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

NEWS

BeOne Medicine’s Perioperative Tevimbra (Tislelizumab) Receives the EC’s Approval for Resectable NSCLC

Shots: The EC has approved neoadj. Tevimbra + Pt-based CT followed by adj. Tevimbra monotx. for adults with resectable NSCLC at high risk of recurrence Approval was based on P-III (RATIONALE-315) trial assessing perioperative Tevimbra with CT before surgery vs PBO + CT in NSCLC pts (n=453), which met its dual 1EPs of EFS &…

ByRidhi RastogiAugust 27, 2025

NEWS

Bayer Reports the US FDA’s NDA Acceptance of Gadoquatrane for Contrast-Enhanced MRI

Shots: The US FDA has accepted NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. neonates; MAA was submitted to MHLW & EMA with further filings planned in other regions NDA was supported by the QUANTI clinical program, which incl.…

ByRidhi RastogiAugust 27, 2025

NEWS

Gilead Reports the EC’s Approval of Yeytuo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: Approval was based on P-III (PURPOSE 1 & PURPOSE 2) trials of Yeytuo vs Truvada, where PURPOSE 1 showed 0 infections & 100% risk reduction in 2134 women, while PURPOSE 2 depicted 99.9% non-infection rate in 2179 pts (2 acquired HIV), showing superiority to bHIV in both trials; published in The NEJM Approval is…

ByRidhi RastogiAugust 27, 2025

INSIGHTS+

New Drug Designations: July 2025

Shots:    PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA. The July 2025 edition covers designations awarded to 47 drugs and 3 medical devices, comprising 23 small molecules, 9 biologics, 8 cell and gene therapies, and…

ByRidhi RastogiAugust 26, 2025

NEWS

Daiichi Sankyo’s Datroway (Datopotamab Deruxtecan) Receives the NMPA’s Approval for Unresectable or Recurrent HR+/HER2- Breast Cancer

Shots: China’s NMPA has approved Datroway for treating adults with HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) inoperable or recurrent breast cancer after previous CT Approval was based on P-III (TROPION-Breast01) study assessing Datroway (6mg/kg, IV, Q21D) vs single-agent CT in adults (n=732) with HR+/HER2- metastatic breast cancer Study showed improved PFS by 37%…

ByRidhi RastogiAugust 25, 2025

NEWS

Daiichi Sankyo Reports the MHLW’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: Japan’s MHLW has approved Enhertu monotx. for inoperable HR+, HER2-low/ultralow MBC whose disease progressed on & are ineligible for endocrine therapy Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT in HER2-low (n=713) & ultralow (n=152) pts Trial showed 38% PFS in CT-naïve HER2-low pts & mPFS of 13.2…

ByRidhi RastogiAugust 25, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 18, 2025 – Aug 22, 2025) 

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, and Biosimilars. Check out our full report below:   HUTCHMED Completes Patient Enrolment in P-III (SANOVO) Trial of Orpathys (savolitinib) and Tagrisso (osimertinib) for EGFRm NSCLC Read More: HUTCHMED Akeso Reports First Patient Dosing in P-III (COMPASSION-33) Trial of Cadonilimab for…

ByRidhi RastogiAugust 22, 2025

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

BeOne Medicine’s Perioperative Tevimbra (Tislelizumab) Receives the EC’s Approval for Resectable NSCLC

Bayer Reports the US FDA’s NDA Acceptance of Gadoquatrane for Contrast-Enhanced MRI

Gilead Reports the EC’s Approval of Yeytuo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

New Drug Designations: July 2025

Daiichi Sankyo’s Datroway (Datopotamab Deruxtecan) Receives the NMPA’s Approval for Unresectable or Recurrent HR+/HER2- Breast Cancer

Daiichi Sankyo Reports the MHLW’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

PharmaShots Weekly Snapshots (Aug 18, 2025 – Aug 22, 2025)

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