D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002

Shots: FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…

ByDipanshu DixitJanuary 19, 2026

NEWS

Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin)

Shots: The US FDA has accepted the BLA for HLX04, a biosimilar version of Avastin (bevacizumab) BLA was supported by analytical similarity studies, a P-I PK comparability trial in healthy subjects, and a multicenter P-III trial in pts with metastatic colorectal cancer, evaluating HLX04 vs the reference product for safety, PK, and immunogenicity Henlius is advancing a P-II/III trial of HLX04 + serplulimab for 1L…

ByDipanshu DixitJanuary 13, 2026

VIEWPOINTS

Enhancing DMD Care: Phil Lambert from Satellos in a Riveting Conversation with PharmaShots

Shots: Conventional therapeutic models for Duchenne Muscular Dystrophy (DMD) primarily focus on the role of dystrophin in maintaining muscle cell integrity. However, Satellos’ SAT-3247 takes a novel approach, targeting the lack of dystrophin in muscle stem cells to restore muscle fiber regeneration and repair Today at PharmaShots, we are joined by Phil Lambert, Chief Scientific…

BySaurabh ChaubeyNovember 20, 2024

THOUGHTSPOT

Clinical Trial to Study Effectiveness of Cancer Treatment Administered 2024

There are tons of clinical trials taking place at this moment. It’s a nasty disease and it’s important to figure out different ways to diagnose it, treat it, and, if possible, prevent it. 2024 brings on innovations in this field. It can probably shed light on how cancer can become more treatable and not such…

ByJack TurnerJune 20, 2024

THOUGHTSPOT

The New Normal and Covid-19 Vaccine Development

Since the virus outbreak in China, all eyes are on the most awaited Covid-19 vaccine offering a glimmer of hope. Abide by social distancing, wearing a mask, and frequent hand washing - until we have a vaccine. This new mantra amidst all misery has created hope in the hearts of many. We have to accept…

BySenior EditorAugust 5, 2020

D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002

Shanghai Henlius Reports the US FDA’s BLA Acceptance for HLX04 (Biosimilar, Avastin)

Enhancing DMD Care: Phil Lambert from Satellos in a Riveting Conversation with PharmaShots

Clinical Trial to Study Effectiveness of Cancer Treatment Administered 2024

The New Normal and Covid-19 Vaccine Development

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