Today (9/28), Hologic received emergency use authorization (EUA) from the FDA for their testing kit for individuals with no symptoms of COVID-19. The CDC recently rescinded their statement saying that asymptomatic people did not need to be tested for COVID-19 and...
The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to...
Amidst the COVID-19 public health crisis, many companies have worked tirelessly to perfect testing technology. Assure Tech, a Chinese company based in Hangzhao, has prevailed with an antibody test with emergency use authorization. This is the first time that the FDA...
With the incoming implementation of the EU Clinical Trial Regulation 536/2014 in December 2021, Parexel, an end-to-end innovative therapeutics solutions provider, has announced the launch of their Regulatory Submissions Hub Service for their life science and...
In the most recent report from the UK this past week, cases of COVID-19 have doubled to about 6,000 per day. While infections have been on a slow and steady increase in Europe over the last two months, especially in Spain and France, governmental bodies are...
A study participant participates in a clinical trial, contributing invaluable data to understanding the safety and efficacy profile of a drug. Yet, patients, despite risking their lives by participating in a clinical trial, don’t usually get to know the outcome of the...
Orphazyme, a biotech company based in Denmark, announced today (9/16) that the FDA has accepted its New Drug Application (NDA) for treatment of Niemann-Pick disease Type C. The genetic disease is both rare as well as fatal, with no currently approved...
The National Institute for Health and Care Excellence (NICE) originally rejected global biopharmaceutical company AstraZeneca’s lung cancer therapy Tagrisso (Osimertinib), but has since decided to reverse its initial decision. NICE initially did not recommend Tagrisso...
Edwards Lifesciences has developed the Sapien 3 transcatheter heart valve for cardiac treatment which was approved yesterday (9/8) by the U.S. Food and Drug Administration (FDA) for pediatric and adult patients. Transcatheter heart valves is an option for the new...
BeyondSpring, a global biopharmaceutical company focusing on immune-oncology therapy treatments for cancer patients, received today (9/8) breakthrough therapy designations (BTD) from the U.S. Food and Drug Administration (FDA) as well as the China National Medical...
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