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…

ByRidhi Rastogi3 days ago

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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…

ByRidhi Rastogi4 days ago

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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…

ByRidhi RastogiAugust 25, 2026

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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…

ByRidhi RastogiAugust 14, 2026

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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…

ByRidhi RastogiAugust 7, 2026

NEWS

US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

Shots: FDA has accepted the sBLA of Enflonsia to prevent RSV lower respiratory tract disease (LRTD) in children (<2yrs.) at increased risk for severe RSV disease through their second RSV season (PDUFA: Mar 22, 2027); application is also under EMA review Submissions were supported by P-III (SMART/MK-1654-007) trial assessing Enflonsia in infants & children over…

ByRidhi RastogiAugust 7, 2026

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

Shots: The EC has approved Etcamah + a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for adults with ER+, HER2- locally advanced or metastatic breast cancer with an ESR1 mutation & no progression on 1L endocrine therapy + CDK4/6 inhibitor; regulatory review is ongoing in the US Approval was based on the P-III (SERENA-6) trial assessing…

ByRidhi RastogiJuly 24, 2026

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…

ByRidhi RastogiJuly 24, 2026

NEWS

Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Shots: The US FDA has accepted the NDA for Revolution Medicines’ daraxonrasib to treat pts with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), plus daraxonrasib was selected for the FDA CNPV pilot program NDA was backed by P-III (RASolute 302) trial assessing daraxonrasib (300mg, QD, PO) vs CT, in above-mentioned pts, regardless of RAS mutation, which…

ByRidhi RastogiJuly 23, 2026

NEWS

Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Shots: The US FDA has granted Priority Review to the sBLA of Gazyva/Gazyvaro (obinutuzumab) in pMN, based on the P-III (MAJESTY) study assessing Gazyva vs tacrolimus in adults (n=142), with a decision expected by Nov 2026 Trial met its 1EP, with 36.9% adults achieving CR at 2yrs. vs 5.7%, plus showed superiority across key 2EPs…

ByRidhi RastogiJuly 15, 2026

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

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

Rhythm Pharmaceuticals’ Imcivree Secures MHLW Approval for Acquired Hypothalamic Obesity

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

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

US FDA Accepts sBLA for Merck’s Enflonsia to Expand RSV LRTD Prevention Indication

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

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

Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

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