The FDA has designated Morphochem’s MCB3837 as a Qualified Infectious Disease Product and simultaneously put the antibiotic on its regulatory fast-track…

The FDA is not happy with Merck’s monoclonal antibody Clostridium difficile candidate and is demanding more data and analyses from its trials before it can…

Initially it looked like a U.S. biotech to be the first; then a team funded by the billionaire co-founder of Napster; now, it looks like it will be Chinese…

Cassiopea has taken control of a Phase II trial after the Israeli biotech it licensed the drug from shut down midstudy, delaying the data readout.

Fresh off a positive FDA panel earlier this month for what could be its first approved biosimilar for Humira, Amgen--and partner Allergan--have reported…

Boston’s Rhythm has produced highly impressive results for its FDA “breakthrough” candidate setmelanotide in people with an ultra-rare genetic disease that…

Gene therapy player AveXis has gotten a Breakthrough Therapy Designation for its only clinical candidate, AVXS-101 to treat spinal muscular atrophy Type 1.

Gene therapy player Audentes Therapeutics priced at the midpoint of its IPO range, raising $75 million, and then proceeded to move up about 10% in early…