Roche updates on sBLA for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths

Roche provides update on astegolimab in chronic obstructive pulmonary disease

The phase III ARNASA study did not meet the primary endpoint of a statistically significant reduction in the AER at 52 weeks

Sun Pharma’s phase 3 Cclinical studies for Tildrakizumab 100 mg meet primary endpoint

The INSPIRE-1 and INSPIRE-2 trials are Phase 3 studies assessing the efficacy and safety of tildrakizumab 100 mg (ILUMYA) in adults with active psoriatic arthritis (PsA)

AstraZeneca’s Tagrisso plus chemotherapy improves overall survival in EGFR-mutated advanced lung cancer

Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination

ImCheck’s ICT01 receives FDA ODD for treatment of acute myeloid leukemia

Clinical data showing unprecedented remission rates in newly diagnosed AML patients support advancing ICT01 into pivotal trials

Lupin achieves GMP certification from TGA Australia for Dabhasa API facility

Kenvue collaborates with API to launch India’s first cough clinics

Aims to support healthcare practitioners with evidence-based cough categorization tools that enable choosing the right molecules for effective & targeted relief from cough

Suven Life Sciences announces first patient randomized in Phase-2b clinical trial of Ropanicant

There is a significant unmet medical need for antidepressants that are effective, rapid onset of action and to be well tolerated

FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%

Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,