The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new ...

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the ...

In late May, a patient died after receiving Rocket Pharmaceuticals' investigational gene therapy for Danon disease, spurring ...

Regulations aiming to lower the cost of vital medicines will instead end up restricting access and disincentivizing R&D.

VantAI will use its machine learning capabilities to identify novel target-effector pairs that Halda can use in designing its ...

With its structural changes, CSL expects to generate $500 to $550 million in annualized savings over the next three years.

The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can ...

A draft copy of an upcoming MAHA report reveals a strategy in lockstep with recent HHS actions such as reviving the Task ...

Drugs are being invented and manufactured right here in the U.S. by Americans, for Americans. So why doesn’t the industry ...

Media coverage can help biopharma executives connect with, inform and inspire the public. In this column, ...

The Trump administration's ever-changing tariffs and Most Favored Nation drug pricing are part of a blizzard of unclear, ...

While the 10-fold increase in dose over injectable Wegovy has raised questions about the launch, Novo Nordisk has assured ...