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3401 News Found

Lonza reports 19% growth in sales in H1
News | July 23, 2025

Lonza reports 19% growth in sales in H1

Upgrades 2025 full-year CDMO sales and margin outlook


AstraZeneca plans to invest $50 billion in US by 2030
News | July 22, 2025

AstraZeneca plans to invest $50 billion in US by 2030

Investment will support AstraZeneca’s ambition to reach $80 billion revenue by 2030, with 50% generated in the US


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


SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally
Drug Approval | July 17, 2025

SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally

The receipt of EIR reaffirms the company's commitment to maintaining global quality standards


Thermo Fisher Scientific to acquire Sanofi’s steriles manufacturing site in Ridgefield, New Jersey
News | July 17, 2025

Thermo Fisher Scientific to acquire Sanofi’s steriles manufacturing site in Ridgefield, New Jersey

Enables additional US manufacturing capacity to serve increased demand for pharma/biotech customers


Zydus receives final approval from USFDA for Celecoxib Capsules
Drug Approval | July 15, 2025

Zydus receives final approval from USFDA for Celecoxib Capsules

Celecoxib is a nonsteroidal anti-inflammatory drug


Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL
Drug Approval | July 15, 2025

Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL

Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments