An FDA advisory committee will consider whether PD-L1 expression cutoffs should guide use of checkpoint inhibitors to treat ...

The FDA reached a significant milestone when it approved its reorganization and created its new unified Human Foods Program ...

The Oncologic Drugs Advisory Committee (ODAC) decided 10-2 with one abstention that PD-1 inhibitors do not have a favorable ...

Certain lots of Answers dog food and Darwin's Natural Pet Products, which includes dog and cat food, have been recalled after ...

Pet owners are advised to throw away the at-risk products safely, so pets and children can't access and ingest them ...

The withdrawal comes after postmarketing studies showed that the risks of side effects were greater than the benefits.

The recall involves updating instructions for use, rather than removing devices from where they are used and sold ...

Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced ...

Bristol Myers obtained the drug Cobenfy, also known as KarXT, through its $14 billion takeover of Karuna Therapeutics last ...

The FDA has approved osimertinib (Tagrisso) for locally advanced, unresectable stage III non-small cell lung cancer (NSCLC) ...

"It would be manifestly inefficient to re-direct resources" to CBER "because performing disclosure reviews is a specialized skill that requires training and expertise that most FDA staff do not have," ...