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- PMLiVE

FDA grants fast track designation to Candel’s immunotherapy in pancreatic cancer

The disease is the fourth leading cause of cancer-related death in the US, accounting for 3.3% of new cancer cases

- PMLiVE

FDA approves two cell-based gene therapies for sickle cell disease

Vertex/CRISPR and bluebird bio’s gene therapies have been approved to treat patients aged 12 years and older

- PMLiVE

Sanofi and AI specialist Aqemia enter $140m drug discovery partnership

The deal is aimed at discovering small molecule drugs across several therapeutic areas

- PMLiVE

Novartis’ Fabhalta approved by FDA as first oral monotherapy for rare blood disease PNH

The rare blood disease is estimated to affect only ten to 20 people per million worldwide

- PMLiVE

Eli Lilly’s Jaypirca granted FDA accelerated approval for non-Hodgkin lymphomas

Approximately 18,740 new cases of CLL have been diagnosed in the US this year

- PMLiVE

FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

The regulator will monitor approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies

- PMLiVE

FDA approves SpringWork’s Ogsiveo as first therapy for desmoid tumours

Approximately 1,650 people in the US are diagnosed with the rare non-cancerous tumours each year

- PMLiVE

Sanofi/Regeneron’s Dupixent shows promise in chronic obstructive pulmonary disease

About 300,000 people in the US have uncontrolled COPD and type 2 inflammation

- PMLiVE

Pfizer and Astellas’ Xtandi approved by FDA for earlier prostate cancer indication

Xtandi is the first androgen receptor signalling inhibitor approved for this patient population

- PMLiVE

Merck receives FDA approval for Keytruda combination in gastric cancer

An estimated 26,500 people in the US will be diagnosed with gastric cancer in 2023

- PMLiVE

AstraZeneca’s Truqap plus Faslodex receives FDA approval for advanced breast cancer

About 290,000 people in the US will be diagnosed with breast cancer in 2023

- PMLiVE

Bristol Myers Squibb’s lung cancer drug Augtyro receives FDA approval

The drug was added to BMS’ portfolio last year through its $4.1bn acquisition of Turning Point

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