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FDA

Latest Headlines

Latest Headlines

New report finds Bydureon safest of new class of diabetes drugs

With big money to be made, drugmakers have responded to the global rise in Type 2 diabetes with a host of new classes of treatments that work in different ways. And while that is generally a good thing, the full range of adverse effects of all of these new drugs can't be known until they have been on the market for awhile, and some will fare better than others, a new report states.

Boston Scientific scores FDA approval for a new crop of implantable cardiac devices

Boston Scientific won FDA approval for a new crop of implantable defibrillators and heart failure devices, helping the company move forward with sales and development of its cardiac rhythm management system.

UPDATED: Impax believes manufacturing issues are fixed

Impax Laboratories had its future sidelined by manufacturing problems that set off a domino effect. Now, it says it is ready to get back in the game.

FDA tags yet another Indian drugmaker, Canton Labs, with ban

The FDA sent a warning letter to Canton Laboratories in Vadodara, India, in February for a list of serious infractions, including falsifying data. The agency has taken the next step, issuing an import alert that bans products from the facility.

Lupin recalls more Suprax on purity problems, adding to Indian pharma's quality questions

In the latest black eye for India's pharma industry, Lupin is recalling some 10,000 bottles of its Suprax antibiotic in the U.S. The pills fell short of standards for purity, the FDA said in a statement on its website.

Lupin recalls more Suprax

Rapidly expanding Indian generic drugmaker Lupin has stumbled, having to recall 5 lots of the antibacterial med Suprax (cefixime) because it failed purity tests.

Hamburg to PhRMA: If you don't have quality, the rest doesn't matter

A strong regulatory agency and the patient confidence it inspires are essential for both patients and the industry as a whole, Sanofi CEO Chris Viehbacher said Thursday. And while the FDA has made recent strides in restoring the patient trust the agency depends on, Commissioner Margaret Hamburg says it still has some work to do.

Sources: Sun has blueprint for turning Ranbaxy around

Sun Pharmaceutical execs acknowledge it will be no easy task to repair Ranbaxy Laboratories' damaged reputation with the FDA and the public. But Sun managing director Dilip Shanghvi and his lieutenants came in with a laundry list of actions to be taken quickly to jump-start the process, sources tell Reuters.

Judge likely to boot Massachusetts ban of new opiate Zohydro

After Massachusetts Gov. Deval Patrick banned Zogenix's powerful new FDA-approved painkiller, Zohydro, the company filed a lawsuit arguing the ban was unconstitutional. On Tuesday, federal district court judge Rya Zobel said she was inclined to agree with Zogenix and was leaning towards granting a preliminary injunction that would allow Zohydro to be sold in Massachusetts.

Zogenix sues Massachusetts over ban on controversial painkiller Zohydro

In late March, Massachusetts Governor Deval Patrick banned the newly approved purely hydrocodone pain pill Zohydro--and now the maker of that drug is fighting back. Zogenix filed a lawsuit in a Boston federal court seeking a restraining order against the governor's Zohydro ban.