Topic:

Regulatory

Latest Headlines

Latest Headlines

Vesiflo gets regulatory green light to market replaceable urinary prosthesis device for women

In a regulatory win, Washington's Vesiflo got an FDA green light to market its replaceable urinary prosthesis for female adults with bladder drainage problems.

FDA cracks down on Little City Dogs' compounded copies of popular pet meds

Turns out it's not exactly legal for pharmacies like Little City Dogs to mass-market cheap copies of veterinary drugs like Capstar, which is made by Novartis Animal Health. Now the FDA has informed the company of the violation, via a harshly worded letter the agency posted recently on its website.

AstraZeneca's $2B cancer contender lines up for EU scrutiny

AstraZeneca is expecting word from European regulators next week on whether they'll recommend approval for its new ovarian cancer treatment, a drug the company hopes can bring in $2 billion a year at its peak.

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.