As we get closer and closer to the day that the FDA has to release its first batch of 55,000 pages of clinical trial documents, it looks like Pfizer is bracing for impact. That’s because it was just revealed that Pfizer updated its fourth-quarter investor report—the section on potential risks to their business. Specifically, they…
Facts Matter (Feb. 9): Pfizer Quietly Adds Warning That ‘Unfavorable Pre-Clinical, Clinical, or Safety Data’ May Impact Business
Fire The FDA
Commentary The late, great economist Milton Friedman used to point to the Food and Drug Administration as an example of a government agency that killed tens of thousands of people every year. This declaration stunned and even enraged people. How could an agency that is supposed to help develop, test, and certify the safety of…
FDA Recalls ‘Illegally Imported’ At-Home COVID-19 Tests
The U.S. Food and Drug Administration (FDA) announced the recall of an at-home COVID-19 test because they have been illegally imported into the United States. SD Biosensor Inc. confirmed to the FDA that it is voluntarily recalling its Standard Q COVID-19 Ag Home Test over “confirmed reports that the test kits were illegally imported into the…
Court Temporarily Blocks Pfizer’s Motion to Intervene in Vaccine Information Case
A federal judge on Feb. 7 denied, for now, an attempt from Pfizer to intervene in a case that has drawn international attention. U.S. District Judge Mark Pittman, a Trump nominee, said that Pfizer may be allowed to intervene in the future but not at this time. The case concerns documents on Pfizer’s COVID-19 vaccine…
INFOGRAPHIC: Approved and Non-FDA Approved COVID-19 Treatments
Since the onset of the COVID-19 pandemic two years ago, hundreds of studies have examined the efficacy of dozens of drugs and other compounds in treating the disease. While the research is still ongoing, a sizable number of treatments have shown promise. A growing number of them have been authorized by the U.S. government, though…
CDC Signals Changes to COVID-19 Vaccine Schedule, in Part to Address Heart Inflammation
The Centers for Disease Control and Prevention (CDC) on Feb. 4 outlined an expected change to the COVID-19 vaccine schedule for people with weak immune systems and signaled that a different alteration is coming for the general population to try to cut the number of post-vaccination heart inflammation cases. The CDC told its vaccine advisory…
FDA Restores Document on Moderna COVID-19 Vaccine Approval After Pressure From Epoch Times, Lawmakers
The Food and Drug Administration (FDA) has restored a document outlining why it approved Moderna’s COVID-19 vaccine, days after the regulatory agency pulled the 30-page file offline after receiving questions about it from The Epoch Times. No explanation has been given for why the document vanished hours after the questions were sent, but the removal…
FDA Restores Document on Moderna COVID-19 Vaccine Approval After Inquiries by Epoch Times, Lawmakers
The Food and Drug Administration (FDA) has restored a document outlining why it approved Moderna’s COVID-19 vaccine, days after the regulatory agency pulled the 30-page file offline after receiving questions about it from The Epoch Times. No explanation has been given for why the document vanished hours after the questions were sent, but the removal…
FDA Restores Document on Moderna COVID-19 Vaccine Approval After Outcry
The Food and Drug Administration (FDA) has restored to its website a document that outlines why it approved Moderna’s COVID-19 vaccine, days after the regulatory agency pulled the 30-page file offline after receiving questions about it from The Epoch Times. No explanation has been given for why the document vanished hours after the questions were…
FDA, Doctors’ Group Reach Agreement on Production of Pfizer Vaccine Documents
A group seeking all the documents analyzed by U.S. drug regulators before approving Pfizer’s COVID-19 vaccine has reached an agreement with the government on how fast the documents will be produced. The Food and Drug Administration (FDA) must produce 10,000 pages by March 1 and another 10,000 pages by April 1 in response to the…
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