ISTOCK, OONAL
Questions Raised About “Breakthrough” Therapies’ Clinical Support
Questions Raised About “Breakthrough” Therapies’ Clinical Support
Compared to other drugs, therapeutics given breakthrough status receive FDA approval on the basis of weaker trial evidence, a study finds.
Questions Raised About “Breakthrough” Therapies’ Clinical Support
Questions Raised About “Breakthrough” Therapies’ Clinical Support

Compared to other drugs, therapeutics given breakthrough status receive FDA approval on the basis of weaker trial evidence, a study finds.

Compared to other drugs, therapeutics given breakthrough status receive FDA approval on the basis of weaker trial evidence, a study finds.

FDA, tuberculosis
Supreme Court Nominee Draws Concern from Environmentalists
Supreme Court Nominee Draws Concern from Environmentalists
Catherine Offord | Jul 10, 2018
President Trump’s pick, Judge Brett Kavanaugh, has often opposed court involvement in environmental and health regulations.
FDA Approves First Marijuana-Derived Drug
FDA Approves First Marijuana-Derived Drug
Shawna Williams | Jun 25, 2018
As the CBD-based medication enters the market, the agency promises a crackdown on producers of cannabidiol products that make unproven claims.
New Treatments for Phenylketonuria Aim to Loosen Reins on Strict Diet
New Treatments for Phenylketonuria Aim to Loosen Reins on Strict Diet
Diana Kwon | May 29, 2018
Biotechs have developed enzyme replacements and genetically modified probiotics to treat patients with the rare metabolic disorder.
Congress Passes “Right to Try” Bill
Congress Passes “Right to Try” Bill
Jim Daley | May 23, 2018
Medical groups have criticized the legislation, which will give terminal patients access to experimental treatments, as dangerous and unnecessary.
FDA Approves Drug to Ease Symptoms of Opioid Withdrawal
FDA Approves Drug to Ease Symptoms of Opioid Withdrawal
Catherine Offord | May 17, 2018
Lucemyra is the first non-opioid drug to be approved in the U.S. specifically for this purpose.
FDA Seeks to Block Two Unregulated Stem Cell Clinics
FDA Seeks to Block Two Unregulated Stem Cell Clinics
Jim Daley | May 11, 2018
Two patients became legally blind after receiving treatments at the facilities.
Texas Stem Cell Law Opens Door for Controversial Treatments
Texas Stem Cell Law Opens Door for Controversial Treatments
Anna Azvolinsky | Mar 27, 2018
The Scientist looks at one such Houston-based purveyor that has been treating patients abroad for years with mesenchymal stem cells.
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.
Recipients of Experimental Herpes Vaccine File Lawsuit
Recipients of Experimental Herpes Vaccine File Lawsuit
Catherine Offord | Mar 15, 2018
The suit claims that Rational Vaccines, the company of recently deceased researcher William Halford, violated US and international laws when it carried out the procedure.