regulatory approval

News

FDA clears BMS’ Breyanzi for follicular lymphoma

Bristol-Myers Squibb has chalked up another FDA approval for its CD19-directed CAR-T therapy Breyanzi, this time as a third-line or later therapy for follicular lymphoma (

News

X4 Pharma gets first FDA okay for WHIM syndrome drug

Patients in the US with the ultra-rare disease WHIM syndrome now have their first approved treatment, after X4 Pharma’s Xolremdi was given a green light by the FDA.

News

Pfizer offers warranty for new haemophilia B therapy Beqvez

Pfizer has said it will launch its just-approved haemophilia B gene therapy Beqvez with a warranty programme that will provide “greater certainty” to payers, after setting

News

EU OK sets up first ex-China launches for BeiGene's Tevimbra

BeiGene has claimed a second EU approval for PD-1 inhibitor tislelizumab in non-small cell lung cancer (NSCLC), opening the door to the first launches of the drug outside

News

FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

After rejecting ImmunityBio’s Anktiva last year, the FDA has cleared the drug as a treatment for bladder cancer, making it the company’s first commercial-stage product.

News