Imlifidase, an IgG-destroying enzyme, could receive FDA approval in the second half of 2026 and hit peak sales of $306 ...

Arguably the most well-known SERD is AstraZeneca’s Faslodex, which was approved in 2002 for breast cancer and is administered ...

Companies that have broken ground on or are actively constructing manufacturing facilities in the U.S. are exempted from the ...

Though details remain scant, the pending order is expected to be the latest effort in President Donald Trump's campaign to ...

The regulatory greenlight was backed by two Phase III trials that showed normalized growth hormone levels in patients with ...

Truist analysts called the results "encouraging" while pointing out certain unknowns in the data. Immuneering plans to kick ...

Three draft recommendation documents published on Wednesday are intended to guide drug sponsors and accelerate the ...

The decision to stop the Phase IIb study was driven by “strategic business reasons,” according to a federal clinical trials ...

While Harmony management has not disclosed future plans for ZYN002, Jefferies analysts expect the asset to be shelved.

The FDA has issued a warning letter to Johnson & Johnson’s subsidiary Janssen Vaccines, flagging lapses in quality control ...

Acadia Pharmaceuticals was testing the drug, an intranasal formulation of the oxytocin analogue carbetocin, for its potential ...

The regulatory action marks the second rejection for a spinal muscular atrophy therapy this week after Scholar Rock’s ...