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Merck’s investigational ADC with R-CHP demonstrates 100% response rate for B-cell lymphoma
Clinical Trials | December 09, 2024

Merck’s investigational ADC with R-CHP demonstrates 100% response rate for B-cell lymphoma

Based on data, 1.75 mg/kg dose established as recommended dose for Phase 3 trial of this investigational antibody-drug conjugate


Roche’s Polivy combination therapy sets new standard of care for untreated aggressive lymphoma
Clinical Trials | December 09, 2024

Roche’s Polivy combination therapy sets new standard of care for untreated aggressive lymphoma

Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems


FDA accepts supplemental Biologics License Application for Roche’s Columvi combination
Drug Approval | December 06, 2024

FDA accepts supplemental Biologics License Application for Roche’s Columvi combination

For people with relapsed or refractory diffuse large B-cell lymphoma


FDA approves BridgeBio’s Attruby for ATTR-CM treatment
Biotech | November 26, 2024

FDA approves BridgeBio’s Attruby for ATTR-CM treatment

Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR


Merck announces pivotal phase 3 ZENITH trial evaluating WINREVAIR
News | November 26, 2024

Merck announces pivotal phase 3 ZENITH trial evaluating WINREVAIR

WINREVAIR met primary endpoint of time to first morbidity or mortality event for the treatment of patients with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality


USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma
Drug Approval | November 25, 2024

USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma

If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse


European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors
Drug Approval | November 21, 2024

European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors

HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors


Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer
Drug Approval | November 19, 2024

Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer

Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years


Blenrep shows overall survival benefit in DREAMM-7 phase III trial for relapsed/refractory multiple myeloma
Clinical Trials | November 19, 2024

Blenrep shows overall survival benefit in DREAMM-7 phase III trial for relapsed/refractory multiple myeloma

Statistically significant and clinically meaningful reduction in the risk of death seen with Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone (BorDex) versus daratumumab plus BorDex