FDA expands COVID vaccine warning about possible side effect NIH scientists to be laid off, despite what RFK Jr. told Congress Changes at Trump's DOJ could shift which local police agencies get grants More from CBS News Who can get updated COVID vaccines this fall? FDA tightening rules ...
The first group will have received two doses of the current Pfizer-BioNTech COVID-19 vaccine 90 to 180 days prior to enrollment. In the new study, participants will receive one or two doses of the Omicron-based vaccine. In the second group, participants will have received thr...
The FDA’s vaccine chief, Dr. Peter Marks, told The Associated Press Friday the agency will rapidly evaluate COVID-19 vaccinations for younger children as soon as it gets the needed data. Pfizer is expected to turn over its study results by the end of September. Marks ...
That's Reuters Ryan Chang. Drugmaker Pfizer is asking the Food and Drug Administration to approve booster shots for its COVID-19 vaccine. AP's Ben Thomas reports. Pfizer's two-shot vaccine received full regulatory approval from t...
Regardless of whether an SAE occurs in the course of clinical practice or during a clinical trial, and regardless of where it is first reported, an NDA or BLA holder who is also the sponsor of an IND investigating the same drug for CO...
Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older.View Get Alert AZNAZNCF AstraZeneca PLC DurvalumabTreatment Of Locally Advanced Or...
In the third quarter of 2023, Paxlovid brought in just $202 million, echoing a similar revenue fall for Pfizer’s Comirnaty COVID vaccine. This comes as the emergency stage of the pandemic has drifted into an endemic one, leading to a major drop-off in demand for COVID sho...
Anthony Fauci on his thoughts regarding the recent spikes in cases, the potential for a COVID-19 vaccine by next year, and promising therapeutics in the pipeline. The interview link is given below however I will summarize a few of the highlights of the interview. Some notes on the interview...
Policy FDA Launches Probe of Malignancies Linked to CAR-T Therapies The agency on Tuesday said it is investigating the “serious risk” of T cell malignancy outcomes, including hospitalization and death, and evaluating the need for potential regulatory action. ...
the 1980s, going from 26 manufacturers to 4, after lawsuits claiming $3.5 billion in damages were brought between 1980 and 1986. Things got so bad that Congress acted to shield vaccine manufacturers from liability in order to ensure sufficient availability of vaccines. There’s no reason to bel...