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

NEWS

Zymeworks’ Zanidatamab Receives the NMPA’s Conditional Approval for the Treatment of Biliary Tract Cancer

Shots: The NMPA has granted conditional approval to zanidatamab for the treatment of pts with previously treated, inoperable or metastatic HER2+ biliary tract cancer (BTC) following the CHMP’s positive opinion in Apr 2025 Approval was based on P-IIb (HERIZON-BTC-01) trial, which assessed anti-tumor activity of zanidatamab monotx. in HER2+ inoperable & advanced or metastatic BTC Approval…

ByRidhi RastogiMay 30, 2025

NEWS

Alcon Reports the US FDA’s Approval of Tryptyr to Treat Dry Eye Disease

Shots: The US FDA has approved Tryptyr (0.003% acoltremon ophthalmic solution; AR-15512) to treat signs & symptoms of dry eye disease (DED); US launch expected in Q3’25 Approval was backed by 2 P-III (COMET-2 & COMET-3) trials assessing Tryptyr vs vehicle in >930 pts with DED, where Tryptyr showed ≥10mm natural tear production increase by…

ByRidhi RastogiMay 29, 2025

NEWS

The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

Shots: The US FDA has granted priority review to sevabertinib (BAY 2927088; reversible TKI) for the treatment of previously treated pts with advanced NSCLC harboring HER2 mutations Designation was based on the P-I/II (SOHO-01) trial assessing (20mg, BID, PO) in HER2-mutant NSCLC, with data previously reported from 2 cohorts: pts progressing on ≥1 systemic therapy who…

ByRidhi RastogiMay 29, 2025

INSIGHTS+

New Drug Designations – April 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 April 2025 report covers designations granted to 36 drugs and 6 medical devices, spanning 14 small molecules, 3 biologics, 11 cell and gene therapies & 6 medical devices among…

ByRidhi RastogiMay 27, 2025

NEWS

AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

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

ByRidhi RastogiMay 27, 2025

NEWS

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Shots: The NMPA has approved telitacicept for the treatment of AChR antibody-positive gMG in combination with standard therapies In P-III trial for gMG, telitacicept demonstrated favorable efficacy vs PBO, with 98.1% vs 12% pts achieving ≥3-point MG-ADL reduction (-5.74 vs -0.91) as well as 87% vs 16% pts having ≥5-point QMG reduction (-8.66 vs -2.27) at…

ByRidhi RastogiMay 27, 2025

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)

Zymeworks’ Zanidatamab Receives the NMPA’s Conditional Approval for the Treatment of Biliary Tract Cancer

Alcon Reports the US FDA’s Approval of Tryptyr to Treat Dry Eye Disease

The US FDA Grants Priority Review to Bayer’s Sevabertinib for HER2-mutant NSCLC

New Drug Designations – April 2025

AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

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