Topic:

Regulatory

Latest Headlines

Latest Headlines

Age-related macular degeneration device wins FDA approval in patients aged 65+

The FDA approved VisionCare Ophthalmic Technologies' Implantable Miniature Telescope in patients with bilateral end-stage age-related macular degeneration aged 65 or older, the company announced today.

Eisai wins FDA nod for a drug to treat chemo-caused nausea

Eisai and partner Helsinn secured the FDA's blessing to market Akynzeo, a combination treatment designed to prevent nasuea and vomiting among cancer patients undergoing chemotherapy.

Pfizer breast cancer prospect grabs FDA's speedy review promise

Pfizer's pipeline could use a big approval, and it may have one coming in palbociclib.

Eisai adds to chemo side-effects franchise with FDA nod for Akynzeo

Months after launching a regulatory battle to extend exclusivity for two of its best-selling products, Eisai won FDA approval for its Akynzeo drug to treat common side effects in patients undergoing chemotherapy.

Pfizer nabs a fast FDA review for breast cancer pipeline star palbociclib

Pfizer has picked up a priority review designation for its closely watched cancer drug palbociclib, potentially slicing four months off the review timeline for a therapy that is being hustled along at an accelerated rate.

Gilead wins FDA approval for its hep C combo pill, a blockbuster in the making

Gilead Sciences picked up a much-anticipated FDA approval for Harvoni, a combination therapy for hepatitis C that promises to cure the majority of patients without the need for painful injections that have plagued patients for years.

Prosensa heads to the FDA with its once-failed DMD treatment

Prosensa has begun the FDA submission process for its treatment for Duchenne muscular dystrophy, planning to fully file by year's end with hopes of finally winning approval for a drug that has survived a few brushes with failure.

Exact Sciences nails coveted Medicare coverage for colon cancer DNA test

Exact Sciences now has something that diagnostics companies find increasingly hard to obtain: Medicare coverage, obtained for its new cutting-edge colorectal cancer-screening test.

Report warns of cyberattacks against medical devices to extort money

Medical device cyber security concerns were aroused when a baddie in the show Homeland hacked into the vice president's pacemaker and initiated a fatal heart attack. Now, a report by the European Cybercrime Centre warns of the real rise of similar "ransomware" attacks, although financial gain, not murder, would be the goal.

PhRMA renews legal battle over big hospital discounts for orphan drugs

Last October, the Pharmaceutical Research and Manufacturers of America (PhRMA) sued the federal government over a rule that allowed some hospitals to get orphan drugs at a steep discount. At first, it looked like the trade group had prevailed, because in May, a federal court struck down the authority of the U.S. Health Resources and Services Administration (HRSA) to enforce the rule.