Potential for Covid 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 Covid vaccine to be ready by Spring 2021 during a virtual conference last Thursday (5/8). He says that while there may be...
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 Eli Lily's Retevmo, a drug which treats three kinds of tumors associated with lung and thyroid cancer: non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers. This comes as the...
Moderna Moves into Phase 2 of Covid 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 Tests
The FDA announced that it would strengthen its oversight for companies marketing the Covid 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...
FDA Grants EUA for Covid Treatment Remdesivir from Gilead
The FDA announced today (5/1) that it would grant EUA for Gilead for their antiviral drug remdesivir for treatment in early response to suspected or confirmed patients with Covid. This authorization will allow the distribution of the drug all over the US, as well as...
FDA Announces Exemptions and Exclusions from Certain Requirements in the Drug Supply Chain Security Act
Yesterday (4/30) the FDA lifted some of the security requirements in the Drug Supply Chain Security Act to help expedite adequate distribution of prescription drugs due to COVID-19. These exemptions and exclusions apply to...
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