FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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AbbVie provides update on Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis in the U.S.

3 December 2021 - AbbVie today announced an update to the U.S. Prescribing Information and Medication Guide for Rinvoq (upadacitinib) for ...

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FDA approves pembrolizumab for adjuvant treatment of stage IIB or IIC melanoma

3 December 2021 - On 3 December 2021, the FDA approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of adult ...

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ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic

3 December 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation have reviewed some of ...

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FDA approves rituximab plus chemotherapy for paediatric cancer indications

3 December 2021 - On 2 December 2021, the FDA approved rituximab (Rituxan, Genentech) in combination with chemotherapy for pediatric ...

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Agenda for the December 2021 PBAC intracycle meeting

3 December 2021 - The agenda for the December 2021 PBAC intracycle meeting is now available. ...

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TOT Biopharm announces NMPA granted marketing approval for Pusintin (TAB008, bevacizumab) in China

1 December 2021 - TOT Biopharm announced its self-developed Pusintin (TAB008, bevacizumab) has been officially granted approval by the National ...

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ZetaMet receives breakthrough device designation from U.S. FDA for treatment of metastatic bone cancers

1 December 2021 - The technology is a first of its kind molecular pathway designed to suspend cancer, inhibit pain, and ...

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ATAGI update following weekly COVID-19 meeting (1 December 2021)

3 December 2021 - On  1 December 2021 ATAGI reviewed the latest developments relating to COVID-19 and COVID-19 vaccine safety.  ...

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MHRA grants conditional marketing authorisation for COVID-19 treatment Xevudy (sotrovimab)

2 December 2021 - A supply agreement reached with UK government will enable access to sotrovimab for UK patients. ...

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Harmonisation of health technology assessment across the European Union: lessons for the United States

2 December 2021 - In the multi-payer US system, each public program, private insurer, and self-insured employer conducts its own ...

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PHARMAC in review (2021) - part 2

3 December 2021 - As expected, the interim report fails to address the elephant in the room. ...

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Call for a central portal for clinical study reports

1 December 2021 - In an open-access publication in the Journal of European CME, two authors from IQWiG argue that ...

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Investors say drug pricing measure may shift incentives for biotech venture funding

2 December 2021 - Some analysts say bill would discourage investment in drugs taken as pills. ...

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EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)

2 December 2021 - The EMA’s CHMP has started a rolling review of VLA2001, a COVID-19 vaccine being developed by ...

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Strengthening patient access to new medicines through new landmark Bill

2 December 2021 - Australians will see improved access to new and innovative medicines, vaccines and treatments as a landmark ...

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