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The FDA has expanded the Emergency Use Authorization (EUA) for Pfizer and BioNTech’s mRNA-based vaccine, allowing the inoculation to be used in patients 12 to 15 years old. Read More
AstraZeneca (AZ) may forgo seeking Emergency Use Authorization (EUA) from the FDA and instead go for full approval for its COVID-19 vaccine off the bat. Read More
Inovio said the results from the 400-person phase 2 study will help answer the agency’s questions and that the phase 3 trial will advance once the hold is lifted. Read More
First to receive Emergency Use Authorization (EUA) for their highly effective COVID-19 vaccine, Pfizer and BioNTech have now become first to submit a biologics license application (BLA) with the FDA for full approval of their inoculation. Read More
President Biden made headlines this week by voicing strong support for waiving COVID-19 vaccine intellectual property (IP) rights during the pandemic, but any deal hashed out at the World Trade Organization (WTO) could come too late to make a significant impact. Read More
The FDA said yesterday that it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September. Read More
President Biden will support a World Trade Organization (WTO) proposal to waive patent protections for COVID-19 vaccines during the pandemic, marking a seismic shift in U.S. policy on intellectual property protections. Read More