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Home » Topics » Regulatory

Regulatory
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FDA approves Kynamro for homozygous familial hypercholesterolemia

Jan. 30, 2013

Don’t Call Them Generics!

Jan. 29, 2013
By Mari Serebrov
When the FDA’s Rachel Sherman said the biggest challenge the agency faces with biosimilars is educating the public, she wasn’t exaggerating. An article in the New York Times shows just how big of a challenge it’s going to be. The article “Biotech Firms, Billions at Risk, Lobby States to Limit Generics” slams biotechs for encouraging states to adopt legislation limiting the automatic substitution of biosimilars, which the Times repeatedly called “generics.” As BioWorld Today reported, most of the bills being considered by states would require physician notification of what was substituted, enhanced recordkeeping and an opportunity for doctors (and, in...
Read More

FDA approves three alogliptin-based therapies for type 2 diabetes

Jan. 28, 2013

Novartis receives E.U. approval for Bexsero

Jan. 23, 2013

FDA approves first patch for treatment of migraine

Jan. 18, 2013

FDA approves Protein Sciences' Flublok seasonal influenza vaccine

Jan. 17, 2013

Biocon receives marketing authorization in India for itolizumab

Jan. 10, 2013

FDA approves Kineret for the treatment of NOMID

Jan. 10, 2013

FDA approves Fulyzaq for diarrhea in patients with HIV/AIDS

Jan. 2, 2013

FDA grants accelerated approval for Sirturo in tuberculosis

Jan. 2, 2013
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