Annexon Biosciences has secured fast track designation from the US Food and Drug Administration (FDA) for its novel C1q inhibitor, ANX005, to treat Guillain-Barré Syndrome (GBS).
EMD Serono, the biopharmaceutical business of Merck, and Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
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.
AstraZeneca’s Farxiga (dapagliflozin) has been granted fast track designation from the US Food and Drug Administration (FDA) for its use in reducing the risk of heart failure.
A committee of the US Food and Drug Administration (FDA) has voted in favour of the use of Aimmune Therapeutics’ AR101 for the treatment of peanut allergy in children and teens.
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.
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