Reneo Pharmaceuticals, a clinical stage pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the company's lead drug candidate, REN001, for the treatment of fatty acid oxidation disorders (FAOD).
Merck has secured approval from the US Food and Drug Administration (FDA) for Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) to treat appropriate adults living with HIV-1 who are virologically suppressed.
SanBio has secured regenerative medicine advanced therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its SB623 cell therapy to treat chronic neurological motor deficits secondary to traumatic brain injury (TBI).
Roche has secured a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its Gazyva (obinutuzumab) to treat adults with lupus nephritis.
Merck and Eisai have announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) plus Lenvima (lenvatinib) to treat patients with certain types of endometrial carcinoma.
CTD Holdings, a clinical stage biotechnology company that develops cyclodextrin-based products for the treatment of disease with unmet medical need, announced that the company will provide Trappsol Cyclo, its proprietary hydroxypropyl beta cyclodextrin drug, to a pediatric patient diagnosed with Niemann-Pick Disease Type C.
GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Nucala (mepolizumab) to treat children as young as six years old living with severe eosinophilic asthma.
The US Food and Drug Administration (FDA) has approved Xeris Pharmaceuticals’ GVOKE (glucagon) injection for the treatment of severe hypoglycaemia in paediatric and adult patients having diabetes, aged two years and above.
Acceleron Pharma, a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).
Boehringer Ingelheim Pharmaceuticals has secured approval for Ofev (nintedanib) capsules from the US Food and Drug Administration (FDA) for the treatment of interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD).
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