ADVERTISEMENT
ADVERTISEMENT
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.
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.
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.
FDA Cracks Down on Purveyors of Stem Cell Treatments
Ashley P. Taylor | Dec 21, 2018 | 3 min read
The agency cites safety concerns with customers of Genetech who reported getting E. coli infections and sends letters to other stem cell companies reminding them to follow the rules.
Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy
John D. Loike and Jennifer Miller | Feb 1, 2017 | 4 min read
What can be done to lower development costs and drug prices?
Q&A: From FDA to Industry
Kerry Grens | Sep 27, 2016 | 5 min read
Among a subset of US Food and Drug Administration regulators who leave the agency, more than half go to work for pharmaceutical companies, researchers report.
FDA Reduces Paperwork for “Compassionate Use”
Jef Akst | Jun 8, 2016 | 1 min read
The change should allow patients with fatal illnesses easier access to experimental drugs, but gaining permission from drug companies remains the biggest challenge.
Picking Up the Pace
Kate Yandell | Jan 1, 2016 | 10 min read
FDA designations promise to expedite the approval of drugs for conditions ranging from infectious disease to cancer.
Fatal-Disease Drug in Limbo
Jef Akst | Nov 25, 2015 | 2 min read
A panel of experts advised the US Food and Drug Administration that BioMarin Pharmaceutical has not demonstrated efficacy of its new drug for Duchenne muscular dystrophy.
Battling the Bulge
Bob Grant | Nov 1, 2015 | 6 min read
Weight-loss drugs that target newly characterized obesity-related receptors and pathways could finally offer truly effective fat control.
TS Picks: September 8, 2015
Jef Akst | Sep 8, 2015 | 1 min read
Pharma edition
FDA Approves 3-D–Printed Drug
Jef Akst | Aug 4, 2015 | 1 min read
The US Food and Drug Administration green lights the first medicine produced by a 3-D printer for use in the human body.
FDA Calls for Data on ALS Drug
Jef Akst | Apr 21, 2015 | 2 min read
In the midst of a debate about an experimental drug’s early approval, the US Food and Drug Administration requests that full trial results be released.
ALS Drug Access Debated
Jef Akst | Apr 7, 2015 | 2 min read
Biotech company Genervon has requested accelerated approval for its experimental ALS drug after a small but promising Phase 2 trial. Patients advocate for its acceptance, while researchers urge caution.
Lazarus Drugs
Kate Yandell | Feb 1, 2015 | 8 min read
While some drugs sail through development, others suffer setbacks, including FDA rejections, before reaching the market.
 
That Loving Feeling
Megan Scudellari | Jul 1, 2014 | 9 min read
There are no FDA-approved drugs to treat low sexual desire in women, but not for lack of trying.
Inconsistent Evidence
Jef Akst | Jan 22, 2014 | 1 min read
More than a third of US drug approvals are based on a single large clinical trial, while others require more in-depth study, according to a new report.
Drug Approvals Up
Dan Cossins | Dec 7, 2012 | 1 min read
The total number of new drugs approved this year ties last year for the highest since 2004, suggesting that the pharmaceutical industry is recovering.
 
Hurry Up, FDA
Jef Akst | Dec 6, 2012 | 2 min read
The US Food and Drug Administration is taking steps to get new devices on the market sooner—and antibiotics may be next.
ADVERTISEMENT