The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment, the company said on Wednesday.

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...

A Mayo Clinic study confirmed the accuracy of a new FDA-approved blood test for early detection of Alzheimer's disease.

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

Savara faces an FDA setback for Molbreevi, its aPAP treatment. Learn how the company plans to recover and file a new BLA by ...

Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the ...

This latest approval builds on an earlier liquid formulation of generic methimazole for feline hyperthyroidism, which ...

Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

Vusolimogene oderparepvec is a genetically modified herpes simplex type 1 virus designed to directly destroy tumors and generate an anti-tumor immune response.

Shares fell 75% to $3.04, putting the stock on track for a record closing low, according to Dow Jones Market Data. The stock ...

The FDA’s decision to reject Replimune’s (NASDAQ:REPL) lead asset RP1 for a type of skin cancer known as melanoma appears to ...