|Alk-Abello A/S, of Hørsholm, Denmark||Standardized allergen extract, white birch (betula verrucosa) sublingual tablet||Allergy desensitization vaccine||Seasonal allergic rhinitis||Health Canada approved once-daily sublingual allergy immunotherapy, branded Itulatek, to treat tree pollen allergy|
|Bayer AG, of Leverkusen, Germany||Vitrakvi (larotrectinib)||Tyrosine receptor kinase (TRK) inhibitor||Advanced solid tumors||NICE recommended approval to treat advanced neurotrophic TRK fusion-positive tumors in adults and children if disease is locally advanced, metastatic or surgery could cause severe health problems and patients have no satisfactory treatment options|
|Beigene Ltd., of Beijing||Tislelizumab||PD-1 inhibitor||Non-small-cell lung cancer||China NMPA's Center for Drug Evaluation accepted sNDA filing to treat, in combination with chemotherapy regimens, first-line advanced squamous disease|
|Boehringer Ingelheim GmbH, of Ingelheim, Germany||Ofev (nintedanib)||Tyrosine kinase inhibitor||Systemic sclerosis-associated interstitial lung disease||EC approved drug to treat adult patients|
|Hope Biosciences Inc., of Houston||HB-adMSCs||Adipose-derived mesenchymal stem cell therapy||COVID-19 infection||FDA approved phase II study expected to enroll 110 hospitalized participants into 2 arms; those taking and those not taking hydroxychloroquine and azithromycin will be randomized into separate placebo or treatment groups, in addition to standard of care; those treated will receive 4 doses of 100 million HB-adMSCs over 10-day period|
|Myovant Sciences Ltd., of Basel, Switzerland||Relugolix||GNRH receptor antagonist||Advanced prostate cancer||Submitted NDA to FDA for once-daily oral (120 mg) drug|
|Passage Bio Inc., of Philadelphia||PBGM-01||GLB1 gene stimulator||Infantile GM1 gangliosidosis||FDA granted orphan drug designation|
For more information about individual companies and/or products, see Cortellis.