Sydnexis’ SYD-101 Receives the EC’s Approval to Reduce Pediatric Myopia Progression

Shots: The EC has approved SYD-101 to slow pediatric myopia progression; NDA is under the US FDA’s review (PDUFA: Oct 23, 2025) Approval was based on P-III (STAR) trial evaluating SYD-101 to reduce pediatric myopia progression & risk of associated co-morbidities in pts (3-14yrs. at trial initiation), which met its 3yr. 1EP, with third-year data…

ByRidhi RastogiJune 6, 2025

NEWS

AstraZeneca’s Calquence Regimen Receives the EC’s Approval for 1L Chronic Lymphocytic Leukaemia (CLL)

Shots: The EC has approved Calquence (acalabrutinib) + venetoclax ± Gazyva for the treatment of adults with 1L CLL; regulatory review is ongoing in other regions Approval was based on the P-III (AMPLIFY) trial assessing Calquence regimen with or without Gazyva vs chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) in treatment-naïve CLL pts without del(17p) or TP53 mutation Trial showed…

ByRidhi RastogiJune 6, 2025

NEWS

HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

Shots: China’s NMPA has accepted NDA of fruquintinib + sintilimab for the treatment of pts with locally advanced or metastatic renal cell carcinoma who have progressed on one tyrosine kinase inhibitor therapy NDA is backed by the P-II/III (FRUSICA-2) trial assessing fruquintinib + sintilimab vs axitinib/everolimus monotx. for 2L treatment of renal cell carcinoma pts…

ByRidhi RastogiJune 5, 2025

NEWS

The EC Approves Roche’s Evrysdi Tablet for Spinal Muscular Atrophy

Shots: The EC has approved label extension of Evrysdi (5mg oral tablet) for pts with spinal muscular atrophy (SMA) Approval was based on P-I study assessing Evrysdi 5mg tablet vs oral solution, showing bioequivalence with comparable efficacy & safety; data was presented at SMA Europe 2024 Evrysdi, an SMN2 splicing modifier, treats SMA caused by…

ByRidhi RastogiJune 5, 2025

NEWS

Takeda’s Adcetris Regimen Receives the EC’s Approval to Treat Newly Diagnosed Hodgkin Lymphoma

Shots: The EC has approved Adcetris (brentuximab vedotin) + ECADD (etoposide, cyclophosphamide, doxorubicin, dacarbazine & dexamethasone) to treat adults with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma following CHMP’s positive opinion in Apr 2025 Approval was based on P-III (HD21) trial assessing Adcetris + ECADD vs escalated doses of BEACOPP in above pts,…

ByRidhi RastogiJune 4, 2025

NEWS

Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: The US FDA has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts; approval process in the EU is ongoing Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT (n=446) vs PBO + ADT (n=223) in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP),…

ByRidhi RastogiJune 4, 2025

NEWS

Moderna’s mNEXSPIKE Receives the US FDA’s Approval to Protect Against COVID-19

Shots: The US FDA has approved mNEXSPIKE (mRNA-1283) for active immunization against COVID-19 in individuals (≥12yrs.) with ≥1 underlying risk factor as defined by Centers for Disease Control and Prevention; regulatory review is ongoing in other regions Approval was based on P-III (NextCOVE) trial assessing mNEXSPIKE (10 or 50μg) vs Spikevax (mRNA-1273) in ~11,400 subjects…

ByRidhi RastogiJune 3, 2025

NEWS

GSK Reports the US FDA’s NDA Acceptance of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: The US FDA has accepted NDA of linerixibat for the treatment of cholestatic pruritus in PBC pts (PDUFA: Mar 24, 2026) NDA is supported by P-III (GLISTEN) trial assessing linerixibat (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial Trial…

ByRidhi RastogiJune 2, 2025

NEWS

Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

Shots: The US FDA has accepted NDA & granted priority review seeking full approval of ziftomenib to treat adults with r/r acute myeloid leukemia (AML) with NPM1 mutation (PDUFA: Nov 30, 2025) NDA is supported by P-II (KOMET-001) trial assessing ziftomenib in r/r NPM1-mutant AML pts, which met its 1EP of CR & CR with…

ByRidhi RastogiJune 2, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (May 26, 2025 – May 30, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A & Biosimilar. Check out our full report below:  Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC) Read More: Gilead Genentech Reports P-III (STARGLO) Trial Data on Columvi for R/R Diffuse Large B-Cell Lymphoma…

ByRidhi RastogiMay 30, 2025

Sydnexis’ SYD-101 Receives the EC’s Approval to Reduce Pediatric Myopia Progression

AstraZeneca’s Calquence Regimen Receives the EC’s Approval for 1L Chronic Lymphocytic Leukaemia (CLL)

HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma

The EC Approves Roche’s Evrysdi Tablet for Spinal Muscular Atrophy

Takeda’s Adcetris Regimen Receives the EC’s Approval to Treat Newly Diagnosed Hodgkin Lymphoma

Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Moderna’s mNEXSPIKE Receives the US FDA’s Approval to Protect Against COVID-19

GSK Reports the US FDA’s NDA Acceptance of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Kura Oncology and Kyowa Kirin Report the US FDA’s NDA Acceptance and Priority Review of Ziftomenib for Acute Myeloid Leukemia

PharmaShots Weekly Snapshots (May 26, 2025 – May 30, 2025)

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