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FDA Approval of Whooping Cough Vaccine for Infants Less Than 2 Months of Age

Digital Pharmacist

On October 7 th , 2022 the U.S. Children aged 2 months of age or younger are not eligible for the Tdap vaccine. The lack of solid data around the effectiveness and safety of the Tdap vaccine on the newborn itself was what led to further research. The FDA considered the safety data with the non-U.S. Background of Boostrix.

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ACIP Unanimously Recommends Use of Pneumococcal 15-Valent Conjugate Vaccine for Infants and Children

Pharmacy Times

Vaxneuvance was approved for an expanded indication by the FDA on June 22, 2022, for active immunization in children 6 weeks of age and older.

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FDA pulls AZ’s Evusheld for COVID, citing lack of efficacy

pharmaphorum

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. and other XBB subvariants, said the FDA in an update. Evusheld is also ineffective against the BQ.1,

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Personalised cancer immunotherapy granted fast track designation

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Evaxion Biotech’s personalised cancer immunotherapy. EVX-01 cancer immunotherapy EVX-01 is a peptide-based cancer immunotherapy generated based on gene analysis of a patient’s tumours and on matching with their immune system. Moderna, Inc.

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Zydus gets FDA approval for antibiotic drug azithromycin

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted final approval to India-based Zydus Lifesciences ‘ 500mg azithromycin tablets for the treatment of bacterial infections. The company began supplying the first consignment to the government of India in February 2022.

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Monkeypox vaccine: First EUA for Bavarian Nordic amid worldwide shortages

Pharmaceutical Technology

Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On the same day, the FDA granted a EUA to Bavarian Nordic’s (Copenhagen, Denmark) Jynneos vaccine.

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FDA authorises COVID-19 booster jabs for at-risk people

pharmaphorum

The FDA has cleared the use of third dose of either the Pfizer/BioNTech or Moderna COVID-19 vaccines for people with weakened immune systems, but stopped short of recommending a broader booster campaign. The US hit its target of 70% of adults being fully vaccinated earlier this month.

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