FDA caught up on domestic pre-approval inspections, foreign inspections still a challenge

20 June 2022 - The US FDA eliminated its backlog of overdue domestic pre-approval inspections, yet such progress has been ...

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BeiGene announces PDUFA goal date extension for U.S. sNDA for Brukinsa for the treatment of CLL/SLL

13 June 2022 - Following additional data submission to FDA demonstrating ORR superiority over ibrutinib as determined by IRC, PDUFA goal ...

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FDA approves new oncology drugs quicker than EMA

10 June 2022 - The US FDA is quicker to approve new oncology drugs compared with the EMA, according to ...

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Response to engagement on proposals for the Innovative Medicines Fund

7 June 2022 - NHS England and NICE asked for comments on our proposals for the Innovative Medicines Fund.  ...

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Patients to have earlier access to cutting edge treatments on NHS

7 June 2022 - The most promising medicines will be fast-tracked to NHS patients through Innovative Medicines Fund ...

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Amylyx Pharmaceuticals receives notification of PDUFA date extension for AMX0035 for the treatment of ALS

3 June 2022 - New PDUFA goal date scheduled for 29 September 2022 to allow time to review additional data ...

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argenx announces the UK MHRA has granted early access to efgartigimod for generalised myasthenia gravis

31 May 2022 - Efgartigimod was granted a promising innovative medicine designation by UK’s MHRA in November 2021. ...

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TG Therapeutics announces FDA extension of BLA PDUFA date for ublituximab to treat patients with RMS

31 May 2022 - New PDUFA goal date of 28 December 2022. ...

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Patients deserve immediate access to FDA approved innovations — not bureaucratic restrictions

21 May 2022 - Innovation is the lifeblood that has made America the most economically successful nation in the modern era. ...

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Amicus Therapeutics receives notification of PDUFA date extensions for AT-GAA

10 May 2022 - Amicus Therapeutics today announced that the U.S. FDA has extended the review period by 90 days ...

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Making #MedicinesMatter for all Australians

21 April 2022 - Medicines Australia has launched a social media campaign to highlight key policy issues for the election ...

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U.S. FDA extends review of biologics license application for Regen-Cov (casivirimab and imdemivab) for treatment and prophylaxis of COVID-19

14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...

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Irish cancer patients wait four months longer for access to new drugs than rest of Europe

11 April 2022 - Cancer patients in Ireland are waiting on average four months longer than people with the disease ...

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Drug makers pledge speedier European market launches to avert stricter regulation

11 April 2022 - Drug makers on Monday pledged to speed up the market launch of new drugs in underserved ...

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Faster patient access to new medicines must be a priority for next Government

10 April 2022 - With the Federal Election campaign now formally underway, Medicines Australia is reminding the major parties of ...

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