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Oral Azacitidine Advances to Multi-Center, Multi-Cycle, Dose Escalation Study
Pharmion Corporation announced that the multi-center, open label Phase 1 clinical trial of single dose oral azacitidine in patients with MDS, AML and ...

Pharmacyclics Announces FDA Filing of New Drug Application for Xcytrin Injection to Treat Lung Cancer Brain Metastases
Pharmacyclics announced that the U.S. Food and Drug Administration (FDA) has filed the company's New Drug Application (NDA) for Xcytrin (motexafin gad...

Warnex successfully passes FDA inspection of its bioanalytical facilities
Warnex reported the favourable outcome from an inspection of its facilities performed by the U.S.Food and Drug Administration (FDA) and completed on A...

Worldwide Fish & Seafood, Inc. Enters Consent Decree with FDA
The U.S. Food and Drug Administration (FDA) announced that Worldwide Fish & Seafood, Inc., Minneapolis, MN, (doing business as Coastal Seafood) a sea...

Abraxis BioScience Receives FDA Tentative Approval for Fosphenytoin Sodium Injection, USP
Abraxis BioScience, an integrated, global biopharmaceutical company, announced that it has received a tentative approval from the U.S. Food and Drug A...

Protalix BioTherapeutics Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
Protalix BioTherapeutics announced that it has received written notice from the United States Food and Drug Administration (FDA) that it may initiate ...

Shelhigh Responds to FDA Allegations
FDA investigators and U.S. Marshals recently seized all implantable medical devices from Shelhigh, Inc. after FDA inspectors claimed significant defic...

Boston Scientific Announces FDA Approval of Innovative Heart Failure Lead
Boston Scientific Corporation announced U.S. Food and Drug Administration (FDA) approval of the ACUITY(R) Steerable left ventricular lead for use with...

FDA Accepts GPC Biotech's Satraplatin NDA for Filing and Grants Priority Review Status
GPC Biotech AG announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for satrapl...

FDA Announces Recommendations to Reauthorize Medical Device User Fee Program
The U.S. Food and Drug Administration (FDA) proposed recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act (...

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