EMA to review Genmab, Pfizer’s MAA for tisotumab vedotin
Genmab and Pfizer’s marketing authorisation application (MAA) for Tisotumab vedotin, an antibody-drug conjugate (ADC) intended for the treatment…
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05 Feb 24
Genmab and Pfizer’s marketing authorisation application (MAA) for Tisotumab vedotin, an antibody-drug conjugate (ADC) intended for the treatment…
05 Feb 24
The approval was based on the positive outcomes of the ReSTORE Phase 3 clinical trial in which rezafungin…
02 Feb 24
Publicis Health has agreed to pay $350m to settle allegations made by all states and territories in the…
30 Jan 24
The approval was based on findings from an ADVANCE-CIDP 2 study in which the response rate was observed…
30 Jan 24
The approval was based on results from the Phase 3 MOMENTUM trial in which Omjjara met all its…
24 Jan 24
Zynrelef is a dual-acting local anaesthetic, created to provide a fixed-dose combination of the local anaesthetic bupivacaine and…
22 Jan 24
The approval was based on the positive findings from the pivotal, global ALPHA Phase 3 trial in which…
19 Jan 24
Zokinvy is indicated for Hutchinson-Gilford progeria syndrome (HGPS) and processing deficient progeroid laminopathy (PDPL), two ultra-rare paediatric diseases…
17 Jan 24
The approval was based on results from the Phase IB/III IMscin001 study which showed the SC formulation showed…
09 Jan 24
EU health regulator has approved the combination for adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom…