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Chemistry World June 10, 2013 Phillip Broadwith |
Sandoz manufacturing woes continue Sandoz, the generic drugs arm of Swiss firm Novartis, has had an official warning from the US Food and Drug Administration over failings at one of its manufacturing plants. |
The Motley Fool July 30, 2010 Brian Orelli |
A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs. |
The Motley Fool February 16, 2010 Brian Orelli |
For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward. |
Pharmaceutical Executive November 1, 2008 Patrick Clinton |
Over There Is it the FDA's responsibility to be in charge of inspections at foreign pharmaceutical plants? |
The Motley Fool August 9, 2010 Brian Orelli |
Dendreon's in Trouble Provided you call a slap on the wrist from the FDA "trouble." |
The Motley Fool January 25, 2010 Brian Orelli |
No Way to Hide This Drug Approval FDA trumps Acorda on its good news. The biotech announced Food and Drug Administration approval of Ampyra, its drug to help multiple sclerosis patients walk better after the markets closed on Friday. |
The Motley Fool December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
The Motley Fool March 7, 2008 Brian Lawler |
A Little Too Much Drug Variability Another drugmaker has to recall batches of its compound. |
The Motley Fool September 24, 2008 Brian Orelli |
Hey, You! Stop! The FDA has ordered Baxter and Hospira to stop making their ophthalmic balanced salt solutions within 60 days. |
The Motley Fool August 12, 2010 Brian Orelli |
Turnaround Signal, or Just Noise on the Decline? Boston Scientific clears up an FDA warning letter -- four years later. |
The Motley Fool April 10, 2008 Brian Orelli |
The News for Baxter Just Got Worse These heparin-related deaths aren't associated with Baxter's product, but they still might spell trouble for the company. |
The Motley Fool May 27, 2010 Brian Orelli |
This Rabid Agency Could Permanently Damage Your Portfolio The FDA has gotten a little out of control. The wonkiness of the FDA's actions makes it hard for investors to figure out what the agency will do. |
The Motley Fool June 1, 2010 Brian Orelli |
Save Your Money, Dendreon As much as doctors would like to prescribe Dendreon's Provenge for their patients, manufacturing limitations will keep demand outpacing supply for awhile. |
The Motley Fool December 27, 2010 Brian Orelli |
FDA Kicks Dust on Alimera's Fairy Tale Eight months after its IPO, Alimera gets hammered. |
The Motley Fool September 9, 2010 Brian Orelli |
Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September. |
The Motley Fool June 18, 2010 Brian Orelli |
Double the Approvals! Double the Fun! These twins will take it. sanofi-aventis and Novartis both received FDA approvals for their cancer drugs yesterday. |
IndustryWeek October 19, 2011 |
FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies? |
Chemistry World July 16, 2015 Rebecca Trager |
US import ban imposed on Indian pharma firm The US Food and Drug Administration has prohibited India's Emcure Pharmaceuticals from importing drugs manufactured at its Maharashtra-based facility into the US owing to concerns over its manufacturing practices. |
The Motley Fool June 25, 2010 Brian Orelli |
Mark Your Calendars: Obesity Drugs Take Center Stage Orexigen Therapeutics has been given an FDA advisory committee meeting date, completing the dates for the trio of obesity drugs up for review. |
The Motley Fool February 22, 2011 Brian Orelli |
A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S. |
The Motley Fool December 31, 2007 Brian Lawler |
The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency. |
The Motley Fool March 31, 2011 Brian Orelli |
Drug Warning Labels: The Good, Bad, and Ugly Once a drug is approved, investors can't fall asleep and ignore FDA announcements about drugs. They come in different varieties, but warnings tend to be of the bad and ugly variety more often than the good. |
The Motley Fool September 15, 2010 Brian Orelli |
Drug Approved. Now Let's Sell This Baby! With ink still wet on its FDA approval, Savient continues its plan to find a buyer. |
The Motley Fool June 16, 2009 Brian Orelli |
