Praxis’ vormatrigine reduced seizures by 56.3%, an effect size that, according to analysts at Truist Securities, exceeds that ...

While the deaths occurred in patients who had been treated with Agios’ anemia treatment Pyrukynd, the biotech insisted in an ...

In an open letter, 22 experts who designed and ran Replimmune’s Phase III IGNYTE trial answered the FDA’s issues, as outlined ...

The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually ...

From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to ...

Josh Ludwig is global commercial director at ScaleReady, where he leads a team of scientists that drives new business through ...

The company expects that the U.S. COVID-19 vaccination rate will be “maybe a couple of points lower” than the prior level of ...

The pivotal Phase II trial is testing Allogene’s CAR T candidate cemacabtagene ansegedleucel for large B-cell lymphoma.

Earlier this year, the Centers for Medicare and Medicaid Services scrapped a previous proposal, from the Biden administration ...

Strengthening strategic partnerships and expanding client base through North America-Asia manufacturing hubs ■  Targeting ...

Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy ...

A ripple effect of the NIH's slashed 2026 budget will be felt throughout the biopharma ecosystem. Young companies must act ...