Approvals

Onspira’s bronchiolitis obliterans treatment secures FDA orphan drug status

Onspira Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its investigational product, OSP-101, to treat Bronchiolitis Obliterans (BO).

Roche’s Xolair gets FDA breakthrough status for food allergies

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.

FDA approves Alnylam’s Onpattro to treat polyneuropathy of hATTR amyloidosis

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.

BioCryst’s HAE drug BCX7353 gets FDA fast track designation

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).

EMA grants orphan designation to selumetinib to treat neurofibromatosis type 1

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).

Pfizer secures European approval for Xeljanz to treat ulcerative colitis

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).

Progenics’ Azedra gets FDA approval for rare adrenal gland tumors

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).

FDA approves Perseris for extended-release injectable suspension to treat schizophrenia in adults

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.

Agios Pharmaceuticals secures FDA nod for leukemia treatment Tibsovo

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.