THE US Food and Drug Administration (FDA) FDA charged Ranbaxy Laboratories’, Paonta Sahib facility, India has falsified data and test results in approved and pending drug applications.
13/03/2009
ABBOTT Laboratories has announced it has received FDA approval for its Abbott Prism HIV O Plus screening test.
21/09/2009
SAGENT Pharmaceuticals has announced FDA approval of its Azithromycin for Injection therapy developed for treatment of bacterial infections.
31/03/2009
SPECTRUM Pharmaceuticals has announced the FDA has granted Fast Track Designation for the investigation of apaziquone (EOquin) for the treatment of non-muscle invasive bladder cancer.
24/07/2009
THE FDA has amended warning letters sent in March 2009 to nine companies asking them to stop manufacturing 14 unapproved narcotic drugs after realising the desperate need of one unapproved drug.
21/04/2009
THE US Food and Drug Administration (FDA) has released “Influenza: Developing Drugs for Treatment and Prophylaxis,” a draft guidance for industry.
06/03/2009
ALLERGEN has announced it has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company's Supplemental Biologics License Application (sBLA) for BOTOX (Botulinum Toxin Type A) to treat upper limb spasticity in post-stroke adults.
28/05/2009
VGX PHARMACEUTICALS has announced the filing of a Device Master File (MAF) amendment with the FDA for its patented electroporation device for use with intradermal electroporation (ID-EP).
17/02/2009
DIGIRAD has received 510(k) clearance from the FDA which will enable the company to market and manufacture its Cardius X-ACT imaging system.
31/03/2009
THE LEADING artemisinin-based combination treatment (ACT) for malaria worldwide, Coartem, has been approved by the FDA.
09/04/2009
THE LEADING artemisinin-based combination treatment (ACT) for malaria worldwide, Coartem, has been approved by the FDA.
09/04/2009
ALLERGAN has announced it has received approval from the United States Food and Drug Administration (FDA) for Acuvail (ketorolac tromethamine ophthalmic solution).
28/07/2009
ORTHO CLINICAL Diagnostics has received the FDA's approval for a diagnostic assay for the detection of antibodies to human immunodeficiency virus types 1+2 for use on the Vitros 5600 integrated and Vitros 3600 immunodiagnostic systems.
16/10/2009
The US Food and Drug Administration (FDA) has granted Roche emergency use authorisation for its Realtime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus.
20/11/2009
NOVARTIS has announced the FDA approval of Extavia, the first in the company’s portfolio of planned multiple sclerosis (MS) therapies to help patients suffering the disease.
24/08/2009
DIAGNOSTIC HYBRIDS has announced the FDA clearance of the Thyretain TSI Reporter BioAssay for marketing under the 510(k) pre-notification process.
31/08/2009
THE FDA advisory committee have met to discuss the new drug application (NDA) for Bayer’s rivaroxaban.
25/03/2009
MYLAN has announced that Matrix Laboratories has received the first and only tentative approval from the US Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief.
13/03/2009
Roche has announced that the US Food and Drug Administration (FDA) has approved its cobas TaqScreen MPX Test for screening pooled source plasma for human immunodeficiency virus (HIV) RNA, hepatitis C virus RNA and hepatitis B virus DNA.
08/12/2009
The US Food and Drug Administration (FDA) has approved Rituxan/MabThera (rituximab) plus fludarabine and cyclophosphamide (FC) chemotherapy for people with either previously untreated (first-line) or previously treated (relapsed or refractory) CD20-positive chronic lymphocytic leukemia (CLL).
22/02/2010