MYR Pharmaceuticals, a German biotechnology company focused on the development and commercialization of therapeutics for the treatment of chronic hepatitis B and D, is pleased to announce that the European Commission (EC) has granted the Conditional Marketing Authorization (CMA) for their lead compound HEPCLUDEX.
Clinical-stage biopharmaceutical company ReViral has secured fast track designation from the US Food and Drug Administration (FDA) for its sisunatovir to treat patients with serious respiratory syncytial virus (RSV) infection.
Roche announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines.
Novartis has secured approval from the European Commission (EC) for its Cosentyx (secukinumab) to treat moderate-to-severe plaque psoriasis in children and adolescents aged between six and 18 years.
Takeda Pharmaceutical has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational drug pevonedistat to treat patients with higher-risk myelodysplastic syndromes (HR-MDS).
Jazz Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution on July 21, 2020 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Boehringer Ingelheim has secured approval for a new indication of nintedanib to treat adults with other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF).
Janssen Pharmaceutical has secured approval from the US Food and Drug Administration (FDA) for Tremfya (guselkumab) for the treatment of active psoriatic arthritis (PsA) in adults.
Inflazome, the pioneering inflammasome biotech company developing multiple drugs that stop harmful inflammation, today announces that it has been granted orphan drug designation by the US Food and Drug Administration (FDA) for Inzomelid in the treatment of Cryopyrin-Associated Periodic Syndrome (CAPS).
Pfizer and Biopharmaceutical New Technologies (BioNTech) have secured fast track designation from the US Food and Drug Administration (FDA) for two investigational mRNA-based vaccine candidates against SARS-CoV-2, the novel coronavirus responsible for the Covid-19 disease.
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