FDA Releases Guidance on Formal Meetings Amid COVID-19 Crisis
The FDA announced on Wednesday (5/27) new guidances via a Q&A format for how COVID-19 is impacting formal meetings, effective immediately. The guidance outlines that all meetings with the FDA will be held remotely, either through teleconference or video...
Moderna Notes Early Signs of Success in COVID-19 Vaccine
Today (5/18) Moderna announced that its clinical trial in the United States has started to see protective antibodies in data from 8 healthy individuals, chosen at random from a 45-person study. The study, which began in March, and found that the...
Potential for COVID-19 Vaccine to be Approved Within a Year, According to EMA Official
Marco Cavaleri, the European Medicines Agency’s (EMA) top official overseeing anti-infectives and vaccines, acknowledged the potential for a vaccine for COVID-19 to be ready by Spring 2021 during a virtual conference last Thursday (5/8). He says that while...
FDA Approves Eli Lilly’s Retevmo, the First Treatment for Patients with a Certain Genetic Mutation for Lung and Thyroid Cancers
The FDA announced on Friday (5/8) of its approval for Retevmo, a drug capsule created by Eli Lilly for patients diagnosed with a specific RET gene mutation for three kinds of tumors: non-small cell lung cancer, medullary thyroid cancer and other types of thyroid...
Moderna Moves into Phase 2 of COVID-19 Vaccine
In their business update, Moderna announced they received FDA clearance to move into Phase 2 of their study for the COVID-19 vaccine. In their press release, they also reported additional funding from Biomedical Advanced Research and Development Authority (BARDA) as...
FDA Amends Policy for COVID-19 Tests
The FDA announced that it would strengthen its oversight for companies marketing the COVID-19 serology tests. After questions came to light in regards to the accuracy of some of the testing kits, the FDA is now requiring commercial manufacturers to submit an emergency...
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