A campaign accuses the FDA of gender bias for approving drugs to help men have sex, but none for women. The NYT reports.» Read More
A senior scientist at Consumers Union told "Squawk Box" that the U.S. regulators need to step-up inspections of food coming from China, particularly seafood.
Federal health officials said Thursday that they were detaining three types of Chinese fish -- catfish, basa and dace -- as well as shrimp and eel after repeated testing has turned up contamination with drugs unapproved in the United States for use in farmed seafood.
Pfizer said after markets closed Wednesday that U.S. health regulators will approve its novel AIDS drug called maraviroc once certain conditions have been met, although the world's biggest drugmaker did not elaborate on what was necessary to obtain an outright approval.
Gilead Sciences shares rose in aftermarket trading on Friday after the U.S. Food and Drug Administration approved the drugmaker's treatment for high blood pressure in the lungs.
Investors wiped some 6 billion euros ($7.97 billion) off the market value of French pharmaceutical company Sanofi-Aventis Thursday after U.S. federal health advisers rejected its Accomplia weight-loss drug.
GlaxoSmithKline faces a U.S. investor lawsuit claiming that Europe's biggest drugmaker misled shareholders about the safety of diabetes drug Avandia.
Turning the tables on the United States amid growing worries over dangerous Chinese products, Beijing said Friday some health supplements and raisins imported from the U.S. failed to meet China's safety standards and have been returned or destroyed.
Paul Brown, consumer healthcare advocate at the U.S. Public Interest Research Group, told CNBC’s “Morning Call” that the Food and Drug Administration’s post-market safety program is “broken.”
All studies to date provide inconsistent data about the potential contribution of GlaxoSmithKline's diabetes drug Avandia to heart attack risk, the head of the Food and Drug Administration said in testimony prepared for a congressional hearing on Wednesday.
In an exclusive interview on CNBC, GlaxoSmithKline’s CEO J.P. Garnier defended the company's diabetes drug Avandia, saying recent safety questions are based on statistical analysis, not medical evidence.
Before the bell this morning, the ever-popular Dendreon put out a press release ahead of its presentation later today at the Bank of America Healthcare Conference in Las Vegas. You can listen to the presentation via Webcast at 1 p.m. ET. The company says that the Food and Drug Administration has confirmed that it will "accept either a positive interim or final analysis of survival" from the ongoing, larger clinical trial on Dendreon's highly controversial prostate cancer treatment Provenge.
Wyeth's drug Torisel won U.S. approval to treat patients with a type of advanced kidney cancer known as renal cell carcinoma, the Food and Drug Administration said.
A warning issued to MedImmune over manufacturing issues at a United Kingdom plant shouldn't significantly disrupt company production of its nasal spray flu vaccine, federal health officials said.
Vegetable oils, salad dressings, crackers and other oil-containing foods made by PepsiCo's Frito-Lay unit will now carry claims that products with unsaturated fat can curb heart disease risk, U.S. regulators said.
In the middle of the Avandia blowup, GlaxoSmithKline this week is launching the new over-the-counter diet pill "Alli." The company says it's spending 150 million bucks on the first-year marketing of the formerly prescription-only Xenical from Roche.A big chunk of that is going toward a multi-pronged educational campaign to convince dieters they have to change their eating habits and exercise if they want to get the maximum benefit from Alli. That's crucial with this drug because the more fat you eat, the worse the gastrointestinal side effects. Clue: Glaxo is telling Alli users to wear dark pants and bring an extra pair to work. The company has gone so far as to set up an exhibit in New York City this week where people can get more information about Alli.
Women looking for a simple way to avoid their menstrual period could soon have access to the first birth control pill designed to let women suppress monthly bleeding indefinitely.
So, let's start with GlaxoSmithKline's Avandia. The stock is rebounding a little bit today after the pummeling it took yesterday. Once again, the New England Journal of Medicine study saw an "embargo break" by another media outlet. That means the news hit in the middle of the trading day yesterday, catching just about everyone by surprise. The embargo was supposed to have lifted at 5 p.m. ET yesterday, which would have given all of the stakeholders -- chiefly Glaxo -- the ability to issue their prepared press releases at the same time.
While I'm watching the webcast of the FDA Advisory Committee Meeting on the anemia drugs (Amgen, Johnson & Johnson), I wanted to hop on my TV versus print soapbox one more time.As I posted yesterday, I had asked a Dendreon spokeswoman for an interview with CEO Dr. Mitchell Gold in the wake of the FDA sending the company an "approvable letter" for its prostate cancer treatment Provenge.
Shares of Biotech drug maker Dendreon sank more than 50% after the FDA requested more clinical data on the effectiveness of its prostate cancer treatment, Provenge, delaying the drug's approval.
GlaxoSmithKline's Alli (pronounced "ally" -- don't ask me why they put an "i" at the end) is the new over-the-counter version of prescription Xenical from Roche. It's a diet pill, but as I previously blogged, it has potentially embarrassing side effects. On the plus side, GSK says you can subtract 50% more pounds if you use Alli as directed. But, if you still eat too many fatty foods, you could run into trouble.