A 3D rendering of a neuron
Independent FDA Advisory Panel Recommends Approving ALS Drug
The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.
Independent FDA Advisory Panel Recommends Approving ALS Drug
Independent FDA Advisory Panel Recommends Approving ALS Drug

The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.

The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.

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Building with sign reading “Novartis”
Two Children Die After Receiving Novartis Gene Therapy
Andy Carstens | Aug 12, 2022
No deaths had previously been associated with the muscle-wasting treatment Zolgensma.
A shipping pallet of vaccines with Novavax's logo on it
FDA Authorizes Novavax COVID-19 Vaccine
Christie Wilcox | Jul 14, 2022
Agency members express hope that the availability of a traditional, protein-based vaccine might convince holdouts to get vaccinated.
Child getting a bandaid put on arm by doctor.
FDA Green Lights COVID-19 Vaccines for Kids Under 5
Andy Carstens | Jun 17, 2022
Moderna and Pfizer-BioNTech shots could be given to the youngest kids as early as June 21.
Human kidney in hands stock photo
Surgeons Successfully Transplant a Pig Kidney into a Person
Chloe Tenn | Oct 20, 2021
The achievement bolsters hopes that nonhuman animals could be used to remedy the shortage of transplantable organs.
Updated
Merck research facility in San Francisco
Antiviral Pill Lowers Risks of COVID-19 Hospitalization, Death
Chloe Tenn | Oct 1, 2021
Merck reports that its antiviral molnupiravir was effective against early stages of COVID-19 in high-risk patients in a Phase 3 clinical trial.
Updated Mar 8
A healthcare worker holds up three syringes with clear medicine
To Booster or Not: Scientists and Regulators Debate
Jef Akst | Sep 16, 2021
President Biden’s planned rollout of additional COVID-19 vaccine doses is set to begin next week, but questions remain about who should get them.
Updated
Photograph of the US Food and Drug Administration’s sign outside their offices in Washington, D.C.
Lawmakers Request Information About Alzheimer’s Drug Approval
Annie Melchor | Sep 3, 2021
The FDA granted the drug, called Aduhelm, accelerated approval earlier this summer in a process that’s since drawn scrutiny.
photograph of a syringe and vial of colorless liquid
FDA Approves Pfizer-BioNTech COVID-19 Vaccine
Annie Melchor | Aug 23, 2021
The milestone marks the first fully-approved COVID-19 vaccine in the United States.
A stamp with a checkmark and the word FDA approved lying on its side on a white background.
Biogen Defends Newly Approved Alzheimer’s Drug
Jef Akst | Jul 27, 2021
The US Food and Drug Administration has called for a federal investigation of its own regulatory review process after widespread criticism of its decision on Aduhelm.
Updated
blue and white sign for the entrance to the FDA that says U.S. Department of Health and Human Services Food and Drug Administration
Biogen’s Alzheimer’s Drug Gets FDA Approval, Mixed Reviews
Kerry Grens | Jun 7, 2021
A lackluster performance in clinical trials of the monoclonal antibody aducanumab has left some experts unconvinced of its benefit.
A person wearing a purple glove holds out a blue pill
Fecal Microbiota Transplantation Is Poised for a Makeover
Shawna Williams | Jun 1, 2021
With multiple microbiota therapeutics in the pipeline for recurrent Clostridium difficile infection, clinicians foresee a shift in treatment options for the condition.
FDA Clears Genetic Modification in Pigs for Biomedicine and Food
Catherine Offord | Dec 15, 2020
The decision, which concerns the removal of a sugar molecule on the surface of cells in a line of domestic pigs, marks the first time an approval has been granted for both purposes simultaneously.
Opinion: Emergency Use Authorizations Are a Threat to Science 
Kevin J. Tracey and Christina Brennan | Dec 1, 2020
As COVID-19 therapies get emergency-use green lights, the Biden administration must organize a therapeutic review board to help identify what’s working and what’s not.
Concerns over Efficacy and Cost of Muscle Wasting Treatments
Ruth Williams | Nov 11, 2020
Two new medications for treating a rare and deadly neuromuscular disease have high prices and questionable efficacies, say scientists.
blood, plasma, COVID-19, SARS-CoV-2, pandemic, coronavirus, FDA, Food and Drug Administration, emergency use authorization, EUA, treatment
FDA Gives Plasma Go-Ahead to Treat COVID-19, Experts Skeptical
Amanda Heidt | Aug 24, 2020
White House officials hail convalescent plasma as a major breakthrough, but scientists say evidence supporting its effectiveness is still lacking.
covid-19, pandemic, SARS-CoV-2, coronavirus, vaccine, fauci, FDA, medicine, vaccine development
FDA to Require 50 Percent Efficacy for COVID-19 Vaccines
Amanda Heidt | Jul 1, 2020
Vaccine experts divided on whether that level of protection is too low or too demanding.
False Negatives in Quick COVID-19 Test Near 15 Percent: Study
Lisa Winter | Apr 21, 2020
Abbott’s ID NOW test missed the most positive samples among five products given the green light by the FDA to use during the pandemic.