The drugs have soared in popularity, with some men taking them for unapproved uses like anti-aging or increasing muscle mass.

The decision broadens Jaypirca’s label and converts the December 2023 accelerated approval to a traditional approval status.

The U.S. Food and Drug Administration has approved an expanded indication for Jaypirca (pirtobrutinib), the first and only noncovalent Bruton tyrosine kinase (BTK) inhibitor for adults with relapsed ...

The FDA has approved pirtobrutinib for certain adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.The new indication applies to adults who previously have ...

In small case series, three patients had complete responses and two had partial responses ...

Jaypirca was approved for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were previously treated with a covalent Bruton ...

Pirtobrutinib is now FDA-approved for relapsed/refractory CLL/SLL after prior covalent BTK inhibitor therapy, following its 2023 accelerated approval. The BRUIN-CLL-321 trial showed pirtobrutinib ...

On November 19, 2025, the Food and Drug Administration granted accelerated approval to Bayer’s (BAYRY) sevabertinib, a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous ...

Bristol Myers Squibb BMY recently obtained FDA approval for the label expansion of Breyanzi (lisocabtagene maraleucel) for ...

Discover why Structure Therapeutics Inc. is rated Strong Buy after positive Aleniglipron phase 2b obesity data. Click for ...

The U.S. Food and Drug Administration (FDA) has been rocked by recent changes to several leadership roles while it has ...

Some experts cited the case of Slentrol, an older weight loss drug for dogs made by Pfizer’s animal health division (which ...