FDA approves first faecal microbiota product

30 November 2022 - Today, the US FDA approved Rebyota, the first faecal microbiota product approved by the agency.  ...

Read more →

Orchard Therapeutics announces Swissmedic validation of the marketing authorisation application for Libmeldy (atidarsagene autotemcel)

1 December 2022 - Orchard Therapeutics today announced its marketing authorisation application for Libmeldy (atidarsagene autotemcel) has been accepted for ...

Read more →

European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...

Read more →

AbbVie announces provincial reimbursement for Rinvoq (upadacitinib) for the treatment of rheumatoid arthritis and psoriatic arthritis in Alberta, New Brunswick, Ontario, Quebec and Saskatchewan

1 December 2022 - AbbVie today announced that Rinvoq is now listed as a special authorisation medication or exception medication status ...

Read more →

Hopes $55k breast cancer drug Keytruda will get PBS listing

3 December 2022 - Women with triple negative breast cancer have been given new hope that immunotherapy drug Keytruda will ...

Read more →

EQRx announces acceptance of marketing authorisation application by the European Medicines Agency for aumolertinib in EGFR mutated non-small-cell lung cancer

2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...

Read more →

COVID-19 vaccine safety report (1 December 2022)

1 December 2022 - To 27 November 2022, the TGA has received 709 reports which have been assessed as likely to ...

Read more →

FDA approves olutasidenib for relapsed or refractory acute myeloid leukaemia with a susceptible IDH1 mutation

1 December 2022 - Today, the FDA approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid ...

Read more →

Tezepelumab for the treatment of patients with severe asthma

2 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...

Read more →

Y-mAbs announces complete response letter for omburtamab biologics license application

1 December 2022 - Y-mAbs Therapeutics today announced that the US FDA has issued a complete response letter for the ...

Read more →

Agenda for the December 2022 PBAC intracycle meeting

2 December 2022 - The agenda for the December 2022 PBAC intracycle meeting is now available. ...

Read more →

Afraid of pharma pushback, a health data broker puts up a barrier to drug pricing information

1 December 2022 - At a time when many Americans are clamouring for more transparency into prescription drug pricing, one ...

Read more →

Early breast cancer: indication of a minor additional clinical benefit of adjuvant therapy with olaparib

1 December 2022 - Adjuvant treatment with olaparib can prolong life and prevent recurrence in early breast cancer. However, it ...

Read more →

‘Good news’ for Kiwi women as PHARMAC funds Utrogestan from today

1 December 2022 - The end of a decade long wait. ...

Read more →

Livtencity (maribavir) receives positive CADTH recommendation for adults with post-transplant cytomegalovirus infection

1 December 2022 - The conditions for the positive recommendation is supported by the findings of the Phase 3 SOLSTICE ...

Read more →

Takeda Korea's Kynteles SC wins insurance benefit

1 December 2022 - Takeda Pharmaceuticals Korea said Kynteles SC, an inflammatory bowel disease treatment, started to be covered by ...

Read more →