Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

Replimune Group Inc. shares sank to their lowest point ever after US regulators rejected a skin cancer treatment from the ...

While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

WuXi Biologics secures US FDA Pre-License Inspection approval for five facilities, first for commercial PFS line: Wuxi, China Wednesday, July 23, 2025, 13:00 Hrs [IST] WuXi Biolog ...

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

The US Food and Drug Administration (FDA) embraced the use of biomarkers and surrogate endpoints in its most recent guidance on developing therapeutics for early Alzheimer's disease (AD). The ...

On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory ...