FDA to allow ‘mix and match’ approach for Covid booster shots

18 October 2021 - The agency may act this week, when it is expected to authorise booster shots for recipients of ...

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Bringing a consumer perspective to clinical advice

19 October 2021 - PHARMAC is making changes to the way its advisory committees work to strengthen the input of ...

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CMS grants transitional pass through payment for Carlsmed's aprevo personalized interbody device

19 October 2021 - -Carlsmed announced today that CMS has granted aprevo a transitional pass through payment as part of the ...

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Akero Therapeutics receives FDA fast track designation for efruxifermin for the treatment of NASH

19 October 2021 - Akero Therapeutics today announced that the U.S. FDA has granted fast track designation to its lead program ...

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WHO led programme aims to buy antiviral COVID-19 pills for $10

19 October 2021 - A World Health Organization led programme to ensure poorer countries get fair access to COVID-19 vaccines, tests ...

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Strategies for generic/biosimilar market entry in Australia

19 October 2021 - After surviving the Great Patent Cliff of 2011–2016, the pharma/biopharma industry finds itself in the Second Great ...

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Dr. Reddy's Laboratories announces approval for lenalidomide capsules from the U.S. FDA

19 October 2021 - Dr. Reddy’s Laboratories today announced the final approval of its abbreviated new drug application for lenalidomide 2.5 ...

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New medicine for breast cancer approved by the TGA

19 October 2021 - Enhertu has been approved for provisional registration. ...

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Democrats’ drug pricing reforms aren’t what they seem

19 October 2021 - As part of their spending bill, Congressional Democrats are advancing legislation that'll empower Medicare to "negotiate" ...

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Health Canada receives submission from Pfizer-BioNTech to authorise the use of Comirnaty COVID-19 vaccine in children 5 to 11 years of age

18 October 2021 - Today, Health Canada received a submission from Pfizer-BioNTech seeking an authorisation for the use of its Comirnaty ...

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Avadel Pharmaceuticals announces ongoing FDA review of NDA for FT218 for patients with narcolepsy

15 October 2021 - Avadel Pharmaceuticals announced today that the U.S. FDA notified the company that the review of the new ...

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On COVID-19 booster shots, the FDA has overstepped its role

18 October 2021 - Booster shots for all adults six months after being vaccinated against COVID-19 are safe, effective, and ...

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Alnylam receives positive reimbursement recommendation from the CADTH for use of Givlaari for the treatment of acute hepatic porphyria in adults

18 October 2021 - Givlaari reduces chronic pain, improves quality of life and is the first and only therapy proven ...

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U.S. Food and Drug Administration approves expanded indication of Gilead’s Biktarvy for treatment of HIV-1 in paediatric populations

18 October 2021 - FDA approves low dose tablet for HIV treatment in virologically suppressed children weighing at least 14 kg. ...

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United Therapeutics provides an update on the progress of the Tyvaso DPI new drug application

18 October 2021 - Draft label contains both PAH and PH-ILD indications; no contra-indications and no boxed warning. ...

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