A joint working group is trying to remove obstacles to clinical research in India.

The EMA has updated its guidance on first-in-human clinical trials in light of a fatality in a French study earlier this year.

Parexel says new software could help biopharma companies meet the looming EMA deadline for adopting Identification of Medicinal Products standards.

The FDA cleared Onkos Surgical’s limb salvage system for the treatment of patients who have suffered bone loss from cancer, trauma or previous surgeries.

Clinical trial transparency is the name of the game with a new site launched this week aimed at allowing everyone to “locate, match, and share all publicly…

After a quiet few months since the equity firm Amulet bought out the company, CRO SynteractHCR has made a series of high-profile appointments to “match global…

After days of rumors that Dr. Ron Farkas, a vocal FDA critic of Sarepta’s Duchenne med eteplirsen, had left the agency, Parexel has confirmed to FierceCRO that…

Parexel, one of the world’s largest CROs, is urgently looking into what it is calling an “incident of misappropriation of corporate funds by an employee” as it…

The FDA is looking into the safety of one treatment from the FAAH inhibitor class after a patient died and 5 were severely injured after taking high doses of a…

Regulatory