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- PMLiVE

priority review

- PMLiVE

Ipsen’s Onivyde regimen granted FDA approval to treat pancreatic cancer

Around 60,000 people are diagnosed with pancreatic adenocarcinoma in the US every year

- PMLiVE

GSK’s RSV vaccine granted FDA priority review for use in adults aged 50 to 59 years

Arexvy has already been approved in the US and Europe to protect those aged 60 years and older

- PMLiVE

GSK shares positive results for Blenrep combination in head-to-head multiple myeloma study

Approximately 176,000 new cases of multiple myeloma are diagnosed globally each year

- PMLiVE

Valneva sells FDA priority review voucher for chikungunya vaccine for $103m

The company received a tropical disease PRV in November following the FDA’s approval of Ixchiq for the prevention of disease caused by chikungunya virus

- PMLiVE

GSK’s Omjjara approved by MHRA to treat myelofibrosis patients with anaemia

The rare blood cancer affects approximately one in every 500,000 people worldwide

- PMLiVE

FDA publishes final industry guidance for CAR-T and gene therapies

The new guidance can also be applied to other genetically modified lymphocyte products, including  CAR NK cells

- PMLiVE

GSK partners with DNA specialist Elegen to advance medicines and vaccines

GSK will leverage Elegen’s cell-free synthetic DNA production technology

- PMLiVE

GSK’s Omjjara approved by EC to treat myelofibrosis patients with anaemia

About 40% of myelofibrosis patients have moderate-to-severe anaemia at the time of diagnosis

- PMLiVE

Sanofi/Regeneron’s Dupixent approved by FDA for younger eosinophilic oesophagitis patients

Around 21,000 children aged under 12 years in the US are being treated for the inflammatory disease

- PMLiVE

Johnson & Johnson’s bladder cancer drug Balversa granted full FDA approval

Urothelial carcinoma accounts for approximately 90% of bladder cancer cases

- PMLiVE

FDA grants fast track designation to Nurix’s BTK degrader for non-Hodgkin lymphomas

CLL is one of the most common types of leukaemia in adults, with around 18,740 new cases in the US last year

- PMLiVE

Takeda’s HyQvia granted FDA approval to treat rare neuromuscular disorder CIDP

Approximately five to seven people per 100,000 in the US are affected by the disorder

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