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Invivyd working with FDA towards potential Biologics License Application for COVID-19

The company plans head-to-head safety evaluation with COVID-19 vaccine, pending regulatory alignment

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FDA approves Teva’s Ajovy to prevent episodic migraine in paediatric patients

One in ten children and adolescents in the US are affected by the neurological condition

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Boehringer’s Hernexeos granted FDA accelerated approval for lung cancer patients

Approximately 226,650 lung cancer cases are expected to be diagnosed in the US this year

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FDA approves Celltrion’s Actemra biosimilar Avtozma for cytokine release syndrome

Avtozma IV now fully aligns with all indications covered by Actemra IV in the US

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FDA approves Jazz Pharmaceuticals’ Modeyso as first drug for ultra-rare brain cancer

H3 K27M-mutant diffuse midline glioma affects an estimated 2,000 people in the US every year

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Sanofi’s multiple myeloma candidate granted FDA orphan drug designation

More than 180,000 people worldwide are diagnosed with the disease every year

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Gilead Sciences’ Biktarvy granted FDA approval for expanded HIV use

An estimated 1.2 million people in the US are currently living with the virus

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BMS granted FDA priority review for Breyanzi in marginal zone lymphoma

The disease accounts for approximately 7% of all non-Hodgkin lymphoma cases

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FDA approves PTC Therapeutics’ Sephience to treat rare metabolic disorder PKU

Phenylketonuria affects one in every 13,500 to 19,000 newborns in the US

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FDA unveils PreCheck programme to enhance US domestic pharma supply chain

The new initiative was developed in response to President Donald Trump's executive order

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FDA grants fast track designation to Nektar’s rezpegaldesleukin in alopecia areata

Approximately 700,000 people in the US currently have some form of the autoimmune disease

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AstraZeneca’s Imfinzi granted FDA priority review to treat early-stage gastric cancer

Gastric cancer is the fifth leading cause of cancer-related deaths globally

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