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Astrazeneca
NEWS

AstraZeneca Receives the US FDA Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

Shots: FDA granted accelerated approval to Etcamah + a CDK4/6 inhibitor for HR+/HER2− LA/M breast cancer with an ESR1 mutation emerging during AI + CDK4/6 inhibitor therapy, alongside approval of a ctDNA-based CDx for detecting ESR1 resistance mutations Approval was based on the P-III (SERENA-6) trial assessing Etcamah + CDK4/6 inhibitor vs AI (anastrozole/letrozole) +…
September 7, 2026

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NEWS

Revolution Medicines Reports the US FDA Approval of Rasonque (Daraxonrasib) for Previously Treated Metastatic PDAC

Shots: FDA has approved Revolution’s Rasonque to treat pts with metastatic pancreatic ductal adenocarcinoma (PDAC) who have received ≥1 prior systemic therapy or who are not candidates for multiagent systemic therapy Approval was backed by P-III (RASolute 302) trial assessing Rasonque (300mg, QD, PO) vs CT, in the above-mentioned pts, regardless of RAS mutation, which met…
August 27, 2026

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NEWS

BeOne Medicines Reports the US FDA Approval of Tevimbra + Ziihera to Treat HER2+ GEA

Shots: The US FDA has approved the sBLA for Tevimbra (tislelizumab) + Ziihera (zanidatamab) & CT for the 1L treatment of adults with unresectable locally advanced or metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma (GEA)  Approval was based on the P-III (HERIZON-GEA-01) assessing the efficacy & safety of Ziihera+ CT, with and without Tevimbra, to the…
August 26, 2026

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Rhythm Pharmaceuticals
NEWS

Rhythm Pharmaceuticals’ Imcivree Secures MHLW Approval for Acquired Hypothalamic Obesity

Shots: The MHLW has approved Imcivree (setmelanotide) for pts (≥4yrs.) with acquired hypothalamic obesity (HO); commercial launch is expected by end of 2026, pending final pricing determination Approval was backed by the P-III (TRANSCEND) trial assessing Imcivree in 142 pts with acquired HO, incl. Japanese (n=12) & supplemental pts (n=10), which met its 1EP with…
August 25, 2026

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ArkBio
NEWS

ArkBio’s Ziresovir Secures the US FDA Approval for P-II Trial in RSV Infant Patients

Shots: The US FDA has approved ziresovir (AK0529) for a P-II trial in the severely ill RSV infected infant patients, including those in the pediatric intensive care unit (PICU) The trial will compare ziresovir with PBO to evaluate clinical efficacy, particularly oxygen-treatment duration & sustained recovery time, generating data to support future registrational trials In…
August 14, 2026

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Regeneron New
NEWS

Health Canada Approves Regeneron’s Libtayo for Adjuvant Treatment of High-Risk Cutaneous Squamous Cell Carcinoma

Shots: Health Canada has approved Libtayo (cemiplimab) for the adj. treatment of adults with CSCC who are at high risk for recurrence after surgery & radiation Approval was based on the P-III (C-POST) trial assessing adj. Libtayo (n=209) vs PBO (n=206) to treat high-risk CSCC pts (N=415) Trial showed a 68% reduction in disease recurrence…
August 7, 2026

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Pfizer New
NEWS

Pfizer Receives the US FDA Priority Review for Talzenna + Xtandi to Treat HRR-Gene Mutated mCSPC

Shots: The US FDA has accepted sNDA & granted priority review to Talzenna (talazoparib) + Xtandi (enzalutamide) to treat men with HRR gene-altered mCSPC, with PDUFA action date in Q4’26. Regulatory review is ongoing in the EU sNDA was supported by the P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi…
July 24, 2026

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