regulatory approval

News

Menarini brings oral SERD to Europe with Orserdu okay

Menarini has secured EU approval for Orserdu, the first in a new class of oral selective oestrogen receptor degrader (SERD) drugs and the first innovation in endocrine the

News

EU has its first RoActemra biosimilar, from Fresenius Kabi

The European Commission has approved the first biosimilar version of Actemra/RoActemra, Roche’s $3 billion blockbuster, from German drugmaker Fresenius Kabi.

News

GSK gets wide FDA approval for myelofibrosis drug

GSK's cancer unit has been given a fillip by the FDA with a broader-than-expected approval for JAK inhibitor momelotinib for anaemia associated with myelofibrosis, acquire

News

FDA clears new Pfizer, Moderna COVID jabs as cases tick up

The FDA has authorised updated versions of Pfizer/BioNTech and Moderna's mRNA-based COVID-19 vaccines targeting the XBB.1.5 subvariant, in time for the start of a new autu

News

Keytruda gets front-line gastric cancer okay in EU

The European Commission has given approval to MSD's Keytruda as a first-line therapy for advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

News

GB first to approve Roche's subcutaneous Tecentriq

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has become the first regulator to approve Roche's subcutaneous (SC) formulation of cancer immunotherapy

Menarini brings oral SERD to Europe with Orserdu okay

EU has its first RoActemra biosimilar, from Fresenius Kabi

GSK gets wide FDA approval for myelofibrosis drug

FDA clears new Pfizer, Moderna COVID jabs as cases tick up

Keytruda gets front-line gastric cancer okay in EU

GB first to approve Roche's subcutaneous Tecentriq

Cancer Research UK earmarks £123m for Scottish R&D

Voices to Trials: Engaging Patients in Clinical Trial Design

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