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Plasma fibrinogen can be used as a biomarker in interventional clinical trials examining patients at high risk for exacerbations or all-cause mortality in chronic obstructive pulmonary disease, according to final guidance to industry issued by FDA. Read More
FDA granted a Qualified Infectious Disease Product designation to MGB-BP-3, developed by MGB Biopharma, for the treatment of Clostridium difficile-associated diarrhea. Read More
A federal judge rescinded his own verdict backing the FDA’s decision to not grant Ferring exclusivity for its bowel preparation drug Preponik, ruling that the agency must give the company five-years of retroactive exclusivity. Read More
Teva intends to meet with the FDA to renew its efforts to launch a generic version of Mylan’s EpiPen by 2018, after many have called into question the price of Mylan’s allergy treatment. Read More
A federal judge rendered Janssen’s composition patent for Remicade invalid, marking a loss for the company engaged in ongoing efforts to block biosimilar competition. Read More