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The Motley Fool July 5, 2006 Rich Duprey	Flu Vaccine Deja Vu The country's largest vaccine maker, Sanofi Aventis, gets an FDA warning letter reminiscent of the 2004 debacle.
The Motley Fool December 10, 2004 Rich Duprey	Regulators Quarantine Chiron The FDA sends a warning letter on the heels of a suspension extension by British authorities. Whether shares of the pharmaceutical ultimately finish up or down, the one-two punch from U.S. and British authorities still points to an ailing company.
The Motley Fool October 5, 2004 Alyce Lomax	No Cheer for Chiron A U.K. regulatory body suspended its manufacturing license because of contamination. The company's misstep adds up to another rough flu season.
The Motley Fool May 17, 2007 Brian Lawler	MedImmune Gets the Thumbs-Up An advisory panel recommends expanded use for one of MedImmune's drugs.
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 October 6, 2004 Rich Duprey	Chiron Sneezes, Investors Catch Cold British authorities shut down the pharmaceutical's only U.S. flu vaccine manufacturing facility. This may in fact be an opportunity to scoop up a beleaguered stock at fire sale prices.
The Motley Fool June 17, 2005 W.D. Crotty	Biotech's Apple Dumpling Gang Chiron has made a number of financial and planning mistakes in the production of its flu vaccine.
The Motley Fool May 5, 2008 Brian Orelli	A Short Wait for Discovery Labs? The company gets a third letter about Surfaxin, but should be able to satisfy the FDA soon.
The Motley Fool May 26, 2005 Brian Gorman	Flu Vaccines' Unhealthy Competition The vaccine business is notoriously tricky. Given the nature of the business, respectable returns are predicated on high volumes. New competitors in the flu-fighting niche could make all companies worse off.
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 March 1, 2004 Alyce Lomax	MedImmune Under the Weather After short-term setbacks, the biotech turns to the long term.
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 December 18, 2007 Brian Lawler	Cervarix Won't Save Glaxo Yet The FDA has another delay for this HPV vaccine. The agency has completed its review, but still has questions.
The Motley Fool December 13, 2011 Frank Vinluan	N.C. Novartis Site Is First Cell-Based Flu Vaccine Facility in the Country A Novartis' vaccine facility in North Carolina today became the first facility authorized by the FDA for emergency use during a pandemic.
The Motley Fool January 16, 2007 Brian Lawler	MedImmune's Improved Flu Vaccine One of the three most important traits for a drug's success is convenience in dosing, so investors should be mindful of the FDA's actions on FluMist, MedImmune's nasal spray vaccine, in the coming months.
The Motley Fool August 1, 2007 Brian Lawler	Elan Gets a Vote of Confidence Elan receives some good news from an FDA advisory panel in the form of a recommendation to expand the use of Tysabri to treat Crohn's disease.
The Motley Fool May 27, 2005 Rich Duprey	Glaxo's Flu Vaccine Booster The drug giant's return could give the U.S. flu vaccine market a shot in the arm.
The Motley Fool December 7, 2004 Brian Gorman	ID Biomedical's Shot in the Arm The company appears well-positioned for the coming years, but it may be best to stay cautious on the company.
The Motley Fool December 6, 2010 Brian Orelli	3-Month Delay? No Problem! Investors shrug off HGS' Benlysta delay. The Food and Drug Administration's delaying its decision on whether to approve Human Genome Sciences and GlaxoSmithKline's Benlysta shouldn't come as much of a surprise.
The Motley Fool June 26, 2008 Brian Lawler	Gauging Glaxo's Vaccine Value Surprise! The FDA actually approves Glaxo's new combination children's vaccine without delay.
The Motley Fool July 28, 2005 Rich Duprey	Chiron's Tragic Quarter The biotech vaccine maker barely breaks even but boasts of its ability to meet full-year expectations.
The Motley Fool February 14, 2005 Rich Duprey	Chiron Probe Goes Formal SEC upgrades investigation into vaccine manufacturer. Was Chiron was as surprised by the contamination debacle as investors and U.S. regulators were?
The Motley Fool October 22, 2004 Rich Duprey	Chiron Reports Profit, But So What? The flu vaccine debacle overshadows the company's profits and earnings.
The Motley Fool February 23, 2004 Brian Gorman	Abbott Cleans Up Its Act Abbott closes the books on its problems with the FDA and clears the way to a spinoff. Abbott finally passed FDA muster with its Illinois diagnostics plant. Its multi-year problem highlights the importance of investors monitoring manufacturing while watching a pharmaceutical company's pipeline. And with its FDA compliance issues behind it, Abbott can look forward to spinning off its Hospital Products Division.
