Building with sign reading “Novartis”
Two Children Die After Receiving Novartis Gene Therapy
No deaths had previously been associated with the muscle-wasting treatment Zolgensma.
Two Children Die After Receiving Novartis Gene Therapy
Two Children Die After Receiving Novartis Gene Therapy

No deaths had previously been associated with the muscle-wasting treatment Zolgensma.

No deaths had previously been associated with the muscle-wasting treatment Zolgensma.

food and drug administration
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.
US Capitol with Senate building in the foreground
Robert Califf Confirmed to Lead FDA
Shawna Williams | Feb 15, 2022
A narrow Senate vote ends a 13-month period during which the agency has lacked a permanent commissioner.
Several silver foil pill packs with white pills
FDA Authorizes Pfizer’s Paxlovid, First Oral Therapy for COVID-19
Jef Akst | Dec 23, 2021
Given within three days of symptom onset, the pill combination was nearly 90 percent effective at preventing high-risk patients from developing severe illness in a clinical study.
images related to COVID-19 pandemic, including sign reading "please keep your distance," illustration of the virus, various pills, vaccine syringes
What We Learned About COVID-19 in 2021
Shawna Williams | Dec 16, 2021
As Omicron induces a sense of deja vu at the close of the year, we look back at a few key ways in which our understanding has moved forward.
blue and white building sign
Biden Picks Robert Califf to Head the FDA for a Second Time
Chloe Tenn | Nov 12, 2021
The cardiologist was briefly the FDA Commissioner in the Obama Administration, and now has a second chance to act on plans he tried to implement during his first tenure.
gloved hands put a band-aid on the shoulder of a child wearing a mask
CDC Green Lights Pfizer’s Vaccine for Younger Kids
Shawna Williams | Nov 3, 2021
With the final hurdle cleared, the COVID-19 vaccine could be administered to US children ages 5 through 11 as early as today.
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.
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.
two black-and-white microscope images, one with a few black dots, the other with many rod-shaped bacteria
Identifying a Killer, 1895
Catherine Offord | Jul 1, 2021
A contaminated ham put bacteriologist Émile Pierre-Marie van Ermengem on the path to discovering the microbe that produces botulinum toxin.
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.
Pandemic Accelerates Trend Toward Remote Clinical Trials
Jef Akst | May 1, 2021
Now more than ever before, recruiting patients for a research study doesn’t have to mean getting them to leave their homes.
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.
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.
A Challenge Trial for COVID-19 Would Not Be the First of Its Kind
Jef Akst | Oct 8, 2020
Although scientists debate the ethics of deliberately infecting volunteers with SARS-CoV-2, plenty of consenting participants have been exposed to all sorts of pathogens in prior trials.
a bag of plasma ready to be delivered by IV
Doctors Forge Ahead with Plasma for COVID-19, Benefits Uncertain
Shawna Williams | Aug 14, 2020
Researchers say the popularity of convalescent plasma makes it more difficult to gather high-quality data on its efficacy.
Activities Discovered for Some Inactive Drug Ingredients
Ruth Williams | Jul 23, 2020
Screens of hundreds of drug excipients reveal that some can interact with biological targets, contradicting their FDA categorization as inert.
Former FDA Commissioner Frank Young Dies
Jef Akst | Dec 2, 2019
The physician-researcher laid the groundwork for genetic cloning and led the US Food and Drug Administration as the country faced the AIDS crisis in the 1980s.
a photo of the packaging for the drug Trikafta
FDA Approves New Cystic Fibrosis Drug
Shawna Williams | Oct 24, 2019
The treatment, Trikafta, increases lung function in most patients with the disease—but comes with a hefty price tag.