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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 […]

India approves Serum Institute’s Covishield and Bharat Biotech’s Covaxin vaccines

The Drugs Controller General of India (DCGI) has granted emergency approvals to Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin vaccines for the prevention of Covid-19. COVISHIELD has been developed at the Serum Institute of India’s laboratory in Pune with a master seed from Oxford University and pharma giant AstraZeneca. According to DCGI VG […]

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Swissmedic authorizes use of BNT162b2 Covid-19 vaccine from Pfizer, BioNTech

Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the use of the BNT162b2 Covid-19 vaccine from US pharma giant Pfizer and German biotech company BioNTech. The Swiss pharma regulator said that as per the data it has assessed, the level of protection afforded seven days following the second dose of the mRNA vaccine is […]

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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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PTC Therapeutics wins Russian approval for Translarna for nmDMD

US-based PTC Therapeutics has secured marketing approval in Russia for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). The approval for Translarna has been given by the Ministry of Health of the Russian Federation for Duchenne muscular dystrophy caused by a nonsense mutation in patients, aged two years and older. Stuart […]

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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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UK authorizes Pfizer and BioNTech’s BNT162b2 Covid-19 vaccine

The UK has given a temporary authorization for emergency use for the BNT162b2 Covid-19 vaccine candidate developed by Pfizer and BioNTech. The emergency use authorization (EUA) from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for the mRNA vaccine candidate follows the release of positive results of a global phase 3 trial. Pfizer and […]

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