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Novel immunotherapy approved for melanoma
The first non-CAR-T adoptive cell therapy to reach the market…
The first non-CAR-T adoptive cell therapy to reach the market has been approved by the US Food and Drug Administration (FDA).
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Dr Peter Marks
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Pfizer maternal RSV vaccine approved
The US Food and Drug Administration (FDA) has authorised an…
The US Food and Drug Administration (FDA) has authorised an RSV vaccine for pregnant individuals, which in one study, reduced the risk of severe LRTD by 81.8 percent within 90 days after birth.
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First gene therapy approved for Haemophilia A
The first approved gene therapy for haemophilia A reduced the…
The first approved gene therapy for haemophilia A reduced the mean annualised bleeding rate from 5.4 bleeds to 2.6 bleeds per year in a clinical study.
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First cell therapy approved for Type 1 diabetes
US Food and Drug Administration (FDA)-approved allogeneic pancreatic islet cell…
US Food and Drug Administration (FDA)-approved allogeneic pancreatic islet cell therapy Lantidra could provide another treatment option for Type 1 diabetes.
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FDA approves first gene therapy for high-risk early bladder cancer
The first gene therapy for high-risk non-muscle-invasive bladder cancer has…
The first gene therapy for high-risk non-muscle-invasive bladder cancer has been approved by The US Food and Drug Administration (FDA).
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First faecal microbiota product approved for C. diff
The first faecal microbiota product to prevent recurrence of Clostridioides…
The first faecal microbiota product to prevent recurrence of Clostridioides difficile infection in adults has been approved by the FDA.
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FDA approves first gene therapy for Haemophilia B
Hemgenix, the first gene therapy for adults with Haemophilia B…
Hemgenix, the first gene therapy for adults with Haemophilia B has been approved by the US Food and Drug Administration (FDA).
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First FDA pregnancy-approved Pertussis vaccine to protect newborns
The FDA has approved Boostrix, the first vaccine for pregnant…
The FDA has approved Boostrix, the first vaccine for pregnant women in their third trimester, to stop whooping cough (Pertussis) in infants below two months.
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Second COVID-19 vaccine ‘Spikevax’ is approved by the FDA
The FDA has approved a second vaccine, marketed as Spikevax,…
The FDA has approved a second vaccine, marketed as Spikevax, shown to be 93 percent effective in preventing COVID-19.
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FDA authorises Comirnaty® for emergency use in five to 11 year olds
The US Food and Drug Administration has authorised the emergency…
The US Food and Drug Administration has authorised the emergency use of COVID-19 vaccine Comirnaty in children aged five to 11 years.
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FDA authorises Comirnaty® booster dose for certain populations
The US FDA amended the emergency use authorisation to allow…
The US FDA amended the emergency use authorisation to allow for a Comirnaty booster dose in individuals at high-risk for COVID-19.
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-300x278.jpg)
![Gloved hand holding a vial labelled 'COVID-19 Vaccine' with Pfizer and BioNTech logos [Credit: malazzama / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Pfizer-BioNTech-COVID-19-vaccine-e1629795881701.jpg)
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Pfizer-BioNTech becomes the first FDA-approved COVID-19 vaccine
Pfizer and BioNTech's vaccine is the first to be approved…
Pfizer and BioNTech's vaccine is the first to be approved by the FDA for the prevention of COVID-19 in people aged 16 years and older.
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FDA allows Pfizer’s COVID-19 vaccine to be used in adolescents
The Comirnaty® vaccine’s emergency use authorisation has been extended to…
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
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US pauses administration of Janssen COVID-19 Vaccine
The FDA and CDC have decided to temporarily suspend use…
The FDA and CDC have decided to temporarily suspend use of Janssen’s single dose vaccine while reports of rare and severe blood clots are investigated.
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FDA approves Abecma, the first cell-based gene therapy for adults with multiple myeloma
Abecma (idecabtagene vicleucel) was approved for adults with relapsed or…
Abecma (idecabtagene vicleucel) was approved for adults with relapsed or refractory myeloma based on its 72 percent overall response rate in a trial.
