Ebola Vaccine Approved for Use in Europe
Ebola Vaccine Approved for Use in Europe
Merck’s Ervebo gets its first regulatory greenlight. A decision from the US Food and Drug Administration is expected in the next few months.
Ebola Vaccine Approved for Use in Europe
Ebola Vaccine Approved for Use in Europe

Merck’s Ervebo gets its first regulatory greenlight. A decision from the US Food and Drug Administration is expected in the next few months.

Merck’s Ervebo gets its first regulatory greenlight. A decision from the US Food and Drug Administration is expected in the next few months.

approvals
China Approves Alzheimer’s Treatment that Targets the Microbiome
China Approves Alzheimer’s Treatment that Targets the Microbiome
Kerry Grens | Nov 5, 2019
Oligomannate, derived from a compound in seaweed, suppresses neural inflammation caused by gut bacteria in mice.
First New Tuberculosis Drug Approved in 50 Years
First New Tuberculosis Drug Approved in 50 Years
Jef Akst | Aug 15, 2019
The US Food and Drug Administration green lights a therapy for an extreme form of multidrug resistant TB.
USDA Approves Edible Cotton
USDA Approves Edible Cotton
Jef Akst | Oct 29, 2018
While farmers have the green light to grow the genetically engineered plant, FDA approval is still needed before the seeds are sold as food.
The Superpowers of Genetically Modified Pigs
The Superpowers of Genetically Modified Pigs
Kerry Grens | Aug 1, 2018
Scientists have engineered swine that pollute less, fend off disease, and produce more meat, but you won’t find them outside experimental farms . . . yet.
Questions Raised About “Breakthrough” Therapies’ Clinical Support
Questions Raised About “Breakthrough” Therapies’ Clinical Support
Catherine Offord | Jul 17, 2018
Compared to other drugs, therapeutics given breakthrough status receive FDA approval on the basis of weaker trial evidence, a study finds.
Opinion: No, FDA Didn’t Really Approve 23andMe’s <em>BRCA</em> Test
Opinion: No, FDA Didn’t Really Approve 23andMe’s BRCA Test
Cecile Janssens | Mar 19, 2018
Rather, the breast cancer mutation screen was classified as a type of medical device with obligations for the company to reduce risks to customers.
First Direct-to-Consumer BRCA Test Authorized by FDA
First Direct-to-Consumer BRCA Test Authorized by FDA
Kerry Grens | Mar 6, 2018
The agency gave personal genomics company 23andMe the green light to screen samples for breast cancer–related genetic mutations.
First Blood Test for Concussion Approved by FDA
First Blood Test for Concussion Approved by FDA
Kerry Grens | Feb 15, 2018
The diagnostic measures two proteins indicative of brain injury.
EU Advisor Recommends Regulatory Exemption for Gene Editing
EU Advisor Recommends Regulatory Exemption for Gene Editing
Catherine Offord | Jan 18, 2018
Crops produced using mutagenic technologies such as CRISPR should generally be exempt from regulatory laws governing GMOs, according to the published opinion.
Gilead’s CAR T-Cell Therapy Administered to Just Five Patients in Two Months
Gilead’s CAR T-Cell Therapy Administered to Just Five Patients in Two Months
Catherine Offord | Dec 17, 2017
More than 200 people are on waiting lists for the $373,000 treatment as hospitals try to work around problems with insurers. 
Advisors to FDA Recommend Approval of Gene Therapy for Blindness
Advisors to FDA Recommend Approval of Gene Therapy for Blindness
Jef Akst | Oct 12, 2017
Spark Therapeutics’s Luxturna would be the first approved therapy in the U.S. that replaces or repairs a defective gene inherited from one’s parents.
Artificial Tissues Implanted Without Regulatory Approval, Investigation Reports
Artificial Tissues Implanted Without Regulatory Approval, Investigation Reports
Ashley P. Taylor | Oct 3, 2017
Tissue recipients were treated as “guinea pigs,” says investigation leader.
Second-Ever ALS Drug Approved
Second-Ever ALS Drug Approved
Jef Akst | May 8, 2017
Amyotrophic lateral sclerosis patients in the U.S. now have an option besides riluzole, which was approved by the FDA more than two decades ago and only extends life by two or three months.
Drug Approval Timeline Same as 20 Years Ago
Drug Approval Timeline Same as 20 Years Ago
Kerry Grens | Jan 9, 2017
A report finds that new medications still take about 12 years to go from patent to patient.
Planning for the Next Ebola Outbreak
Planning for the Next Ebola Outbreak
Bob Grant | Jan 20, 2016
A public-health nonprofit and an international drugmaker team up to stockpile hundreds of thousands of doses of a promising vaccine and to speed along the approval process.
Drug Produced in GM Chicken Approved
Drug Produced in GM Chicken Approved
Jef Akst | Dec 10, 2015
The US Food and Drug Administration greenlights a rare-disease drug that is produced in the eggs of genetically modified chickens.
Clinical Trial Data Underreported: Study
Clinical Trial Data Underreported: Study
Kerry Grens | Nov 16, 2015
One-third of the human experiments for approved drugs failed transparency requirements.
Doctor Who Blocked Thalidomide Dies
Doctor Who Blocked Thalidomide Dies
Kerry Grens | Aug 11, 2015
Frances Oldham Kelsey, a physician who halted use of a drug that caused birth defects in babies, has passed away at age 101.
FDA OKs Herpes Blood Test
FDA OKs Herpes Blood Test
Kerry Grens | Jul 6, 2015
The US Food and Drug Administration approves Theranos’s fingerstick test for herpes.