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- PMLiVE

Merck shares positive results for Keytruda in phase 3 bladder cancer study

Over 82,000 people in the US will be be diagnosed with bladder cancer in 2023

- PMLiVE

Merck shares positive late-stage results for Welireg in advanced kidney cancer

Renal cell carcinoma accounts for approximately 90% of kidney cancer diagnoses

- PMLiVE

Merck granted positive CHMP opinion for Keytruda combination in gastric cancer

Over one million new cases of gastric cancer were diagnosed globally in 2020

- PMLiVE

bluebird bio sells second FDA priority review voucher for $95m

The company sold its first voucher to Dutch biotech Argenx for $102m

- PMLiVE

FDA approves Ferring’s Adstiladrin as first gene therapy for bladder cancer

Non-muscle-invasive bladder cancer represents around 75% of all new bladder cancer cases

- PMLiVE

Roche’s COVID-19 antibody receives FDA approval for hospitalised adults

The decision makes Actemra the first FDA-approved monoclonal antibody to treat COVID-19

- PMLiVE

FDA lifts partial clinical hold on bluebird bio’s sickle cell gene therapy studies

The company can now resume the enrolment and treatment of patients aged two to 17 years

- PMLiVE

FDA approves updated COVID-19 boosters for children aged from six months

The Moderna and Pfizer/BioNTech boosters both target the BA.4/BA.5 omicron subvariants

- PMLiVE

Pfizer’s RSV vaccine candidate accepted for FDA priority review for use in older adults

A phase 3 study showed the vaccine was 85.7% effective in those with three or more symptoms

- PMLiVE

Pfizer/BioNTech submit FDA application for BA.4/BA.5 COVID-19 vaccine in children under five

The vaccine is already authorised as a booster for ages five years and older in the US and EU

- PMLiVE

FDA approves Rigel’s Rezlidhia for acute myeloid leukaemia

Phase 2 data showed a complete remission rate of 35% and median duration of 25.9 months

- PMLiVE

FDA approves Scynexis’ Brexafemme for recurrent vulvovaginal candidiasis

The antifungal is already approved in the US for vulvovaginal candidiasis

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