ADVERTISEMENT
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, PhD | Jul 14, 2022 | 3 min read
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 | 2 min read
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 | 1 min read
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 | 2 min read
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 | 3 min read
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 | 2 min read
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 | 2 min read
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 | 7 min read
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 | 3 min read
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 | 4 min read
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 | 9 min read
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 | 8 min read
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 | 2 min read
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 | 5 min read
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 | 9 min read
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 | 2 min read
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 | 4 min read
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 | 2 min read
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 | 1 min read
The treatment, Trikafta, increases lung function in most patients with the disease—but comes with a hefty price tag.
ADVERTISEMENT