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.

drug development, FDA
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.
Immunotherapy More Effective in Men: Study
Immunotherapy More Effective in Men: Study
Kerry Grens | May 18, 2018
Women with metastatic cancer who were treated with a checkpoint inhibitor had a smaller benefit than did men.
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.
Patient Registries to Bolster Cell- and Gene-Therapy Clinical Trial Data
Patient Registries to Bolster Cell- and Gene-Therapy Clinical Trial Data
Anna Azvolinsky | May 15, 2018
As the first personalized cell and gene therapies are approved from small clinical trials, researchers propose the creation of publicly accessible databases to pull together real-world results.  
Researchers Develop a Drug Against the Common Cold
Researchers Develop a Drug Against the Common Cold
Catherine Offord | May 15, 2018
In an in vitro study, the compound completely blocked the replication of rhinoviruses.
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.