Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA warns against inappropriate use of fetal ultrasound imaging and heartbeat monitoring

The FDA issued a warning against unnecessary and excessive fetal ultrasound imaging and heartbeat monitoring using Doppler heartbeat monitors, advising women not to receive or perform the procedures at home or for nonmedical reasons.

AstraZeneca snags EU approval for first-in-class cancer fighter Lynparza

AstraZeneca scored European approval for its ovarian cancer-treating drug Lynparza (olaparib), expanding its cancer portfolio at a time when the company is trying to show investors that it's better off independent.

FDA finds issues with Hovione plant in Portugal

The latest FDA visit to Hovione's plant in Loures, Portugal, for a preapproval inspection resulted in a Form 483 with three observations.

Pfizer, Bayer and Boehringer meds win backing from U.K. cost agency

This week, the U.K. National Institute for Health and Care Excellence blessed Pfizer's kidney cancer treatment Inlyta, changed its mind in support of Bayer's prostate cancer therapy Xofigo, and backed Boehringer Ingelheim's anticoagulant Pradaxa for blood clots in the legs and lungs.

Belgium's UCB calls it quits on $1.53B sale of U.S. generic drug unit

Weeks after Belgium's UCB announced that it would sell its U.S. generic drug business for $1.53 billion, the company is calling off the sale in light of regulatory pushback over one of the unit's products.

Sanofi's newly approved intradermal quadrivalent Fluzone forgoes the shot

The FDA approved Sanofi's Fluzone Intradermal Quadrivalent in adults age 18 through 64.

Pozen gets another FDA cold shoulder for its cardio drugs

The FDA again rejected Pozen's pair of treatments designed to help patients deal with cardiovascular disease, citing the same third-party manufacturing issues that tanked the last application. Pozen claims the supplier has since rectified those concerns but that the agency has been less than cooperative in the process.

Roche expands use of next-gen blood tests for organ and tissue screening

Roche got a green light from U.S. regulatory authorities to expand the use of two tests from its cobas assay line used to detect serious viral infections like HIV, hepatitis B and C and West Nile.

FDA approves diagnostic to spot blood cancer-causing virus

Santa Ana, CA-based MP Biomedicals has nabbed FDA approval for the first supplemental test designed to better identify blood donors that have tested positive for human T cell lymphotropic virus.

Roche's Lucentis nabs FDA 'breakthrough' tag for diabetic eye disease

Roche's Lucentis may now have a bigger jump on Eylea in diabetic retinopathy. The Swiss drugmaker's Genentech unit won the FDA's "breakthrough" designation for that indication on Monday. And Lucentis was already on the FDA's priority review track, with a decision date in February.