TOLREMO Therapeutics’ TT125-802 Secures 2 US FDA’s Fast-Track Designation for NSCLC with EGFR & KRAS-G12C Mutation

Shots: The US FDA has granted 2 FTDs to TT125-802 for NSCLC: one for EGFR exon 19 deletion or exon 21 L858R mutation pts progressing after EGFR inhibitors, & another for KRAS G12C-mutated pts progressing after KRAS G12C inhibitors TT125-802 is being assessed in P-I trial to evaluate its safety, tolerability, PK, & efficacy in…

ByRidhi RastogiAugust 29, 2025

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Jazz Pharmaceuticals at ASCO 2025: Robert lannone in an Illuminating Conversation with PharmaShots

Shots: Jazz Pharmaceuticals and partners presented seven abstracts from their oncology development program at ASCO 2025 Robert Iannone, EVP, Global Head of Research and Development, and Chief Medical Officer at Jazz Pharmaceuticals, in an engaging discussion with PharmaShots, shared insights from the P-III IMforte trial assessing Zepzelca plus atezolizumab in first-line maintenance treatment for Extensive…

BySaurabh ChaubeyAugust 25, 2025

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Jazz Pharmaceuticals at ASCO 2025: Robert Iannone in a Stimulating Conversation with PharmaShots

Shots: Jazz Pharmaceuticals and partners presented seven abstracts from their oncology development program at ASCO 2025 Robert Iannone, CMO, EVP, Global Head of Research and Development, and Chief Medical Officer at Jazz Pharmaceuticals, in an engaging discussion with PharmaShots, shared four-year follow-up data from an ongoing P-II trial of Ziihera in combination with CT for…

BySaurabh ChaubeyAugust 11, 2025

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Arvinas Reports the US FDA’s NDA Acceptance of Vepdegestrant for ESR1-Mutated Breast Cancer

Shots: The US FDA has accepted NDA of vepdegestrant to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy (PDUFA: Jun 5, 2026) NDA was backed by P-III (VERITAC-2) trial assessing vepdegestrant alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapy Trial showed…

ByRidhi RastogiAugust 11, 2025

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The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Shots: The US FDA has granted FTD to Birelentinib (DZD8586) for the treatment of adults with r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received ≥2L of therapy, incl. a BTK & a BCL-2 inhibitor Designation was based on pooled P-I/II data showing 84.2% ORR & DoR rate of 83.3% at 9mos.…

ByRidhi RastogiAugust 8, 2025

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Zai Lab at ASCO 2025: Rafael G. Amado in an Illuminating Dialogue Exchange with PharmaShots

Shots: Recently, Zai Lab presented data from a Phase Ia/Ib study evaluating ZL‑1310, a DLL3 ADC, in patients with extensive‑stage small cell lung cancer, both as a monotherapy and in combination with atezolizumab ZL‑1310 leverages TMALIN technology, enabling clinicians to deliver more targeted doses of chemotherapy to cancer cells, distinguishing the compound from current standard‑of‑care…

BySaurabh ChaubeyJuly 23, 2025

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Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has accepted sNDA of Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, ineligible for intensive induction CT (PDUFA: Feb 25, 2026) sNDA was backed by P-IIb (ASCERTAIN-V) trial in 101 adults with newly diagnosed AML ineligible for intensive induction CT, where pts…

ByRidhi RastogiJuly 10, 2025

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Johnson & Johnson Seeks the EC’s Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

The EMA has received an application for label expansion of Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone to treat adults with mHSPC & HRR gene alterations Submission was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered…

ByRidhi RastogiJuly 4, 2025

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Bio-Thera Solutions Reports First Patient Dosing in P-III Study Evaluating BAT8006 for Pt Resistant Ovarian Cancer

Shots: Bio‑Thera reported the dosing of the first patient in a P‑III study assessing the efficacy of BAT8006 vs. the investigator’s choice of single-agent CT in individuals with Pt resistant high‑grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer Early clinical Data (N=133; irrespective of FRα expression or treatment history) presented at ASCO’25, from…

ByPrince GiriJune 26, 2025

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Verastem Oncology Reports First Patient Dosing with VS-7375 in P-I/IIa Study for KRAS G12D Advanced Solid Tumors

Shots: Verastem reported the dosing of the first patient (US) for P-I/IIa study (VS-7375-101) assessing the safety, tolerability, and efficacy of VS-7375 The dose-escalation phase of the study starts at 400mg, based on results from a P-I/II study conducted by GenFleet in China, and presented initial safety and efficacy data at ASCO’25 Upon reaching the…

ByPrince GiriJune 25, 2025

TOLREMO Therapeutics’ TT125-802 Secures 2 US FDA’s Fast-Track Designation for NSCLC with EGFR & KRAS-G12C Mutation

Jazz Pharmaceuticals at ASCO 2025: Robert lannone in an Illuminating Conversation with PharmaShots

Jazz Pharmaceuticals at ASCO 2025: Robert Iannone in a Stimulating Conversation with PharmaShots

Arvinas Reports the US FDA’s NDA Acceptance of Vepdegestrant for ESR1-Mutated Breast Cancer

The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Zai Lab at ASCO 2025: Rafael G. Amado in an Illuminating Dialogue Exchange with PharmaShots

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Johnson & Johnson Seeks the EC’s Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Bio-Thera Solutions Reports First Patient Dosing in P-III Study Evaluating BAT8006 for Pt Resistant Ovarian Cancer

Verastem Oncology Reports First Patient Dosing with VS-7375 in P-I/IIa Study for KRAS G12D Advanced Solid Tumors

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