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Amgen's biosimilar of AbbVie's Humira gets FDA approval

FDLI SmartBrief | Sep 26, 2016

Amgen's Amjevita, or adalimumab-atto, a biosimilar version of AbbVie's anti-inflammatory drug Humira, has been approved by the FDA to treat conditions including psoriatic arthritis, rheumatoid arthritis, psoriasis and Crohn's disease. The drug is the fourth biosimilar approved by the agency. Reuters (09/23) The Wall Street Journal (tiered subscription model) (09/23)


Sarepta's DMD treatment approved by FDA

FDLI SmartBrief | Sep 20, 2016

Lannett's treatment for opioid addiction OK'd by FDA

FDLI SmartBrief | Sep 21, 2016

4 drugs from Hungary plant recalled by Teva

FDLI SmartBrief | Sep 23, 2016

UN pledges to eradicate drug-resistant infections

FDLI SmartBrief | Sep 22, 2016

Release of draft guidance for biosimilar interchangeability moved by FDA

FDLI SmartBrief | Sep 23, 2016

Listeria risk prompts recall of Kellogg's Eggo Waffles

FDLI SmartBrief | Sep 20, 2016

Recommendations on device evaluation system released by FDA planning board

FDLI SmartBrief | Sep 26, 2016

BARDA grants up to $132M to The Medicines Co. for antibiotic development

FDLI SmartBrief | Sep 22, 2016

Final guidance on generic facilities' self-identification issued by FDA

FDLI SmartBrief | Sep 23, 2016


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Happening tomorrow! Advertising & Promotion Conference, Sept. 27-28, Washington, D.C.

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Register by Sept. 30 and save! Journal Symposium: Law and Food Systems: Institutional Pathways toward a New Paradigm? Nov. 4

FDLI SmartBrief | Sep 26, 2016

Register by Sept. 29 and SAVE! Introduction to Medical Device Law and Regulation Course, Nov. 2-3, Washington, D.C.

FDLI SmartBrief | Sep 23, 2016

Advertising & Promotion Conference, Sept. 27-28, Washington, D.C.

FDLI SmartBrief | Sep 23, 2016

Journal Symposium: Law and Food Systems: Institutional Pathways toward a New Paradigm? Nov. 4, Georgetown University Law Center

FDLI SmartBrief | Sep 22, 2016




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