Keyword: Food and Drug Administration (FDA)

News

FDA Approves the First-Ever US Biosimilar

16.03.2015 - The US Food & Drug Administration has approved the country's first biosimilar product, a move observers say will open the door for lower cost, generic-like biological drugs. The...

News

American Chemistry Council Launches pro-BPA Campaign

09.03.2015 - The American Chemistry Council (ACC) is launching an advertising campaign in US publications pointing to what it sees as a dismissal of bisphenol A (BPA) as a health threat...

News

AbbVie to Acquire Pharmacyclics for $21 Billion

05.03.2015 - US drugmaker AbbVie has reached final agreement to acquire compatriot Pharmacyclics and the company's flagship asset Imbruvica (ibrutinib), which it describes as "a highly...

News

Actavis Hormonal IUD Wins FDA Approval

03.03.2015 - The US Food and Drug Administration has approved the hormonal intrauterine contraceptive (IUD) Lileta, which releases the hormone levonorgestrel to inhibit thickening of the womb...

News

FDA Eases Path to Genetic Disease Screening

24.02.2015 - The US Food and Drug Administration (FDA) will no longer require preliminary review before companies can sell genetic carrier screening tests to the public. The health watchdog's...

News

Lonza and Tigenix Sign Toll Manufacture Agreement

13.02.2015 - Swiss fine and specialty chemicals producer Lonza has signed a toll manufacturing agreement with TiGenix, an advanced biopharmaceutical company focused on developing and...

News

Merck & Co Hepatitis C Drug to Lose "Breakthrough" Status

06.02.2015 - US regulators intend to rescind the "breakthrough therapy" designation for Merck & Co's hepatitis C combination treatment, a decision that could delay approval of the product by...

Chemistry & Life Sciences

Aesica Secures Continuing FDA Approval of German Sites

03.02.2015 - Aesica it has received continuing FDA approvals for both its bulk manufacturing and packaging operations in Germany. As a consequence, the global pharmaceutical contract...