Topic:
Regulatory
Latest Headlines
Latest Headlines
Sagent recalls paralyzing agent made by MN Pharmaceuticals
Sagent Pharmaceuticals, which relies primarily on contract manufacturers, is recalling a paralyzing agent used in surgery that is manufactured at a plant in Turkey. The company said testing found a high level of impurities.
Obama administration allowing Teva's Plan B for all ages
Trying to limit access to Teva Pharmaceutical Industries' emergency contraceptive Plan B One-Step and other similar birth control drugs has been a long battle, but the government has finally decided to cut its losses. As of Monday, it will no longer be fighting for age-based restrictions on over-the-counter availability.
Exact wraps up FDA submission as investors keep a watchful eye
Exact Sciences has completed its three-step process to win FDA approval for a stool-based cancer diagnostic, submitting the same data that spooked investors back in April with hopes of convincing the agency.
Gilead gains FDA's inside track for hep C drug sofosbuvir
The FDA announced that regulators are providing a priority review for the treatment, potentially lopping four months off of the review process.
Battle of weight-loss drugs begins as Arena launches Belviq next week
The long-awaited battle between two weight loss drugs is ready to begin. With its launch for Belviq delayed by the DEA, Arena has had to sit back and watch competitor Vivus pass it by with its own weight-loss drug. Now, nearly a year after the FDA cleared Belviq for approval, investors will get the chance to see if it can outperform its underwhelming competitor, Qsymia.
UPDATED: FDA advisers vote for looser reins on GlaxoSmithKline's Avandia
It took multiple tries and a vote tallied on paper to make sure everything was correct, but finally, we have a verdict. After two days of hearings, on Thursday an advisory panel recommended the FDA keep Avandia on the market and ease restrictions on its use.
Court orders immediate access to some emergency contraceptives
You win some, you lose some. That's the state of affairs on emergency contraception today, at least from the FDA's point of view. The government lost its bid to delay open access to some emergency "morning-after" pills--but won court concession on the others.
Australia packager gets FDA warning letter
A warning letter has been issued to Contract Pharmaceutical Services of Australia, which does drug packaging at a plant in the Sydney suburb of New Ryde.
Indian litigation seeks to close Ranbaxy plants
While Ranbaxy's cover-up of shoddy manufacturing eventually led to a guilty plea and a $500 million penalty in the U.S., there have never been any consequences in its home country of India. Recent public outrage has prompted a stir among government officials about the matter, but some in the public are taking matters into their own hands.
FDA official, panelists challenge Avandia safety trial
Dr. Thomas Marciniak, medical team leader of FDA's Division of Cardiovascular and Renal Products, made some expensive promises Wednesday morning before a panel of outside experts tasked with advising the FDA on whether to lift current restrictions on GlaxoSmithKline's diabetes drug Avandia.
