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FDA restricts use of certain antibody treatments for COVID-19

The restrictions reflect recent data that shows these antibodies are not effective against the Omicron variant

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FDA grants priority review for Roche’s Evrysdi for spinal muscular atrophy in babies

The review of Evrysdi has been developed for pre-symptomatic babies under two months old with spinal muscular atrophy

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Gilead’s Veklury receives FDA approval for non-hospitalised high-risk patients to treat COVID-19

The FDA also issued an EUA for the treatment to include non-hospitalised paediatric patients 12 years and under who are at high risk of disease progression

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AstraZeneca’s Enhertu receives FDA grant for priority review

The approval is based on results from the DESTINY-Breast03 trial which showed a significant risk reduction of unresectable or metastatic HER-2 positive breast cancer progression

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Pfizer’s Cibinqo granted FDA approval for adults with moderate-to-severe atopic dermatitis

The FDA based its approval on results from a clinical trial programme involving over 1,600 patients

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Pfizer expands access to lipid nanoparticle technology in new agreement with Acuitas Therapeutics

Acuitas’ LNP technology is already used in the Pfizer/BioNTech COVID-19 vaccine, Comirnaty

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Amgen’s Lumykras receives conditional marketing authorisation from EC

The drug is the first targeted therapy for patients diagnosed with advanced NSCLC with the KRAS G12C mutation

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Pfizer/BioNTech confirm new global collaboration to develop first mRNA-based shingles vaccine

The companies plan to begin clinical trials of the new vaccine in the second half of 2022

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Pfizer/BioNTech receives expanded authorisation from the FDA for its COVID-19 booster

The booster dose of the companies’ COVID-19 vaccine is now authorised to include individuals aged 12 years and older

The Ongoing Evaluation of Medical Affairs

Eddie Power, Vice President of North America Medical Affairs, Hospital Business at Pfizer, discusses a range of topics, including the effects of COVID-19 on the way Medical Affairs teams work...

Impetus Digital

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FDA rejects Takeda’s Eohilia after delays

After more than a year on ‘priority review’, the FDA has said it cannot approve Takeda’s budesonide oral suspension without a further clinical study

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FDA approves Amgen’s Otezla for all patients with plaque psoriasis

The FDA has expanded use of Otezla to adults with mild to moderate plaque psoriasis, making it the first oral treatment for the skin condition, regardless of severity

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