approvals

Health Canada has given the single COVID-19 shot the official greenlight for use in people 18 and older.

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.

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

Oligomannate, derived from a compound in seaweed, suppresses neural inflammation caused by gut bacteria in mice.

The US Food and Drug Administration green lights a therapy for an extreme form of multidrug resistant TB.

While farmers have the green light to grow the genetically engineered plant, FDA approval is still needed before the seeds are sold as food.

Scientists have engineered swine that pollute less, fend off disease, and produce more meat, but you won’t find them outside experimental farms . . . yet.

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

Rather, the breast cancer mutation screen was classified as a type of medical device with obligations for the company to reduce risks to customers.

The agency gave personal genomics company 23andMe the green light to screen samples for breast cancer–related genetic mutations.

The diagnostic measures two proteins indicative of brain injury.

Crops produced using mutagenic technologies such as CRISPR should generally be exempt from regulatory laws governing GMOs, according to the published opinion.

More than 200 people are on waiting lists for the $373,000 treatment as hospitals try to work around problems with insurers. 

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.

Tissue recipients were treated as “guinea pigs,” says investigation leader.

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.

A report finds that new medications still take about 12 years to go from patent to patient.

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.

The US Food and Drug Administration greenlights a rare-disease drug that is produced in the eggs of genetically modified chickens.