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NEWS

Artios’ Alnodesertib Obtains the US FDA’s Fast Track Designation for ATM-negative Metastatic Colorectal Cancer

Shots: The US FDA has granted FTD to alnodesertib + low-dose irinotecan as the 3L treatment of adults with ATM-negative metastatic colorectal cancer (mCRC) Designation was based on the P-I/II (STELLA) trial (ongoing in the US) assessing the regimen in solid tumors with ATM deficiency, which showed responses in 3L mCRC & 7 additional solid…
September 25, 2025

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Astrazeneca & Daiichi Sankyo
NEWS

Daiichi Sankyo and AstraZeneca Receive the US FDA’s Priority Review for Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots: The US FDA has accepted sBLA & granted priority review to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jan 23, 2026) sBLA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta…
September 24, 2025

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NEWS

AstraZeneca and Amgen Report the CHMP’s Positive Opinion of Tezspire (Tezepelumab) for CRSwNP

Shots: The CHMP has recommended Tezspire for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); regulatory review is ongoing in the US, China, Japan & other countries Opinion was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by a post-treatment follow-up duration…
September 24, 2025

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INSIGHTS+

New Drug Designations – August 2025     

Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA    The August 2025 report covers designations granted to 37 drugs and 4 medical devices, spanning 14 small molecules, 5 biologics, 7 cell and gene therapies & 4 medical devices, among others    Significant…
September 23, 2025

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Ionis
NEWS

Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome

Shots: The EC has approved Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome Approval was based on P-III (Balance) trial assessing Tryngolza (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute pancreatitis events over 12mos.; data…
September 23, 2025

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Merck
NEWS

Merck’s Keytruda Qlex Receives the US FDA’s Approval for Subcutaneous Use Across 38 Solid Tumor Indications for Keytruda

Shots: The US FDA has approved Keytruda Qlex (pembrolizumab & berahyaluronidase alfa-pmph) for subcutaneous dosing in adults across 38 approved indications of Keytruda, with US availability expected by late Sep 2025 Approval was based on P-III (3475A-D77) trial assessing Keytruda Qlex (790mg/9600 units, Q6W) + Pt doublet CT vs IV Keytruda (400mg, Q6W) + Pt doublet CT…
September 22, 2025

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Merck new
NEWS

The CHMP Adopts Positive Opinion on Merck’s Enflonsia for RSV Prevention in Infants

Shots: The CHMP has recommended Enflonsia to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season, with potential approval valid in all 30 EEA states Opinion was based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk…
September 22, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)   

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 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:    MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC  Read More: MAIA Biotechnology  Akeso Reports First…
September 19, 2025

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NEWS

KalVista Pharmaceuticals Reports EC and Swissmedic Approval of Ekterly (Sebetralstat) for Hereditary Angioedema (HAE) 

Shots:  The EC and Swissmedic have approved Ekterly to treat acute HAE attacks in pts (age≥12) across EEA states. Launch is expected in Germany in Q4’25 and in Switzerland in H2’26  Ekterly’s approval by the EC and Swissmedic was based on the P-III (KONFIDENT) trial. Published in NEJM (May 2024), results showed significantly faster symptom…
September 19, 2025

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