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FDA approvals 2019

- PMLiVE

Pfizer/Genmab’s Tivdak granted full FDA approval for recurrent or metastatic cervical cancer

It is estimated that more than 13,960 new cases of invasive cervical cancer were diagnosed in the US last year

- PMLiVE

Genmab to expand oncology portfolio through $1.8bn ProfoundBio acquisition

The deal includes a next-generation ADC being evaluated as a treatment for ovarian cancer and other solid tumours

- PMLiVE

Seagen and Genmab’s Tivdak shows promise in phase 3 cervical cancer trial

The drug received FDA accelerated approval in 2021 to treat patients with advanced disease

- PMLiVE

AbbVie and Genmab’s blood cancer therapy granted FDA accelerated approval

Approximately 150,000 new cases of DLBCL are diagnosed globally each year

- PMLiVE

FDA approves Seagen/Genmab’s antibody-drug conjugate Tivdak for women with advanced cervical cancer

The drug has been granted accelerated approval, and the companies have also released positive data on first-line treatment

- PMLiVE

Genmab enters oncology collaboration with Bolt Biotherapeutics

Companies will work together to develop up to three bispecific immune-stimulating antibody conjugates

- PMLiVE

Novartis gains EU approval for relapsing MS drug Kesimpta

The drug reduces the number of confirmed relapses in MS patients

- PMLiVE

Mega-mergers dominate as buoyant markets lift biopharma

BridgeBio records biggest flotation in H1

- PMLiVE

FDA will maintain the pace, vows Woodcock, but warns of skills gap

Top official unconcerned by dip in approval rate

- PMLiVE

J&J takes option on Genmab follow-up to Darzalex

Blockbuster partners look to next chapter - while takeover talk persists

Novartis day

FDA clears Novartis’ new breast cancer drug Piqray

Blockbuster potential for PI3K drug

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