DARZALEX FASPRO FDA approval for AL amyloidosis : Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has secured approval from the US Food and Drug Administration (FDA) for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) for the treatment of light chain (AL) amyloidosis, which has been newly diagnosed in […]
AstraZeneca has secured extended approval from the US Food and Drug Administration for using Tagrisso (osimertinib) as an adjuvant treatment of non-small cell lung cancer (NSCLC) in patients whose tumors have a certain type of genetic mutation. According to the FDA, nearly 20% of patients with non-small cell lung cancer will have epidermal growth factor […]
Continue reading …Moderna Covid-19 vaccine : The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for mRNA-1273, the messenger RNA (mRNA) Covid-19 vaccine candidate of Moderna. The FDA authorization is for the use of mRNA-1273 in individuals aged 18 years and more for the prevention of Covid-19 caused by severe acute respiratory syndrome […]
Continue reading …BNT162b2 FDA EUA : Pfizer and BioNTech have been granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for BNT162b2, their Covid-19 mRNA vaccine. BNT162b2 has been authorized by the FDA for its use in the prevention of Covid-19 in individuals aged 16 years or more. Pfizer and BioNTech will look […]
Continue reading …Alligator Bioscience said that the investigational new drug application for its CD40 targeting antibody mitazalimab has been approved by the US Food and Drug Administration (FDA). The IND approval enables the Swedish biotech company to begin clinical trials for mitazalimab in the US. According to Alligator Bioscience, a new benchmark data was recently published which […]
Continue reading …Eli Lilly and Company (Lilly) has entered into a partnership with managed care company UnitedHealth Group to carry out a pragmatic study of bamlanivimab (LY-CoV555) in high-risk, Covid-19 infected individuals. Recently, bamlanivimab was granted emergency use authorization (EUA) from the US Food and Drug Administration for the treatment of Covid-19 patients having mild to moderate […]
Continue reading …Novo Nordisk has been given approval from the US Food and Drug Administration (FDA) for an updated label for Saxenda (liraglutide) injection 3 mg for obesity treatment in adolescents in the 12–17 years age group. The approval is for adolescents who weigh more than 60 kg and have an initial body mass index (BMI) corresponding […]
Continue reading …Pegunigalsidase alfa (PRX–102) update : Protalix BioTherapeutics said that the US Food and Drug Administration (FDA) has extended the prescription drug user fee act (PDUFA) date for review of pegunigalsidase alfa (PRX–102) as a treatment of adults with Fabry disease. The PDUFA action date for reviewing the company’s biologics license application (BLA) has been extended […]
Continue reading …V114 pneumococcal conjugate vaccine candidate : Merck has submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for V114, its 15-valent pneumococcal conjugate vaccine candidate. The Merck vaccine candidate is intended for use in adults 18 years of age and older. The pharma giant said that it […]
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