After announcing it would start selling its assets earlier this year, along with laying off nearly half the company, the ...

Baxter put forward clinical data showing that its expanded hemodialysis approach, which aims to filter out a greater range of ...

Ultragenyx is gearing up to take its glycogen storage disease (GSD) treatment to regulators next year after the gene therapy ...

CAR-T cell therapy has been the darling of the oncology world for more than a decade, where it’s had most success against ...

This story is part 2 in a four-part series about cell therapy created by the Fierce Biotech team. Part 1 is available here.

Immunovant’s decision to prioritize a next-gen FcRn antibody over phase 3 myasthenia gravis (MG) prospect batoclimab means ...

Soterios Pharma is eyeing phase 3 after a 1% dose of the company's alopecia areata cream improved severity of the condition, ...

The new guidance explains that once a sponsor receives an abbreviated new drug application (ANDA), new drug application (NDA) ...

In 2015, after spending nearly four decades grinding his way up the ladder at one of the world’s most prolific construction ...

Johnson & Johnson’s oral add-on drug significantly improved depressive symptoms and sleep outcomes in a phase 3 trial for ...

This story is the first part in a four-part series about cell therapy, created by the Fierce Biotech team. | A Special Report ...

Prothena’s investigational new drug (IND) application for PRX019 was cleared by the FDA in December 2023, and, now, BMS is ...