U.S. FDA approves Yescarta for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

5 March 2021 - Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma; approval marks the third ...

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Genentech’s Actemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis associated interstitial lung disease, a rare, debilitating condition

4 March 2021 - The U.S. FDA previously granted priority review designation to Actemra for the treatment of systemic sclerosis-associated ...

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ICER publishes final evidence report and policy recommendations on roxadustat

5 March 2021 - Independent appraisal committee determines the evidence is not adequate to demonstrate that roxadustat provides a net ...

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PBAC Public Summary Documents - November 2020 meeting

5 March 2021 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the November 2020 PBAC ...

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Ofev (nintedanib) receives positive recommendation from CADTH and INESSS for the treatment of progressive fibrosing interstitial lung diseases

4 March 2021 - Ofev is the first treatment available in Canada for chronic fibrosing interstitial lung diseases with a progressive ...

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FDA approves Accu-Joint hemi implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal joint

2 March 2021 - The Accu-Joint is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in ...

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U.S. FDA expands approval of Pfizer's Lorbrena as first-line treatment for ALK positive metastatic lung cancer

3 March 2021 - Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or ...

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NICE rejects rare blood cancer treatment Poteligeo in final appraisal

4 March 2021 - The UK’s NICE has not recommended Kyowa Kirin’s Poteligeo for the treatment of adults living with ...

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FDA grants de novo to ML-based, real-time indicator of patient deterioration

2 March 2021 - Fifth Eye's non-invasive tool is the first to provide continuous monitoring of haemodynamic status using a single ...

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NICE backs NHS use of Lilly’s Olumiant in eczema

3 March 2021 - Eli Lilly’s Olumiant has received a UK NICE recommendation for the treatment of moderate-to-severe atopic dermatitis ...

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Health Canada approves Brukinsa (zanubrutinib) for the treatment of Waldenström’s macroglobulinaemia

2 March 2021 - Approval is based on the Phase 3 ASPEN trial of Brukinsa compared to ibrutinib. ...

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Relivion wearable brain neuromodulation technology cleared by FDA for the treatment of migraine

2 March 2021 - Relivion is the only non-invasive multi-channel neuromodulation technology for the treatment of acute migraine. ...

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ICER publishes Final Evidence Report and policy recommendations on new therapies for high cholesterol

2 March 2021 - For bempedoic acid, independent appraisal committee votes that the evidence is not adequate to demonstrate a net ...

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Merck provides update on Keytruda (pembrolizumab) indication in metastatic small cell lung cancer in the US

1 March 2021 - Merck today announced the company is voluntarily withdrawing the U.S. indication for Keytruda (pembrolizumab) for the treatment ...

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Apollo Endosurgery Receives FDA breakthrough device designation for the Orbera intragastric balloon for treatment of patients with NASH

1 March 2021 - Apollo Endosurgery announced today that it has received a breakthrough device designation from the U.S. FDA for ...

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