Tag: FDA
Why Novavax’s path to survival won’t be easy
Medical syringes and Novavax logo displayed in the background are seen in this illustration photo taken in Krakow, Poland on December 2, 2021.Jakub Po [...]
New Covid vaccines in fall need to target XBB variants, FDA staff says
Syringe with Covid-19 vaccine against the XBB Variant. Fight against virus Covid-19 Coronavirus, Vaccination and immunization.Undefined Undefined | Is [...]
FDA advisors OK AstraZeneca, Sanofi antibody for infants for RSV
Narisara Nami | Moment | Getty ImagesA panel of independent advisors to the Food and Drug Administration unanimously recommended Thursday that the ant [...]
FDA allows import of unapproved China chemo med
Worker labors on a production line at factory of Qilu Pharmaceutical (Hainan) Co Ltd on February 11, 2022 in Haikou, Hainan Province of China.Su Bikun [...]
Neuralink gets FDA approval for ‘in-human’ trials of its brain-computer interface
Elon Musk’s brain-computer interface startup, Neuralink, reportedly received approval from the United States Food and Drug Administration (FDA) to con [...]
FDA approves Pfizer Covid drug for high-risk adults
The Food and Drug Administration on Thursday granted full approval to Pfizer's Covid antiviral pill, Paxlovid, for adults who are at high risk of gett [...]
Pfizer RSV shot for infants has favorable safety data, FDA staff say
Blood sample for respiratory syncytial virus (RSV) testJarun011 | Istock | Getty ImagesU.S. Food and Drug Administration staff on Tuesday said Pfizer' [...]
FDA approves GSK shot for older adults
A GSK lab in London.Oli Scarff | Getty ImagesThe Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use [...]
FDA grants accelerated approval for Biogen ALS drug
A pedestrian walks past Biogen Inc. headquarters in Cambridge, Massachusetts, on Monday, June 7, 2021.Adam Glanzman | Bloomberg | Getty ImagesThe Food [...]
Texas Judge Invalidates FDA Approval of the Abortion Pill Mifepristone
The Texas judge’s ruling was quickly contradicted by another federal judge in Washington State who ordered the F.D.A. to keep mifepristone available.
[...]
FDA to Allow a Second Updated Covid Booster for Seniors and the Immunocompromised
Federal regulators plan to authorize an additional dose for seniors and immunocompromised people in the coming weeks, ahead of the introduction of a n [...]
Lecanemab, a new Alzheimer’s drug, could soon get FDA approval. Does it actually work?
A new Alzheimer’s medication appears to be on the verge of approval by the US Food and Drug Administration. But such a major milestone, given the p [...]
FDA pulls antibody bebtelovimab because not effective against omicron BQ.1
An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021.Mike Segar | Reut [...]
FDA says two studies showing omicron boosters weren’t much better than old shots were too small to come to any conclusions
The Food and Drug Administration said two studies this week showing that the new omicron boosters weren't that much better than the old shots were too [...]
FDA Authorizes Updated Covid Booster Shots For Kids 5 to 11
Regulators authorized the shots for older age groups in late August, but much of the general population appears either unaware or uninterested in them [...]