatment for children with ADHD
LONDON: PureTech Health’s founded entity, Akili Interactive has received a Conformité Européenne (CE) Mark for EndeavorRx (AKL-T01) as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in paediatric patients with Attention Deficit Hyperactivity Disorder (ADHD). While EndeavorRx is not yet available in Europe, the CE Mark enables Akili…
FDA consultant Anita Nosratieh joins Izotropic Advisory Board
VANCOUVER: Izotropic Corporation announced Anita Nosratieh Ph.D., as a new member of the Company’s Advisory Board. Nosratieh began her career as a lead reviewer at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) where she worked with companies seeking approval of breast cancer screening and diagnostic devices. As lead reviewer,…