Topic:

Regulatory

Latest Headlines

Latest Headlines

Delcath axes one-third of staff after FDA rejection

Delcath's year of disappointment lumbers on as the New York company axes 21 of its 60 employees, looking to cut costs as it figures out just what to do with an FDA-rejected device.

SCOTUS sides with Edwards in Medtronic patent feud

The Supreme Court has rejected Medtronic's effort to overturn a heart valve patent loss, meaning Edwards Lifesciences gets to keep its U.S. market dominance and an $83.6 million award.

Delcath axes one-third of staff after FDA rejection

Delcath's year of disappointment lumbers on as the New York company has canned 21 of its 60 employees, looking to cut costs as it figures out just what to do with an FDA-rejected device.

FDA: Medtronic, CardioMEMS panel reviews are on despite government shutdown

Despite the government shutdown, Medtronic and CardioMEMS will proceed with key FDA meetings scheduled for this week intended to advance approval processes for their medical devices, the agency confirmed.

Atossa pulls breast cancer Dx after FDA challenges regulatory status

Atossa Genetics is voluntarily recalling its signature breast cancer test and related products from the market to address the FDA's allegations that they lacked clearance for their promoted uses. 

Pfizer, Ligand snag FDA approval for hot flash drug

Government shutdown or no, the FDA kept its PDUFA word for Pfizer and Ligand's treatment for hot flashes, approving a long-delayed drug that'll enter the crowded market for hormone therapies.

GSK, Genmab seek first-line CLL use of Arzerra in EU

Arzerra has not yet been approved anywhere for a first-line use, but the companies believe that new data will boost its chances. It is asking for it to be used in combination with an alkylator-based therapy in patients for which a fludarabine-based therapy is not appropriate.

Bill advances case for nationwide track-and-trace databases

The deep divisions in U.S. politics have been more apparent than ever this week, but there was also evidence everyone can pull together. Both Houses of Congress and political parties got behind a bill to set a 10-year deadline for a track-and-trace system that has database implications for drugmakers.

Pfizer, Ligand get FDA nod for hot flash drug Duavee

Pfizer and partner Ligand Pharmaceuticals have gotten a new drug approved to treat hot flashes in some women with menopause. 

Some companies now tout passing plant inspection

Until recently, getting a clean plant inspection by a top regulator would pass unnoticed. Now, some companies see virtue in letting the industry know when they pass an inspection.