The decision comes more than a year after disappointing initial Phase 3 results and casts further doubt on a class of ...

A massive overhaul of staffing and review processes have left the agency appearing heavily driven by the Trump administration ...

The deal, which involves up to 8 “next-generation” weight loss medications and could be worth more than $18 billion, ranks as ...

AstraZeneca’s investment will “span the value chain” of drug research and development and comes amid a prolonged surge in ...

On a conference call, executives cited “confusion” and declining vaccination rates in the U.S. while discussing a quarterly ...

The biotech also raised $235 million in debt and equity funding to support marketing of the drop, which it claims to be an ...

Still, the medications in the latest round of negotiations — which now includes “Part B” drugs given in doctors offices — ...

Fresh data from multiple studies suggest the drug, which Sanofi has billed as a future blockbuster, could be cleared in the U ...

A spike in M&A activity and stock prices have pulled biotech out of a yearslong downturn. But regulatory tumult and fierce ...

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change ...

A drug Roche acquired in a multibillion-dollar deal could be as effective as Zepbound, but may struggle to stand out in a ...

On a Monday conference call, Sarepta CEO Doug Ingram said new long-term data should help “rebalance the discussion” ...