The US FDA Grants Breakthrough Therapy Designation to Eli Lilly’s Olomorasib for KRAS G12C-Mutant NSCLC

Shots: The US FDA has granted BTD to olomorasib + Keytruda for the 1L treatment of pts with unresectable advanced or metastatic NSCLC harboring KRAS G12C mutation & PD-L1 expression ≥ 50% Designation was based on P-I/II (LOXO-RAS-20001) trial of olomorasib monotx. & dose optimization portion from P-III (SUNRAY-01) trial of olomorasib + Keytruda ±…

ByRidhi RastogiSeptember 5, 2025

NEWS

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the Health Canada’s Approval to Treat Platinum-Resistant Ovarian Cancer

Shots: Health Canada has approved Elahere under priority review to treat FRα+, Pt-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatments Approval was based on P-III (MIRASOL) trial assessing Elahere vs investigator's choice of CT in pts (n=453) to treat PROC expressing high levels of FRα, as determined using the Ventana…

ByRidhi RastogiSeptember 4, 2025

NEWS

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

Shots: The US FDA has accepted NDA of ensitrelvir fumaric acid for the prevention of COVID-19 following exposure to an infected individual (PDUFA: Jun 16, 2026); regulatory review is ongoing in Taiwan, Japan (for both PEP & paediatric pts), & the EU NDA was supported by global P-III (SCORPIO-PEP) trial assessing ensitrelvir vs PBO as post-exposure…

ByRidhi RastogiSeptember 3, 2025

NEWS

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots: China’s NMPA has granted conditional approval to Hernexeos (zongertinib) for treating pts with inoperable, locally advanced or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy Approval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos alone, which showed improved ORR of 71% (N=75: 7% CR), mDoR of 14.1mos. & mPFS…

ByRidhi RastogiSeptember 1, 2025

NEWS

Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

Shots: FDA has approved Wayrilz for adults with persistent or chronic ITP who did not respond adequately to prior therapy following approval in UAE in Jun 2025; Application under the EMA & NMPA's review Approval was based on P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO in adults (n=202) with ITP over…

ByRidhi RastogiSeptember 1, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 25, 2025 – Aug 29, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, M&A and Biosimilars. Check out our full report below:  argenx Reports Topline P-III (ADAPT SERON) Trial Data of Vyvgart for AChR-Ab Seronegative Generalized Myasthenia Gravis Read More: argenx PDS Biotech Reports Final P-II (VERSATILE-002) Survival Data for PDS0101 + Keytruda…

ByRidhi RastogiAugust 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 inhibitors TT125-802 is being assessed in P-I trial to evaluate its safety, tolerability, PK, & efficacy in…

ByRidhi RastogiAugust 29, 2025

NEWS

Foresee Pharmaceuticals’ Camcevi ETM Receives the US FDA Approval for Advanced Prostate Cancer

Shots: The US FDA has approved Camcevi ETM (leuprolide mesylate, 21mg, Q3M LAI) for the treatment of advanced prostate cancer; Application is under the EMA’s review Approval was based on P-III trial assessing Camcevi ETM in 144 advanced prostate cancer pts, which showed superior efficacy, with 97.9% pts achieving the 1EP Camcevi (Q6M LAI) is…

ByRidhi RastogiAugust 29, 2025

NEWS

ExCellThera Reports the EC’s Conditional Approval of Zemcelpro for Haematological Malignancies

Shots: The EC has granted conditional approval to Zemcelpro in all 30 EEA states for adults with haematological malignancies needing ASCT after myeloablative conditioning, when no other suitable donor cells are available; regulatory filing is underway in the US, UK, Canada & Switzerland Zemcelpro availability will vary by country based on national reimbursement processes; meanwhile,…

ByRidhi RastogiAugust 29, 2025

NEWS

AbbVie’s Rinvoq (Upadacitinib) Receives the Health Canada Approval for Giant Cell Arteritis

Shots: Health Canada has approved Rinvoq (15mg; QD) as a monotx. & in combination with corticosteroid to treat adults with giant cell arteritis (GCA) Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in 1st study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO +…

ByRidhi RastogiAugust 28, 2025

The US FDA Grants Breakthrough Therapy Designation to Eli Lilly’s Olomorasib for KRAS G12C-Mutant NSCLC

AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the Health Canada’s Approval to Treat Platinum-Resistant Ovarian Cancer

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

PharmaShots Weekly Snapshots (Aug 25, 2025 – Aug 29, 2025)

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

Foresee Pharmaceuticals’ Camcevi ETM Receives the US FDA Approval for Advanced Prostate Cancer

ExCellThera Reports the EC’s Conditional Approval of Zemcelpro for Haematological Malignancies

AbbVie’s Rinvoq (Upadacitinib) Receives the Health Canada Approval for Giant Cell Arteritis

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