Oct 20, 2021 | News, Regulatory
In a first for the industry, New York Surgeons at NYU Langone Health have successful transplanted a pig kidney into a human without an immediate immune system rejection. The successful transplant is a major breakthrough which has the potential to alleviate a stark...
Oct 19, 2021 | News, Regulatory
Hyloris Pharmaceuticals SA, known for reinventing exciting medications for unmet medical needs, has announced the approval of Maxigesic® IV, in the UK and Ireland. Maxigesic IV is a unique concoction of of 1000mg paracetamol and 300mg ibuprofen solution for infusion...
Oct 18, 2021 | FDA, News, Regulatory
Oyster Point announced that its nasal spray will become available next month for patients with a prescription, making it the first FDA-approved nasal spray in the US for chronic dry eye disease. The drug is aimed at filling the unmet medical need for people who suffer...
Oct 14, 2021 | Clinical Trials, Health, Healthcare, News, Regulatory
According to a systematic review consisting of 57 studies and including 250,000+ patients, more than 50% patients with long COVID (persistent postacute sequelae of COVID-19 or PASC) described feeling effects of COVID beyond six months after recovery. The results...
Oct 14, 2021 | Health, News, Regulatory
electroCore, a leading bioelectronic medicine company, have received a revised Medical Device License (MDL) from Health Canada to extend its labelling of electroCore’s gammaCore nVNS to include the acute and preventive treatment of migraine in adolescents (aged 12...
Oct 13, 2021 | Health, News, Regulatory
Eli Lilly and Company has received FDA approval from the US FDA (Food and Drug Administration) for the first and only CDK4/6 inhibitor for a specific group of people with Breast Cancer. Verzenio, abemaciclib, aims to treat adult patients with hormone receptor-positive...
Oct 12, 2021 | News, Regulatory
Genematrix, known for their real-time PCR based molecular diagnostics, have announced that NeoPlex HPV29 Detection has gained European Medical Device Certification (CE-IVD). Designed to simultaneously diagnose 29 genotypes of human papillomavirus (HPV – a key...
Oct 11, 2021 | News, Regulatory
A global leader in medical technology, Medtronic, has been granted CE (Conformité Européenne) Mark for the Hugo™ robotic surgery (RAS) system, giving the green light for sales of the system in Europe. The approval has been given for urologic and gynecologic procedures...
Oct 8, 2021 | Health, Healthcare, Medical Translation, Medical Writing
For those following our series on AI in communications, or for anyone closely watching developments in the life sciences, it won’t come as news that technology is one of the most promising new tools for solving challenges in health care and developing new treatments....
Oct 8, 2021 | News, Regulatory
ChemoCentryx has received US FDA (Food and Drug Administration) approval for their drug, avacopan, to treat the rare, fatal autoimmune disease, antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV). The oral drug, brand name Tavneos, will help those...