Chemistry World April 8, 2014 Emma Stoye	Contamination troubles strike GSK Pharma giant GlaxoSmithKline has been warned by the US Food and Drug Administration to address manufacturing problems at the SmithKline Beecham chemical plant in Cork, Ireland, after FDA inspectors found evidence of contamination.
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.
The Motley Fool December 21, 2004 Rich Duprey	Chiron Requests a Second Thought Had the vaccine maker simply issued a press release with the incorrect information, it might be understandable, but investors might feel more at ease if it had gotten it right when it filed documents with the SEC.
The Motley Fool February 23, 2010 Brian Orelli	The End of a Swine Flu Era A Food and Drug Administration advisory panel recommended yesterday that next year's seasonal flu vaccine contain the vaccine for the H1N1 virus, aka the swine flu.
The Motley Fool June 15, 2007 Brian Orelli	Get Your Uncle to Pay for Your Capital Improvements MedImmune and Sanofi-Aventis recently announced that they had convinced the U.S. government to pick up a majority of the tabs to renovate their plants. There aren't too many industries where you can invest in companies that get free money from the government.
Food Processing October 2007	Regulatory Issues: FDA reports on allergen contamination If the food industry continues to show awareness of the dangers of food allergens, FDA and Congress likely will continue with a measured and deliberative approach.
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 June 14, 2005 Rich Duprey	Chiron's Credit Conundrum Standard & Poor's downgrades the biotech's credit rating on seemingly old news. Why now?
The Motley Fool February 21, 2008 Brian Lawler	A Bit of Irony From the FDA The agency has a mixed message on drug importation, as evidenced in the recent possible contamination of China-produced Heparin.
The Motley Fool April 1, 2011 Travis Hoium	Optimer Pharmaceuticals Shares Popped: What You Need to Know Shares of Optimer Pharmaceuticals jumped 12% today after positive news from the FDA was released.
The Motley Fool September 7, 2005 Rich Duprey	Is Chiron Worth It? The vaccine maker rejects Novartis' bid of $40 a share as inadequate. How much should the pharma pay? Investors, take note.
The Motley Fool October 18, 2005 Rich Duprey	Chiron's Sickly Forecast The flu vaccine maker further reduces its estimated dose production. With its earnings release due next week, perhaps Chiron was simply preparing investors for a jolt.
The Motley Fool August 23, 2010 Brian Orelli	No Way to Jazz Up This Result Jazz Pharmaceuticals investors went from ecstatic to devastated in less than a week.
The Motley Fool June 20, 2011 Brian Orelli	See Drug, Approve Drug An approval of Regeneron's macular degeneration Eylea looks likely.
The Motley Fool August 12, 2008 Brian Lawler	The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers?
The Motley Fool May 11, 2010 Brian Orelli	Swine Viruses Strike Again In March, the FDA recommended that doctors stop using GlaxoSmithKline's Rotarix, but still hasn't made a final decision on the drug.
The Motley Fool July 31, 2007 Brian Lawler	Avandia Can Stay An FDA advisory panel votes to allow GlaxoSmithKline's top diabetes compound, Avandia, to remain on the market.
Chemistry World April 24, 2007 Victoria Gill	AstraZeneca Scoops up $15.6 Billion Vaccine Business AstraZeneca has joined the race to scoop up acquisition opportunities in the biologics sector with a $15.6 billion deal to buy U.S. vaccines and biotechnology company MedImmune.
The Motley Fool June 21, 2007 Brian Lawler	Pfizer Gets Held Up The FDA issues an approvable letter for its novel HIV compound. Investors, take note.
The Motley Fool October 30, 2006 Brian Lawler	MedImmune's Mediocre Quarter Some patient folks may be willing to wait on MedImmune to turn things around and justify its high valuation, but most other investors should be able to find better value elsewhere in the biotech industry.
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 December 5, 2005 W.D. Crotty	Cashing In on Noven's Drug Patch An FDA advisory panel recommends approval of Noven's patch for attention deficit hyperactivity. For now, investors might be put off by the company's lofty valuation of 55 times trailing earnings.
The Motley Fool December 13, 2007 Brian Orelli	Merck's Vaccination Woes Merck announces it is recalling 1.2 million doses of a vaccine that immunizes children against Hib, which causes meningitis, pneumonia, and other serious infections.
The Motley Fool March 19, 2007 Brian Lawler	Is Dendreon Doomed? A pivotal FDA regulatory meeting approaches for the development-stage pharma. Investors, take note.
The Motley Fool January 22, 2008 Brian Lawler	Adolor Under the FDA's Spotlight The FDA releases its documents on Adolor's lead drug, with surprising good news in advance of an advisory panel discussion. Investors, take note.
The Motley Fool April 11, 2008 Brian Lawler	Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.