FDA regulation news from FierceBiotech
NewsFDA puts partial clinical hold on MethylGene program
Canada's MethylGene says that as a result of its voluntary decision to halt enrollment in a new drug study, the FDA has put a partial clinical hold on its lead development program in cancer. The Read more...
Report: FDA lax in clinical trial oversight
A new report has found that the FDA does little to protect the safety of patients who participate in clinical trials. Daniel R. Levinson, inspector general of the Department of Health and Human Read more...
Alcon faces setback on experimental AMD therapy
Shares of Alcon slipped this morning after the eye care giant announced that the FDA would require another trial of its experimental therapy for wet, age-related macular degeneration. Researchers Read more...
Waiting game continues for biogenerics
The folks at BIO are breathing a sigh of relief over Congressman Henry Waxman's comment that new legislation on Read more...
FDA stands firms on need for Thelin trial
The FDA has handed Encysive its fourth--that's right, fourth--dose of bad news for Thelin, a pulmonary arterial hypertension treatment. Encysive received its Read more...
Investors cheer FDA's acceptance of Entereg response
Shares of Adolor took off this morning, climbing 18 percent after the company issued a joint release with GlaxoSmithKline that the FDA had accepted their response to the agency's Read more...
Neurochem hammered on Alzhemed failure
The analysts swiftly began writing off Neurochem's Alzhemed after the company announced last night that its lead drug had failed a late-stage trial for Alzheimer's. The news sent Neurochem's stock Read more...
IDM shares plunge on FDA's rejection
The FDA has turned thumbs down on IDM Pharma's mifamurtide, which was developed to treat a rare form of bone cancer. The agency is looking for more clinical data, says IDM, adding that company Read more...
FDA delay forces cutbacks at GPC Biotech
Struggling to overcome FDA hurdles for its cancer drug satraplatin, Germany's GPC Biotech says it will slash its staff by 15 Read more...
| Press ReleasesPRESS RELEASE: FDA MedWatch - Desmopressin Acetate FDA MedWatch - Desmopressin Acetate - Product Labeling Updated To Include Important New Information About Severe Hyponatremia And Seizures ROCKVILLE, Md., Dec.4, 2007-- FDA notified healthcare Read more... PRESS RELEASE: EXACT Sciences Corporation Says Gets Warning Letter from FDA EXACT Sciences Corporation Says Gets Warning Letter from FDA MARLBOROUGH, Mass. -- EXACT Sciences Corporation announced today that it has received a Warning Letter from the Food and Drug Read more... PRESS RELEASE: Warning Letter on Cymbalta Michele Sharp, Pharm.D. Manager, U.S. Regulatory Affairs Eli Lilly and Company Lilly Technology Center Indianapolis, IN 46221 Re: NDA # 21-733 CYMBALTA® (duloxetine hydrochloride) Delayed-release Read more... PRESS RELEASE: FDA Warning letter to Genzyme Henri A. Termeer Chairman, President and CEO Genzyme Corporation 500 Kendall Street Cambridge, MA 02142 USA Dear Mr. Termeer: The Food and Drug Administration (FDA) conducted an inspection of Read more... PRESS RELEASE: NPS Pharmaceuticals PREOS Granted U.S. Orphan Drug Status for Treatment of Hypoparathyroidism NPS Pharmaceuticals PREOS Granted U.S. Orphan Drug Status for Treatment of Hypoparathyroidism PARSIPPANY, N.J., Sept. 19 -- NPS Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Read more... |
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