Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has accepted sNDA of Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, ineligible for intensive induction CT (PDUFA: Feb 25, 2026) sNDA was backed by P-IIb (ASCERTAIN-V) trial in 101 adults with newly diagnosed AML ineligible for intensive induction CT, where pts…

ByRidhi RastogiJuly 10, 2025

NEWS

Novo Nordisk Reports the EMA’s Application Submission for Higher Wegovy Dose for Weight Management

Shots: The EMA has received an application for a higher dose of Wegovy (semaglutide 7.2mg, SC) to treat obesity Application was backed by the 72wk. STEP UP trial assessing Wegovy (7.2mg) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 adults without diabetes (BMI ≥30kg/m²), & the 72wk. STEP UP T2D trial assessing Wegovy…

ByRidhi RastogiJuly 9, 2025

NEWS

J&J Reports US FDA’s sNDA Submission of Caplyta for Schizophrenia Relapse Prevention

Shots: The US FDA has received sNDA of Caplyta (lumateperone) for the prevention of relapse in schizophrenia; sNDA of Caplyta as an adjunctive therapy for MDD is under FDA’s review sNDA was supported by withdrawal P-III (Study 304) trial assessing Caplyta (42mg, QD) for 18wk. open-label phase followed by a double-blind phase, where pts received…

ByRidhi RastogiJuly 9, 2025

NEWS

ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

Shots: The UK’s MHRA has approved Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS. MAA is under the EMA’s review & covers all 30 EEA states Approval was based on safety & efficacy data, incl. CR & DoR, from a single-arm trial in 77 pts treated with Anktiva + BCG, with some…

ByRidhi RastogiJuly 8, 2025

NEWS

Denali Therapeutics Reports the US FDA’s BLA Acceptance and Priority Review of Tividenofusp Alfa for Hunter Syndrome

Shots: The US FDA has accepted BLA & granted priority review to tividenofusp alfa for the treatment of Hunter syndrome (MPS II), with PDUFA target action date of Jan 5, 2026 BLA was supported by a P-I/II trial of tividenofusp alfa in 47 MPS II pts, as Denali prepares for its US commercial launch. It…

ByRidhi RastogiJuly 8, 2025

NEWS

KalVista Reports the US FDA’s Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Shots: The US FDA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.), with US availability expected immediately Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries & KONFIDENT-S OLE study KONFIDENT data was published in The NEJM, which showed…

ByRidhi RastogiJuly 7, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jun 30, 2025 – Jul 04, 2025)   

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, and Biosimilar. Check out our full report below:  Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD) Read More: Neurocrine UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients Read More: UCB …

ByRidhi RastogiJuly 4, 2025

NEWS

AstraZeneca Reports the EC’s Approval for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The EC has approved Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regions Approval was based on the P-III (NIAGARA) trial (n=1063) in MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery …

ByRidhi RastogiJuly 4, 2025

NEWS

Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC

Shots: The US FDA has granted accelerated approval to Zegfrovy for locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in pts whose disease has progressed on or after Pt-based CT Approval was based on the multinational WU-KONG1 part B trial assessing Zegfrovy in above mentioned pts, which showed significant improvement…

ByRidhi RastogiJuly 3, 2025

NEWS

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

Shots: The US FDA has granted accelerated approval to Lynozyfic for the treatment of r/r MM pts, who have received ≥4L therapy, incl. a proteasome inhibitor, an immunomodulatory agent & an anti CD38 mAb based on P-I/II (LINKER-MM1) trial in >300 pts; a SC P-I trial portion & IV P-II dose expansion portion is ongoing In…

ByRidhi RastogiJuly 3, 2025

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Novo Nordisk Reports the EMA’s Application Submission for Higher Wegovy Dose for Weight Management

J&J Reports US FDA’s sNDA Submission of Caplyta for Schizophrenia Relapse Prevention

ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

Denali Therapeutics Reports the US FDA’s BLA Acceptance and Priority Review of Tividenofusp Alfa for Hunter Syndrome

KalVista Reports the US FDA’s Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

PharmaShots Weekly Snapshots (Jun 30, 2025 – Jul 04, 2025)

AstraZeneca Reports the EC’s Approval for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

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