regulatory approval

News

Mesoblast finally pushes GvHD cell therapy over finish line

At its third attempt, Mesoblast has secured FDA approval for the first-ever mesenchymal stem cell (MSC) therapy, Ryoncil for acute GvHD in children.

News

Lilly's Alzheimer's drug Kisunla is cleared in China

Eli Lilly has another approval for its anti-amyloid therapy for Alzheimer's disease, Kisunla, in China – the world's second-largest drugs market.

News

FDA clears Neurocrine drug for rare adrenal disorder

Neurocrine Bioscience's Crenessity is the first new option for classic congenital adrenal hyperplasia (CAH) in more than 70 years.

News

Galderma adds new indication for blockbuster hope Nemluvio

Galderma has claimed a second FDA approval for IL-31 inhibitor Nemluvio, adding atopic dermatitis to its label.

News

FDA clears AZ's Imfinzi for aggressive lung cancer

AstraZeneca's Imfinzi becomes the first cancer immunotherapy to be FDA-approved for limited-stage small cell lung cancer (LS-SCLC).

News

Merus grabs first-in-class US approval for NRG1 cancer drug

Merus has its first approval for a commercial product, getting the go-ahead from the FDA for Bizengri, a first-in-class therapy for cancer

Mesoblast finally pushes GvHD cell therapy over finish line

Lilly's Alzheimer's drug Kisunla is cleared in China

FDA clears Neurocrine drug for rare adrenal disorder

Galderma adds new indication for blockbuster hope Nemluvio

FDA clears AZ's Imfinzi for aggressive lung cancer

Merus grabs first-in-class US approval for NRG1 cancer drug

World Without Disease initiative: 2024 update

The AI effect in pharma commercial strategy: From data to re...

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