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FDA approves IND application for coeliac treatment europeanpharmaceuticalreview
August 21, 2019
The FDA has accepted an IND application for AG017, a new drug designed to treat the causes of coeliac disease which will soon enter new trials.
US FDA pulls up Emcure Pharma for manufacturing violations at Pune plant expresspharma
August 21, 2019
American health regulator US Food and Drug Administration (US FDA) has issued a warning letter to Emcure Pharmaceuticals for violating current good manufacturing practice norms at its Pune-based plant.
Emcure Pharmaceuticals receives warning letter from FDA europeanpharmaceuticalreview
August 21, 2019
A warning letter has been sent to Emcure Pharmaceuticals after an FDA facility inspection found that the company did not adequately investigate sterility failures.
FDA approves Nabriva’s antibiotic for pneumonia expresspharma
August 21, 2019
The US Food and Drug Administration said that it had approved Nabriva Therapeutics’ antibiotic Xenleta for treating patients with community-acquired pneumonia.
FDA Approves New Antibiotic to Treat Community-Acquired Bacterial Pneumonia americanpharmaceuticalreview
August 21, 2019
The U.S. Food and Drug Administration has approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.
FDA approves novel device to treat idiopathic scoliosis biospectrumasia
August 20, 2019
The U.S. Food and Drug Administration has approved the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis, called idiopathic scoliosis, that has not responded to conservative treatment o
FDA approves novel treatment for highly drug-resistant forms of TB biospectrumasia
August 20, 2019
Pretomanid, a novel compound developed by the non-profit organization TB Alliance, was approved by the U.S. Food & Drug Administration (FDA), on 14 August 2019, for treating some of the most drug-resistant forms of tuberculosis (TB).
FDA approves INREBIC for Myelofibrosis treatment biospectrumasia
August 20, 2019
Celgene Corporation has announced the U.S. Food and Drug Administration (FDA) has approved INREBIC® (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocyt
AbbVie receives FDA approval for RINVOQ biospectrumasia
August 20, 2019
RINVOQ (upadacitinib) met all primary and ranked secondary endpoints across a variety of patients with moderately to severely active rheumatoid arthritis
Celgene’s bone marrow cancer drug Inrebic secures FDA approval pharmaceutical-technology
August 20, 2019
Celgene has received the US Food and Drug Administration (FDA) approval for the use of its Inrebic (fedratinib) drug to treat adults with myelofibrosis, a rare bone marrow cancer.

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