Bluebird bio had expected to submit a BLA for its sickle cell disease gene therapy lovotibeglogene autotemcel, or lovo-cel, by Friday. Now, that deadline is getting punted for at least ...

The next generation of Operation Warp Speed is coming soon, and this time it's going to take aim at rare diseases, Peter Marks, the director of the FDA's Center for ...

The FDA is hoping its latest solution will stave off the continued shortage of cisplatin, a key drug used in treating several types of cancer. Beginning ...

B Capital, an investment firm co-founded by Eduardo Saverin of Facebook fame, has closed its inaugural healthcare fund. Add that to its capital growth fund, and B Capital says it ...

Small molecule biotech Totus Medicines has closed a $66 million Series B to carry its PI3Kα inhibitor through Phase Ia and has named Nassim Usman as its new president and ...

To help meet the heightened demand for its injectable products, Eli Lilly is acquiring a facility from Nexus Pharmaceuticals, with production anticipated to start at the end of next year ...

The FDA recently added a new warning and precaution to the label of Horizon's blockbuster monoclonal antibody Tepezza (teprotumumab-trbw), which is used as a treatment for thyroid eye disease, to ...

Below are notable updates from the American Academy of Dermatology’s annual meeting over the weekend: Sanofi amends trial protocol Sanofi has big plans for amlitelimab, the monoclonal antibody ...

Pfizer and Astellas are gunning to add a fourth indication to their cancer drug Xtandi with Phase III trial results released today. The study, looking at ...

Hand­ful of biotechs ex­pect­ed to IPO this fall, but many are stuck in ‘hold­ing pat­tern’ un­til 2024 ...

The US government is setting more goals around biomanufacturing efforts, with a vision for stronger supply chains and greater domestic production. A 64-page report released by ...

Reps. Kelly Armstrong (R-ND) and Ben Cline (R-VA) sent a letter last week to Attorney General Merrick Garland, asking why the Department of Justice is willing to incur potential patent ...