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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
A lackluster performance in clinical trials of the monoclonal antibody aducanumab has left some experts unconvinced of its benefit.
Biogen’s Alzheimer’s Drug Gets FDA Approval, Mixed Reviews
Biogen’s Alzheimer’s Drug Gets FDA Approval, Mixed Reviews

A lackluster performance in clinical trials of the monoclonal antibody aducanumab has left some experts unconvinced of its benefit.

A lackluster performance in clinical trials of the monoclonal antibody aducanumab has left some experts unconvinced of its benefit.

FDA, disease & medicine

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 | 2 min read
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 and Christina Brennan | Dec 1, 2020 | 4 min read
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.
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.
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 | 2 min read
Vaccine experts divided on whether that level of protection is too low or too demanding.
FDA Pulls Emergency Use Authorization for Antimalarial Drugs
Amanda Heidt | Jun 16, 2020 | 2 min read
Hydroxychloroquine and chloroquine, once thought to be promising COVID-19 treatments, come with serious heart risks.
False Negatives in Quick COVID-19 Test Near 15 Percent: Study
Lisa Winter | Apr 21, 2020 | 3 min read
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.
CDC Lab Contamination Delayed Coronavirus Testing
Ashley Yeager | Apr 20, 2020 | 2 min read
Assembling the first COVID-19 test kits in the same room as coronavirus material, along with other practices that didn’t follow protocol, made the tests unusable, officials say.
Remdesivir Works Against Coronaviruses in the Lab
Abby Olena, PhD | Mar 20, 2020 | 4 min read
The antiviral disables RNA replication machinery in MERS and SARS viruses. Can it beat back SARS-CoV-2?
vials in a test kit
Test for Novel Coronavirus Approved for Wide Deployment
Shawna Williams | Feb 6, 2020 | 2 min read
The US Food and Drug Administration authorizes the distribution of the 2019-nCoV diagnostic to state health departments and other facilities.
FDA Approves Previously Rejected Muscular Dystrophy Treatment
Emily Makowski | Dec 13, 2019 | 1 min read
The drug Vyondys 53 has met a surrogate endpoint of protein production, but there’s no clear proof it has a clinical benefit.
Ebola Vaccine Approved for Use in Europe
Jef Akst | Nov 11, 2019 | 1 min read
Merck’s Ervebo gets its first regulatory greenlight. A decision from the US Food and Drug Administration is expected in the next few months.
Trump Picks Cancer Researcher Stephen Hahn for FDA Commissioner
Emily Makowski | Nov 4, 2019 | 2 min read
The radiation oncologist and chief medical executive at MD Anderson Cancer Center has not worked in government previously.
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.
The Cerebellum’s Secrets: A Profile of Kamran Khodakhah
Anna Azvolinsky | Oct 1, 2019 | 8 min read
The Albert Einstein College of Medicine neuroscientist has revealed surprising functions of the brain region, such as its role in the brain’s rewards circuits and in addiction.
First New Tuberculosis Drug Approved in 50 Years
Jef Akst | Aug 15, 2019 | 2 min read
The US Food and Drug Administration green lights a therapy for an extreme form of multidrug resistant TB.
gene therapy approval used manipulated data
Some Data Backing Novartis Gene-Therapy Approval Manipulated: FDA
Nicoletta Lanese | Aug 7, 2019 | 2 min read
The agency is now evaluating the implications of the corrupted data behind Zolgensma and whether to “take action” against the pharmaceutical company.
Survey of Stem Cell Clinics Reveals Cause for Concern
Jef Akst | Aug 1, 2019 | 4 min read
Two coauthors of a new study discuss their findings about nearly 170 facilities in the southwestern US selling unproven therapies—and what should be done about them.
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