Zymeworks, a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab in patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC).
Vertex Pharmaceuticals has secured approval from the European Commission (EC) for Symkevi (tezacaftor/ivacaftor) plus Kalydeco (ivacaftor) for the treatment of elder children with cystic fibrosis (CF) aged between six and 11 years.
Astellas Pharma and FibroGen have announced the receipt of approval from the Japan’s Ministry of Health, Labour and Welfare (MHLW) for Evrenzo (roxadustat) to treat anaemia in adult patients suffering from chronic kidney disease (CKD) but not on dialysis.
Revance Therapeutics announced that the United States (U.S.) Food and Drug Administration (FDA) has deferred a decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, an investigational neuromodulator product for the treatment of moderate to severe glabellar (frown) lines.
Eli Lilly and Incyte have secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for baricitinib plus remdesivir to treat hospitalised patients with Covid-19.
Specialist HIV company ViiV Healthcare has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its long-acting and injectable cabotegravir to treat HIV pre-exposure prophylaxis (PrEP).
Amylyx Pharmaceuticals, a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to AMX0035 for the treatment of Wolfram syndrome.
Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda plus chemotherapy to treat patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 (combined positive score [CPS] ≥10) as determined by an FDA-approved test.
Forma Therapeutics has secured orphan drug status from the European Commission (EC) for its FT-4202 to treat sickle cell disease (SCD).
ImmunityBio, a privately-held immunotherapy company, and NantKwest, a clinical-stage, natural killer cell-based therapeutics company, today announced they have administered their second-generation bivalent, human adenovirus (hAd5) Covid-19 vaccine candidate in a Phase 1 trial with no serious adverse events (SAE) reported in the low dose cohort, safety is ongoing for the high dose cohort.
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