The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Roche's Xolair (omalizumab) for the prevention of severe allergic reactions after accidental exposure to one or more foods in people with allergies.
14 Aug 2018
13 Aug 2018
Alnylam Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its RNA interference (RNAi) therapeutic, Onpattro (patisiran) lipid complex injection, to treat polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.
07 Aug 2018
BioCryst Pharmaceuticals’ plasma kallikrein inhibitor BCX7353 has been given fast track designation by the US Food and Drug Administration (FDA) for the prevention of angioedema attacks in patients having hereditary angioedema (HAE).
06 Aug 2018
The European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor which is being developed by AstraZeneca and Merck to treat neurofibromatosis type 1 (NF1).
02 Aug 2018
Pfizer has secured approval from the European Commission (EC) for its Xeljanz (tofacitinib citrate) for the treatment of moderately to severely active ulcerative colitis (UC).
31 Jul 2018
Progenics Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its radiotherapeutic drug Azedra (iobenguane I 131) to treat rare tumors of the adrenal gland (pheochromocytoma or paraganglioma).
30 Jul 2018
Indivior announced that the US Food and Drug Administration (FDA) has approved Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults.
23 Jul 2018
Agios Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Tibsovo (ivosidenib) to treat adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation.
03 Jul 2018
AstraZeneca has secured regulatory approvals for two major cancer drugs, Imfinzi and Lynparza, in Japan.
28 Jun 2018
The US Food and Drug Administration (FDA) has approved Array BioPharma’s oral combination treatment of Braftovi (encorafenib) capsules and Mektovi (binimetinib) tablets for a serious and deadly type of skin cancer.