The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

Sarepta’s stock plunged about 38% in after-hours trading, after it closed the regular session up 1.8%. That decline would put ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative ...

The Food and Drug Administration said it will be taking steps to speed up the approval process for developing generic biological drugs, an effort aimed at increasing cheaper competition among ...

WASHINGTON (7News) — Artificial intelligence is poised to dramatically reshape the process of developing and approving new medicines, according to industry experts. Traditionally, the path from drug ...

The Trump administration is proposing changes to Food and Drug Administration guidelines that would make it less expensive ...

Life sciences group Thermo Fisher has sealed an all-cash takeover of drug trial software maker Clario in a deal that values ...

The FDA will move select drugs through the approval process in 1 to 2 months rather than the standard 10 months.

Here in the USA, we have lived with the confidence that the medications sold over the counter, by prescription or ...

The treatment for adult epilepsy patients 'Excoprijeong (Senovamate)' has been approved as the 41st new drug developed in Korea. The Ministry of Food and Drug Safety said the drug is authorized as an ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

The Food and Drug Administration should eliminate its approve/disapprove method of reviewing new drug applications and instead use a Consumer Reports approach that is based on drug ratings, according ...