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1396 News Found

Roche provides update on astegolimab in chronic obstructive pulmonary disease
Clinical Trials | July 21, 2025

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


Roche updates on sBLA for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
Clinical Trials | July 21, 2025

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
Drug Approval | July 21, 2025

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


ImCheck’s ICT01 receives FDA ODD for treatment of acute myeloid leukemia
Clinical Trials | July 21, 2025

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


Suven Life Sciences announces first patient randomized in Phase-2b clinical trial of Ropanicant
Clinical Trials | July 17, 2025

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%
Drug Approval | July 15, 2025

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,


Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy
News | July 15, 2025

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025


AstraZeneca's Baxdrostat met the primary and all secondary endpoints in BaxHTN Phase III trial
Clinical Trials | July 14, 2025

AstraZeneca's Baxdrostat met the primary and all secondary endpoints in BaxHTN Phase III trial

Baxdrostat demonstrated a statistically significant and clinically meaningful reduction of systolic blood pressure compared with placebo


Merck to initiate Phase 3 trials for investigational once-monthly HIV prevention pill
News | July 14, 2025

Merck to initiate Phase 3 trials for investigational once-monthly HIV prevention pill

In collaboration with the Gates Foundation, Merck advances MK-8527 pre-exposure prophylaxis (PrEP) clinical trials globally


Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause
Drug Approval | July 11, 2025

Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause

The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials