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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

pharmaphorum

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. of participants.

Vaccines 111
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Allergic reactions prompt Moderna COVID vaccine pause in California

pharmaphorum

Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic. The clinic in question switched to another lot of Moderna vaccine after closing for a few hours.

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AZ, J&J COVID-19 vaccine trials okay to restart in US

pharmaphorum

US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot. There are many possible factors that could have caused the event.”.

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FDA approves first gene therapy for high-risk early bladder cancer

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours.

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First chikungunya vaccine approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Valneva SE’s IXCHIQ ® , the first chikungunya vaccine to be authorised in the world. The single-dose, live-attenuated vaccine is indicated for preventing chikungunya virus disease in individuals over 18 years old who are at increased risk of contracting the virus.

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Important information about Dupixent and vaccines

The Checkup by Singlecare

Its most common use is for the treatment of severe eczema (atopic dermatitis) in adults and children 6 months and older, but it’s also approved by the Food and Drug Administration (FDA) to treat asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, and eosinophilic esophagitis (EoE) in certain people.

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With filing due soon, Moderna stakes a claim to the RSV vaccine market

pharmaphorum

Moderna is looking to make a swift dash to the finish line with its respiratory syncytial virus (RSV) vaccine candidate, based on the same mRNA technology as its COVID-19 shots, with a filing in with the FDA in the first half of this year. for placebo.