Going Viral, but Not in a Good Way Genzyme's manufacturing problems with viruses underscore the complexity of manufacturing biologic drugs compared to small molecule drugs. |
Chemistry World September 18, 2008 James Mitchell Crow |
Ranbaxy hit by US drug ban The US Food and Drug Administration (FDA) has banned the import of more than 30 drugs made by Ranbaxy, India's largest drugmaker. |
Pharmaceutical Executive April 1, 2011 |
Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help. |
The Motley Fool September 18, 2008 Brian Orelli |
Ranbaxy's Troubles Won't Help Competitors The FDA will block the importing of more than 30 drugs and ingredients until Ranbaxy's problems at two Indian manufacturing plants are resolved. |
The Motley Fool February 29, 2008 Brian Orelli |
Bigger Recall, No Big Deal Baxter increases its recall of heparin, but investors shouldn't be that worried. |
The Motley Fool June 3, 2011 Brian Orelli |
FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully. |
The Motley Fool November 14, 2007 Brian Lawler |
Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years. |
The Motley Fool February 26, 2011 Brian Orelli |
FDA Applications and a Look Ahead It isn't pretty. |
The Motley Fool April 5, 2010 Brian Orelli |
1 Month to Go! Is Dendreon a Buy? Only if you understand the risks. |
The Motley Fool October 19, 2010 Brian Orelli |
Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency. |
The Motley Fool October 19, 2010 Brian Orelli |
When the Status Quo Is a Big Win The lack of an FDA rejection will do just fine. Amgen and Johnson & Johnson seemed to get through the FDA advisory panel process without much problem yesterday. |
InternetNews June 13, 2005 Roy Mark |
Fake Canadian Drug Sites Proliferating New study shows 80 percent of sites claiming to be Canadian drug stores are registered in other countries. |
The Motley Fool August 17, 2007 Brian Orelli |
Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully. |
The Motley Fool March 28, 2011 Brian Orelli |
Investors Jump for Yervoy! The Food and Drug Administration approval of Bristol-Myers Squibb's Yervoy came with some surprising labeling news. |
The Motley Fool January 15, 2010 Brian Orelli |
Oops, Sorry About That, Pfizer The FDA says there's no problem with Spiriva after all. |
The Motley Fool March 8, 2010 Brian Orelli |
Really? A 59% Share Price Jump for That? Justified or not, InterMune skyrockets ahead of an FDA panel meeting. |
The Motley Fool April 7, 2011 Brian Orelli |
Drug Approved! But Where's the Name? AstraZeneca prepares to cash in on a minuscule market. |
The Motley Fool November 19, 2009 Brian Orelli |
This Stock Is a Train Wreck Genzyme's string of missteps has investors nervous. |
The Motley Fool July 13, 2010 Brian Orelli |
A Triple Delight: 3 Stocks All Up More Than 10% What's good for the obese goose is good for the gander when it comes to new drug treatments for losing weight. |
The Motley Fool March 3, 2009 Brian Orelli |
A Tale of 2 Weeks It's been a busy two weeks at Genzyme as two nasty notes from the FDA follow two approvals. |
Pharmaceutical Executive September 1, 2008 Jill Wechsler |
Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches. |
The Motley Fool February 26, 2009 Brian Orelli |
Ranbaxy Spoils It for Everyone The Food and Drug Administration claims that generic-drug maker Ranbaxy falsified data that it submitted to the agency. Other innocent drug companies may suffer from guilt by association. |
The Motley Fool April 26, 2011 Brian Orelli |
There Is Only Downside in Consensus Hepatitis C advisory panels will almost certainly recommend approval. Almost. |
The Motley Fool May 31, 2011 Brian Orelli |
Pay Attention, Biotech Investors Competitors and partners can't be ignored. |
Managed Care October 2003 John Carroll |
Massachusetts City Attempts To Import Drugs From Canada The outgoing mayor of Springfield, Mass., is taking on the FDA over his plan to buy medications at a discount from Canada. |
The Motley Fool September 16, 2008 Brian Lawler |
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site. |
The Motley Fool May 26, 2011 Brian Orelli |
Congress Sets Bad Precedent With AVANIR What happened to free markets? |