COVID-19: EMA recommends conditional marketing authorisation for Paxlovid

27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...

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Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory DLBCL, PMBCL and FL3B

28 January 2022 - Recommendation for approval based on results from TRANSCEND NHL 001, the largest pivotal trial of patients ...

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Glaucoma drug Vyzulta, psoriasis remedy Skilarence win insurance benefit

28 January 2022 - The government granted health insurance benefits for Bausch Health Korea’s glaucoma treatment Vyzulta (latanoprostene bunod) and ...

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Updates on Olumiant (baricitinib) FDA review for atopic dermatitis

28 January 2022 - Eli Lilly and Incyte today announced updates on the Phase 3 development program for Olumiant (baricitinib) in ...

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Regeneron and Sanofi provide regulatory update on Libtayo (cemiplimab-rwlc) in advanced cervical cancer

28 January 2022 - Regeneron Pharmaceuticals and Sanofi today announced the voluntary withdrawal of the supplemental biologics license application for Libtayo ...

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Highlights from CHMP 24-27 January meeting

28 January 2022 - EMA’s CHMP recommended seven medicines for approval at its January 2022 meeting. ...

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Recommendations made by the PBAC – December 2021 intracycle meeting

28 January 2022 - Recommendations made by the PBAC in December 2021 relating to the listing of drugs on the PBS ...

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'I feel like I'm drowning': thousands with cystic fibrosis wait to hear if 'life-saving' drug will be listed on PBS

27 January 2022 - Matt Dickinson was struggling to breathe when his mother rushed him to an Adelaide hospital earlier ...

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Australians deserve fast access to the latest medicines, vaccines and treatments

28 January 2022 - Medicines Australia recommends the Australian Government delivers a plan to shorten the time that patients wait ...

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Pfizer's COVID-19 vaccine (Comirnaty) provisionally approved for use as a booster in individuals aged 16-17 years old

28 January 2022 - The Therapeutic Goods Administration has provisionally approved the Pfizer COVID-19 vaccine, Comirnaty for use as a ...

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Moderna aims to deliver Omicron COVID-19 vaccine by September

27 January 2022 - A COVID-19 booster shot, targeted specifically at the Omicron variant, is expected to be delivered by ...

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FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty

27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...

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The certainty of uncertainty in health technology assessment

26 January 2022 - History is replete with stories of poor decisions—catastrophes that leaders might have averted, and great opportunities that ...

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Positive Early Access to Medicines Scheme (EAMS) scientific opinion awarded to GBT’s voxelotor for the treatment of haemolytic anaemia due to sickle cell disease

27 January 2022 - Global Blood Therapeutics today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has awarded ...

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Shortage of prescription infant formula worries parents

28 January 2022 - A shortage of prescription infant formula has parents worried about how they will feed their babies. ...

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FDA grants breakthrough therapy designation for Dizal Pharmaceutical's DZD9008 in patients with locally advanced or metastatic non-small cell lung cancer harbouring EGFR Exon 20 insertion

27 January 2022 - Breakthrough therapy designation further demonstrates excellent clinical profile of DZD9008 (sunvozertinib). ...

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