FDA approves first RSV vaccine
Drug makers have been racing at a breakneck pace to develop respiratory syncytial virus (RSV) vaccines this year. On May 3, the U.S. Food …
Drug makers have been racing at a breakneck pace to develop respiratory syncytial virus (RSV) vaccines this year. On May 3, the U.S. Food …
On April 26, the U.S. Food and Drug Administration (FDA) approved the first investigational microbiome therapeutic for treating recurrent Clostridioides difficile infection in adults. …
FDA approves first microbiome therapeutic for C. diff infection in adults Read More »
On Friday, U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, ordered a hold on federal approval of mifepristone, a drug approved by the U.S. …
Texas mifepristone ruling undermines FDA approval process, experts say Read More »
While animal activists oppose animal testing on moral grounds, the biotech industry knows that alternative technology can provide more accurate and less expensive screening …
Biotech wants to reduce animal testing and FDA is now tasked with helping Read More »
On Friday, March 10, 2023, the United States Food and Drug Administration (FDA) approved Acadia Pharmaceuticals’ drug for genetic Rett syndrome, the company announced …
FDA approves Acadia’s DAYBUE for the treatment of Rett syndrome Read More »
On Feb. 28, 2023, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended approval for Pfizer’s respiratory …
The Pfizer RSV vaccine candidate for adults over 60 has been recommended by an advisory committee of the Food and Drug Administration (FDA), and …
FDA panel recommends Pfizer RSV vaccine for older adults Read More »
To simplify and streamline the COVID-19 vaccination process while pushing for increased vaccination rates, the U.S. Food and Drug Administration (FDA) proposed updating the …
Despite the fact the United States is still dealing with the COVID-19 pandemic, the Center for Drug Evaluation and Research (CDER) of the U.S. …
FDA approved 37 ‘novel’ drugs in 2022, says new analysis Read More »
The U.S. Food and Drug Administration (FDA) on Friday granted accelerated approval for the Alzheimer’s drug LEQEMBI (lecanemab-irmb). The drug is developed by two biotech …
FDA grants accelerated approval for Eisai’s new Alzheimer’s drug Read More »