Keyword: Food and Drug Administration (FDA)

Nektar Therapeutics created Inheris Biopharma, a new subsidiary that will take over the launch of Nektar’s pain drug, NKTR-181.

Affimed has terminated its bispecific T-cell engager program after the FDA hit it with a clinical hold and shifted ts focus to innate cell engagers.

Scott Gottlieb has slipped right back into his old ways, becoming "special partner" at his old life science VC firm New Enterprise Associates.

The FDA allowed manufacturers to file 1.1 million device reports to a little-known internal database, a Kaiser Health News investigation found.

The once-straightforward definition of a medical device has begun to stretch. And, for that matter, so has the definition of a medical device company.

The FDA warned diabetes patients of the risks of using homegrown treatment devices, such as unrecognized combos of CGMs and insulin pumps.

The FDA has quashed ImmunoGen’s hopes of filing for approval of mirvetuximab soravtansine on the strength of a failed phase 3.

Daiichi Sankyo went one for two in an FDA advisory committee doubleheader Tuesday, with its prospective leukemia treatment getting struck out.

Grail’s multicancer blood test has taken a helpful step closer to approval, by obtaining a breakthrough device designation from the FDA.

Zebra Medical received an FDA go-ahead to use AI to quickly scour X-rays and alert clinicians for signs of pneumothorax.