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Approvals

Set Alert for Approvals

Japan Tirabrutinib Approval Breaks New BTK Ground In Lymphoma

Japan approval for BTK inhibitor marks new indication but in a small niche market, while another clearance may help extend Latuda's commercial life.

Japan Approvals

Novartis Close To EU Approval For Zolgensma At Last

Novartis’s AveXis unit has received a CHMP nod for the spinal muscular atrophy gene therapy at its latest meeting, sending it on the final steps to market in the EU.

Approvals Companies

BMS Gets US Approval Of Ozanimod For Relapsing MS, But Launch Delayed

Zeposia, one of three Celgene candidates central to last year’s merger with BMS, obtains US FDA approval in relapsing MS. BMS, however, will delay the launch due to the COVID-19 pandemic.

Approvals Business Strategies

Japan Enhertu Nod Another Boost For Daiichi's Oncology Hopes

Novel antibody-drug conjugate receives approval in Japan for second-line breast cancer, providing another push to Japanese firm’s strategic plan to build up its oncology operations.

Japan Approvals

Pipeline Watch: Phase III Readouts For Gefapixant, 20-Valent Pneumococcal Vaccine

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Shifting EU Treatment Paradigms In CLL

The CLL market segment in the EU will now include a first-line combination therapy of AbbVie’s venetoclax and Roche’s obinutuzumab, which has recently been approved by the European Commission.

Cancer Approvals

Pipeline Watch: Approvals In Cushing's Syndrome, Hepatocellular Cancer

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Pipeline Watch: Approvals For Sarclisa, Durysta

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Zydus Cadila First Off The Block In NASH After India Approval

Cadila Healthcare has received the first approval globally, in India, for a NASH therapy, after the national regulator cleared its candidate saroglitazar. The company also expects to begin Phase III trials in the US in the second quarter of fiscal 2021.

India Approvals
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