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regulatory approval

FDA looks at pulling speedy approvals for three cancer drugs

FDA looks at pulling speedy approvals for three cancer drugs

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see

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FDA looks at pulling speedy approvals for three cancer drugs

https://pharmaphorum.com/news/fda-looks-at-pulling-speedy-approvals-for-three-cancer-drugs/

MHRA approves Seagen’s oral HER2 drug Tukysa

MHRA approves Seagen’s oral HER2 drug Tukysa

The UK drugs regulator has approved Seagen’s Tukysa as a third-line treatment for HER2-positive breast cancer, shortly after

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MHRA approves Seagen’s oral HER2 drug Tukysa

https://pharmaphorum.com/news/mhra-approves-seagens-oral-her2-drug-tukysa/

Sobi gets EU nod for Doptelet in rare blood disorder ITP

Sobi gets EU nod for Doptelet in rare blood disorder ITP

Sweden’s Sobi has secured EU approval for Doptelet in primary chronic immune thrombocytopenia (ITP), an indication that the

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Sobi gets EU nod for Doptelet in rare blood disorder ITP

https://pharmaphorum.com/news/sobi-gets-eu-nod-for-doptelet-in-rare-blood-disorder-itp/

Roche claims EU okay for Herceptin/Perjeta combination Phesgo

Roche claims EU okay for Herceptin/Perjeta combination Phesgo

Roche has secured EU approval for Phesgo, a fixed-dose combination of its breast cancer drugs Herceptin and Perjeta

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Roche claims EU okay for Herceptin/Perjeta combination Phesgo

https://pharmaphorum.com/news/roches-claims-eu-okay-for-herceptin-perjeta-combination-phesgo/

Vertex gets EU okay to treat younger cystic fibrosis patients

Vertex gets EU okay to treat younger cystic fibrosis patients

A new EMA approval has expanded the use of Vertex Pharma’s exon-skipping cystic fibrosis therapy Symkevi to children

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Vertex gets EU okay to treat younger cystic fibrosis patients

https://pharmaphorum.com/news/vertex-gets-eu-okay-to-treat-younger-cystic-fibrosis-patients/

GSK moves further ahead in BCMA with EU okay for Blenrep

GSK moves further ahead in BCMA with EU okay for Blenrep

GlaxoSmithKline has approval on both sides of the Atlantic for its multiple myeloma drug Blenrep, after getting the

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GSK moves further ahead in BCMA with EU okay for Blenrep

https://pharmaphorum.com/news/gsk-moves-further-ahead-in-bcma-with-eu-okay-for-blenrep/

Regulatory timelines in the Asia-Pacific

Regulatory timelines in the Asia-Pacific

Snapshot of clinical trial application processes in the region.

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Regulatory timelines in the Asia-Pacific

https://pharmaphorum.com/views-and-analysis/regulatory-timelines-asia-pacific/

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