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buprenorphine

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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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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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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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US backs proposal to waive IP protection for COVID-19 vaccines

"Monumental decision" could see IP protections for COVID-19 vaccines temporarily removed

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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

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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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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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J&J’s MS drug ponesimod receives approval in the US

US regulator has approved the drug – now named Ponvory – for relapsing forms of MS

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FDA accepts BMS’ investigational cardiovascular drug mavacamten for review

BMS gained the rights to mavacamten as part of its acquisition of MyoKardia

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