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Janssen secures DARZALEX FASPRO FDA approval for AL amyloidosis

Janssen secures DARZALEX FASPRO FDA approval for AL amyloidosis

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 gets FDA approval for Tagrisso for type of NSCLC

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 […]

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US FDA authorizes Moderna Covid-19 vaccine mRNA-1273

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 […]

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Pfizer and BioNTech secure FDA EUA for BNT162b2 Covid-19 vaccine

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 […]

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Alligator Bioscience gets FDA approval for IND application of mitazalimab

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 […]

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Bamlanivimab Covid-19 drug candidate : Lilly, UnitedHealth Group join forces for pragmatic study

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 […]

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Ensemble CMC Implant : Ensemble Orthopedics gets FDA 510(k) clearance

Ensemble Orthopedics has secured 510(k) clearance from the US Food and Drug Administration for its Ensemble CMC Implant for the treatment of patients with early-stage osteoarthritis of the carpometacarpal (CMC) joint. According to the Texas-based medical device company, the Ensemble CMC Implant has a saddle shape that replaces the natural bearing surfaces of the carpal […]

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Novo Nordisk gets Saxenda FDA updated label to cover obesity treatment in adolescents

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 […]

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FDA extends PDUFA for Pegunigalsidase alfa (PRX–102) in Fabry disease

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 […]

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Merck seeks FDA and EMA approvals for V114 pneumococcal conjugate vaccine candidate

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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