Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots:The US FDA has approved Libtayo (cemiplimab-rwlc) under priority review as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiation; application under EMA’s review, with decision expected in H1’26Approval was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks.…

ByRidhi RastogiOctober 9, 2025

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Jazz Pharmaceuticals and Genentech Report the US FDA’s Approval of Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) for ES-SCLC

Shots:The US FDA has granted full approval to Zepzelca + Tecentriq as a 1L therapy for ES-SCLC pts whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposideApproval was based on P-III (IMforte) trial results, showing Zepzelca + Tecentriq reduced risk of progression or death by 46% & death risk by…

ByRidhi RastogiOctober 3, 2025

NEWS

Genmab to Acquire Merus for ~$8B

Shots:Genmab has entered into a transaction agreement to acquire Merus, incl. its lead asset petosemtamab, expanding its late-stage pipeline & accelerating Genmab’s shift to a wholly owned modelAs per the deal, Genmab will acquire Merus for $97 per share in an all-cash transaction, representing the deal value of ~$8B, with closing expected in the…

ByRidhi RastogiSeptember 29, 2025

NEWS

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 inhibitorsTT125-802 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

NEWS

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 therapyTrial showed…

ByRidhi RastogiAugust 11, 2025

NEWS

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 inhibitorDesignation 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

NEWS

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

Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Jazz Pharmaceuticals and Genentech Report the US FDA’s Approval of Zepzelca (Lurbinectedin) + Tecentriq (Atezolizumab) for ES-SCLC

Genmab to Acquire Merus for ~$8B

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

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