Intercept Pharmaceuticals, Inc. announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of… read more.
Alexion Pharmaceuticals announced that the European Commission has approved Ultomiris (ravulizumab)—the first and only long-acting C5 complement inhibitor administered every eight weeks*—for the treatment of adults and children… read more.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced its decision to discontinue the Phase III LOTUS study of Stelara (ustekinumab) in Systemic Lupus Erythematosus (SLE) due to… read more.
Abbott announced new data from the company’s LightLab Initiative that showed optical coherence tomography (OCT) imaging significantly changes how physicians decide to treat a vessel compared to traditional… read more.
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Qutavina (teriparatide), from EuroGenerics Holdings,… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Gencebok, intended for the… read more.
CSL Behring announced that it has agreed to acquire exclusive global license rights to commercialize an adeno-associated virus (AAV) gene therapy program, AMT 061 (etranacogene dezaparvovec), for the… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Aybintio, intended for the… read more.
Hansa Biopharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending conditional approval of… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Livogiva ( formerly PF… read more.
The European Medicines Agency has recommended the refusal of the marketing authorisation for Turalio, a medicine intended for the treatment of tenosynovial giant cell tumour from Plexxicon/Daiichi Sankyo…. read more.
Chiasma, Inc. announced that the FDA approved Mycapssa (octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide…. read more.
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