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FDA says no to F2G’s novel antifungal

F2G’s attempt to end a two-decade drought in novel therapies for invasive fungal infections has hit a hurdle after the FDA said it was unable to approve its olorofim candi

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AZ may spin off its Chinese business, says report

AstraZeneca is looking at spinning out its Chinese operation and listing it in Hong Kong or Shanghai to insulate the business from rising geopolitical tension, according t

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FDA delays review of GSK’s momelotinib for myelofibrosis

GSK won’t be hearing from the FDA this month about its marketing application for momelotinib as a treatment for myelofibrosis patients with anaemia after all.

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Chasing AbbVie, Roche gets FDA OK for DLBCL bispecific

Roche has claimed FDA approval for its CD20xCD3 bispecific antibody Columvi as a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), setting up an

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Biosimilar uptake remains poor, but Sandoz has a plan

Sandoz is a major player in biosimilar medicines, so it’s no surprise that it is concerned about how slowly these drugs are making inroads against their brand-name equival

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Ipsen gets second FDA approval for itch drug Bylvay

It’s a case of so far, so good for Ipsen with its recent acquisition of Albireo, after the main asset in the deal – Bylvay – secured FDA approval for its second rare disea

FDA says no to F2G’s novel antifungal

AZ may spin off its Chinese business, says report

FDA delays review of GSK’s momelotinib for myelofibrosis

Chasing AbbVie, Roche gets FDA OK for DLBCL bispecific

Biosimilar uptake remains poor, but Sandoz has a plan

Ipsen gets second FDA approval for itch drug Bylvay

UK seeks views on indefinite CE marks for medical devices

How to meet your physicians where they are online

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