Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

FTC plows ahead in pay-for-delay suit over AbbVie's AndroGel

The Federal Trade Commission is urging a Pennsylvania federal court to move forward with its pay-for-delay lawsuit against AbbVie, rejecting the company's arguments that it did not keep a generic version of its testosterone powerhouse AndroGel off the market and contending that the suit meets a precedent set last year by the U.S. Supreme Court.

Fresh off Afinitor failure, Novartis turns tide with Signifor LAR approval

It's been a good news, bad news week for Novartis and its oncology business. Monday, the Swiss drugmaker won FDA approval for a long-acting version of Signifor, to treat acromegaly, a rare endocrine disorder. But Friday, Novartis announced that Afinitor fell short in a HER2-positive breast cancer trial, dashing hopes for what could have been a lucrative new indication.

Novartis wins an FDA nod for a long-acting spin on its rare disease drug

The FDA signed off on a once-a-month version of Novartis' Signifor designed to treat acromegaly, a rare growth hormone disorder that can lead to disfigurement and death.

Medtronic launches biofragmentable, injectable nasal packing and stent for sinus surgery

Medtronic has launched NovaShield Injectable Nasal Packing and Stent for functional endoscopic sinus surgery after an FDA approval in October. It's a gel made from chitosan that's placed in the sinus or nasal cavities after the surgery.

Lilly's blockbuster hopeful Cyramza nabs key new use in lung cancer

The plan for Eli Lilly's Cyramza has always been to rack up a string of approvals to vault the drug into blockbuster territory. As of Friday, the Indianapolis drugmaker is one step closer to achieving that goal.

Bayer runs into another German roadblock in marketing vision drug Eylea

Germany's cost-effectiveness watchdog said Bayer eye drug Eylea doesn't perform any better than its Novartis rival, Lucentis, as a treatment for diabetic macular edema.

FDA clears laser-based comb to combat hair loss

The FDA has just cleared two new phototherapy devices manufactured by Lexington International under the brand HairMax for the treatment of hereditary hair loss.

Roche and Exelixis head to the FDA with their melanoma combo

Partners Roche and Exelixis are making their case to regulators with a melanoma-treating combination therapy, filing an FDA application for the fast-tracked treatment as they await European clearance.

Stada, Dr. Reddy's and others dodge German drug suspensions with appeals

A host of drugmakers will not have to pull from the market, at least for now, generic drugs that German regulators say are suspect. The companies have bought some time with appeals of a decision by regulators to nix sales of dozens of medications because of flaws in clinical trials handled by an Indian contractor.