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- PMLiVE

Valneva’s chikungunya vaccine approved by FDA for adults at increased exposure risk

The decision makes Ixchiq, which is administered as a single injection, the world's first licensed vaccine against the mosquito-borne disease

- PMLiVE

Eli Lilly’s tirzepatide injection approved by MHRA and FDA for weight loss in adults

The drug has been authorised for use alongside a reduced-calorie diet and physical activity

- PMLiVE

MHRA authorises anastrozole to prevent breast cancer in post-menopausal women

The treatment could help prevent around 2,000 breast cancer cases in England

- PMLiVE

US FTC challenges more than 100 patents as ‘improperly listed’ with FDA

The agency has sent letters to ten companies including AbbVie, AstraZeneca and GSK

- PMLiVE

FDA grants fast track designation to AviadoBio’s dementia gene therapy

The regulator has also given clearance for the candidate to be studied in frontotemporal dementia patients

- PMLiVE

Eli Lilly exercises option to progress autoimmune and inflammatory disease therapy

The move triggers an undisclosed milestone payment to Lilly’s partner Sitryx Therapeutics

- PMLiVE

Merck’s Keytruda combination granted FDA approval for biliary tract cancer

Approximately 20,000 people are diagnosed with the disease each year in the US

- PMLiVE

Amgen’s Wezlana receives FDA approval to treat multiple inflammatory diseases

Wezlana is approved as a biosimilar referencing Janssen Pharmaceuticals’ Stelara

- PMLiVE

FDA completes meeting for potential genetic therapy to treat sickle cell disease

If approved, exa-cel will be the first genetic therapy available to treat patients with severe sickle cell disease

- PMLiVE

Novartis’ Cosentyx receives FDA approval for hidradenitis suppurativa

The decision makes Cosentyx the first biologic treatment approved for HS in nearly a decade

- PMLiVE

bluebird bio to sell FDA priority review voucher for $103m

The company previously sold its second voucher to Bristol Myers Squibb for $95m

- PMLiVE

FDA approves Santhera’s Duchenne muscular dystrophy drug Agamree

The rare muscle-wasting disorder is estimated to affect one in 3,500 male births worldwide

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