All this data builds Jefferies’ argument: the FDA change could help boost return on investment and therefore drive R&D spend.

The outside advisors analyzed the results of the RELIEVE-HF pivotal trial, which randomized 508 patients to either receive ...

Encoded Therapeutics has linked its Dravet syndrome gene therapy ETX101 to a 78% reduction in seizures, keeping the biotech ...

The industry’s mRNA alliance is demanding steady FDA leadership, warning that the current “unprecedented turmoil” at the ...

Natera is looking to grow its portfolio of tools to detect the recurrence of cancer with a deal to acquire Foresight ...

Freenome is taking itself public via a special purpose acquisition company, also known as a SPAC deal, to help raise funds in ...

“SCN2A and SCN8A DEEs are devastating conditions with extremely high mortality due to the debilitating seizure burden they ...

Pfizer’s VC arm has backed a $100 million series A raise for OTR Therapeutics, as the Chinese biotech tacks on preclinical ...

Welcome to this week's Chutes & Ladders, our roundup of significant leadership hirings, firings and retirings across the ...

Triana Biomedicines has tapped Pfizer Ventures and a number of other existing and new investors to secure a $120 million ...

The FDA has placed a hold on Denali Therapeutics’ plans to launch a phase 1 rare disease trial, citing concerns about immune ...

The FDA has named Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research, continuing ...