Biogen Defends Newly Approved Alzheimer’s Drug
Biogen Defends Newly Approved Alzheimer’s Drug
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.
Biogen Defends Newly Approved Alzheimer’s Drug
Biogen Defends Newly Approved Alzheimer’s Drug

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.

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.

FDA
Updated
Biogen’s Alzheimer’s Drug Gets FDA Approval, Mixed Reviews
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
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.
US Authorizes a Third COVID-19 Vaccine
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<strong>&nbsp;</strong>
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.
Concerns over Efficacy and Cost of Muscle Wasting Treatments
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
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.
Doctors Forge Ahead with Plasma for COVID-19, Benefits Uncertain
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
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.
FDA to Require 50 Percent Efficacy for COVID-19 Vaccines
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.
FDA Pulls Emergency Use Authorization for Antimalarial Drugs
FDA Pulls Emergency Use Authorization for Antimalarial Drugs
Amanda Heidt | Jun 16, 2020
Hydroxychloroquine and chloroquine, once thought to be promising COVID-19 treatments, come with serious heart risks.
Neurobiologist and Former Stanford President Donald Kennedy Dies
Neurobiologist and Former Stanford President Donald Kennedy Dies
Amy Schleunes | Apr 23, 2020
Kennedy, who succumbed to COVID-19, served as commissioner of the FDA and editor-in-chief of Science, and is credited with helping to transform Stanford into a top research university.
False Negatives in Quick COVID-19 Test Near 15 Percent: Study
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.
CDC Lab Contamination Delayed Coronavirus Testing
CDC Lab Contamination Delayed Coronavirus Testing
Ashley Yeager | Apr 20, 2020
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.
First Saliva Test for COVID-19 Approved for Emergency Use by FDA
First Saliva Test for COVID-19 Approved for Emergency Use by FDA
Lisa Winter | Apr 14, 2020
The search for SARS-CoV-2 RNA in 60 saliva samples yielded the same results as conventional nasal swab tests taken from the same patients.
Remdesivir Works Against Coronaviruses in the Lab
Remdesivir Works Against Coronaviruses in the Lab
Abby Olena | Mar 20, 2020
The antiviral disables RNA replication machinery in MERS and SARS viruses. Can it beat back SARS-CoV-2?
Judge Rules Unreported Clinical Trial Data Must Be Made Public
Judge Rules Unreported Clinical Trial Data Must Be Made Public
Amy Schleunes | Feb 26, 2020
The sponsors of upwards of 1,000 clinical trials may be forced to publish data that have gone unpublished over a 10-year period.
FDA Now Allows Certain Lab Animals to Be Retired and Adopted
FDA Now Allows Certain Lab Animals to Be Retired and Adopted
Lisa Winter | Feb 11, 2020
Current bills in Congress would apply similar provisions to all federal agencies.
Test for Novel Coronavirus Approved for Wide Deployment
Test for Novel Coronavirus Approved for Wide Deployment
Shawna Williams | Feb 6, 2020
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
FDA Approves Previously Rejected Muscular Dystrophy Treatment
Emily Makowski | Dec 13, 2019
The drug Vyondys 53 has met a surrogate endpoint of protein production, but there’s no clear proof it has a clinical benefit.