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.
AstraZeneca and Merck have secured approval from the European Union (EU) for the Lynparza as a maintenance treatment for adult patients with germline BRCA-mutated metastatic pancreatic cancer.
Neurogene, a company founded with a mission to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced that the US Food and Drug Administration (FDA) granted Orphan Drug Designation to adeno-associated virus vector with engineered transgene encoding the human CLN5 gene for patients with CLN5, a form of Batten disease.
Gilead Sciences has secured conditional marketing authorisation from the European Commission for its Veklury (remdesivir) to treat SARS-CoV-2 infection, which is responsible for the Covid-19 disease.
Specialist HIV company ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Rukobia (fostemsavir) 600mg extended-release tablets to treat HIV in adult patients.
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