Brick building with tall windows and letters in front that say "Food and Drug Administration"
FDA Limits Use of J&J Vaccine, Citing Safety Concerns
US adults are now only eligible for the vaccine under certain circumstances.
ABOVE: © iStock.com, Grandbrothers
FDA Limits Use of J&J Vaccine, Citing Safety Concerns
FDA Limits Use of J&J Vaccine, Citing Safety Concerns

US adults are now only eligible for the vaccine under certain circumstances.

US adults are now only eligible for the vaccine under certain circumstances.

ABOVE: © iStock.com, Grandbrothers

FDA

Magnifying glass in front of a stack of files of papers
PLOS ONE Pulls Five Papers Tied to Alzheimer’s Drug Controversy
Jef Akst | Mar 31, 2022
The retracted studies were coauthored by a scientist who worked on an Alzheimer’s therapy in development by Cassava Sciences, a company reportedly under investigation for providing falsified data to the FDA.
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.
istock
AI Helps Predict Winners and Losers in Clinical Trials
Roni Dengler, PhD | Aug 3, 2021
Pradipta Ghosh has plans to revolutionize the drug discovery pipeline.
headshot man
Ophthamologist Alan Scott Dies at Age 89
Chloe Tenn | Dec 29, 2021
The Smith-Kettlewell Eye Research Institute scientist developed Botox for medicinal use.
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.
plasma bags hospital
WHO Rejects Convalescent Plasma Treatment for COVID-19
Chloe Tenn | Dec 6, 2021
Current evidence suggests the treatment does not improve survival or reduce the need for ventilation in COVID-19 patients, the World Health Organization says.
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
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.
a pill bottle with dice spilling out
Book Excerpt from You Bet Your Life
Paul A. Offit | Sep 21, 2021
In his book’s Introduction, physician-scientist Paul A. Offit reviews the unusual constellation of circumstances around the development of COVID-19 vaccines.
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.
An artistic rendering of blue neurons against a white background
Participant’s Diagnosis Halts Gene Therapy Clinical Trial
Amanda Heidt | Aug 12, 2021
The FDA pauses the research program on a lentivirus-based treatment for a rare neurological condition after a patient developed a bone marrow disorder that could presage leukemia.
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.
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.
COVID-19, SARS-CoV-2, Johnson & Johnson, Pfizer, Moderna, vaccine, vaccination, variant, FDA
US Authorizes a Third COVID-19 Vaccine
Asher Jones | Mar 1, 2021
Johnson & Johnson’s one-shot immunization could reach people’s arms as early as March 2.
Opinion: Emergency Use Authorizations Are a Threat to Science 
Kevin J. Tracey, 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.