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eosinophilic

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FDA approves Apellis’ Empaveli for rare blood disease

PEGASUS study results show Empaveli is better than Soliris at improving haemoglobin levels

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EMA introduces new measures to enable flexibility for non-COVID-19 procedures

Regulator will streamline processes to allow its experts to focus on COVID-19-related assessments

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New court filing alleges Sanofi destroyed emails relating to Zantac recall

Drugmaker began recalling heartburn drug in 2019 after link to probable human carcinogen

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AZ, Amgen file first-in-class asthma drug with the FDA

Submission is based on positive results from the companies’ PATHFINDER clinical programme

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Emergency authorisation for Pfizer/BioNTech vaccine expanded in the US

Data from a study involving 12 to 15 year olds has also been submitted to the EMA for potential approval

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Pfizer, BioNTech file for full US approval of COVID-19 vaccine

Pfizer chief executive Albert Bourla said last week the company is on track to supply 2.7bn doses in 2021

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FDA approval for Keytruda/Herceptin combination in first-line advanced gastric cancer

Approval is based on positive overall response rate (ORR) data from KEYNOTE-811 trial

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J&J resumes US rollout of single-dose COVID-19 vaccine

CDC and FDA recommended pause be lifted after ‘rigorous review’ of very rare blood clots

- PMLiVE

GSK wins approval for anti-PD-1 antibody Jemperli in endometrial cancer

AnaptysBio earns a $20m milestone payment on approval after originally developing the drug

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J&J halts manufacturing of COVID-19 at US plant after FDA warning

Inspection report found facility was “not maintained in a clean and sanitary condition”

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FDA approves new self-injection administration for Xolair

Drug is approved for asthma and other allergic and inflammatory conditions

- PMLiVE

UPDATE: US pauses rollout of J&J’s COVID-19 vaccine amid reports of rare blood clots

An advisory committee to the CDC recommended extending the pause in the US to review additional data

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