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FDA OKs InnoPharma ANDA for Lung Diseases

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FDA approves an InnoPharma Inc. ANDA for acetylcysteine solution, USP 20% as adjuvant therapy for patients with certain lung disea...

Researchers Working on Better Hip Replacement Metal

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Researchers report in an American Chemical Society publication they are making progress in findings ways to use tantalum as a hip ...

10 Big Pharma Companies Unite on Clinical Trial Collaboration

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Ten of the top biopharmaceutical companies join forces to improve clinical trial quality and speed drugs to patients.

FDA Wont Revoke OxyContin Labeling

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FDA says it will not revoke approval for OxyContin labeling and call it misleading.

AstraZeneca Introduces Education Program for Brilinta Patients

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AstraZeneca breaks an education program for coronary patients taking Brilinta.

Research Favors Genetic Model for PK/PD Testing

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Researchers comparing four different methodologies for pharmacokinetic and pharmacodynamic testing of the anti-melanoma agent carb...

Research Favors Genetic Model for PK/PD Testing

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Janssen Biotech files a BLA seeking approval for an investigational intravenous formulation Simponi for treating adults with moder...

FDA Removes Warning for Cattle Feed

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Federal Register Final rule: FDA amends the animal drug regulations to remove a warning for growing cattle and to codify all monen...

Chinese Drug Firm Terminates FDA Inspection

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FDA says it found significant CGMP violations at Chinas Fercy Personal Care Products during an inspection cut short by the company...

FDA OKs First Breast Ultrasound for Dense Breast Tissue

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FDA approves U-Systems some-v Automated Breast Ultrasound System, the first ultrasound device for use in combination with a standa...