Monday after the biotechnology company disclosed disappointing drug-trial data, which could lengthen the timeline of the ...

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 ...

Developers of biosimilars, medicines that are near-identical copies of biologic drugs, will no longer be required to conduct clinical trials to prove effectiveness.

FDA announces major reforms to streamline biosimilar approvals, potentially saving Americans billions on prescription drug ...

The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and ...

Progress has been made in identifying and treating the disease, but the impact of federal cuts is yet to be borne out.

Day Safety Update Submitted to FDA ORCA-OL Long-Term Safety Trial Successfully ConcludedDSMC Completes Final Review of Cytisinicline, Finds No Drug Safety Concerns SEATTLE and VANCOUVER, British ...

Chiesi Global Rare Diseases, a business unit of the Chiesi Group, and Protalix BioTherapeutics, Inc. (NYSE American: PLX), have requested a re-examination of the recent negative opinion issued by the ...

President Donald Trump says he's "on it" after "Dilbert" cartoonist Scott Adams asked for help amid his battle with cancer.

This article compares the global pharmacovigilance standards with the practices followed in Saudi Arabia. It highlights similarities, differences, and areas where the Kingdom has made progress or ...

- Duchenne (SGT-003): 23 participants have been dosed in the INSPIRE DUCHENNE trial as of October 31, 2025; Solid expects to ...

There are a number of considerations that can help streamline the pathway to the clinic. One of the first is which vector system will be used, with AAV and lentivirus being two of the most commonly ...