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

Shots: The US FDA has received 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. term neonates; MAA was submitted to MHLW with further filings planned in coming mos. NDA was supported by the QUANTI clinical program, which incl. 2…

ByRidhi RastogiJune 18, 2025

NEWS

CSL Receives the US FDA Approval for Andembry as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The US FDA has approved Andembry (garadacimab-gxii) for HAE pts (≥12yrs); commercially available before Jun 2025 end Approval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean, as well as attacks requiring…

ByRidhi RastogiJune 17, 2025

NEWS

Averoa Receives the EC’s Approval for Xoanacyl to Treat Chronic Kidney Disease

Shots: The EC has approved Xoanacyl (ferric citrate complex) for chronic kidney disease; UK's MAA was filed via MHRA's IRP Approval was supported by 3 pivotal trials conducted by Akebia Therapeutics, which showed increased iron levels along with reduction in serum phosphorus in CKD pts Averoa licensed Xoanacyl from Akebia in Dec 2022, enhancing its…

ByRidhi RastogiJune 16, 2025

NEWS

Merck Receives the US FDA’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: The US FDA has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC based on P-III (KEYNOTE-689) trial Trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ± cisplatin vs…

ByRidhi RastogiJune 16, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jun 09, 2025 – Jun 13, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar & Animal Health. Check out our full report below:  Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN Read More: Apellis Pharmaceuticals and Sobi Daiichi Sankyo Reports First Patient…

ByRidhi RastogiJune 13, 2025

NEWS

UroGen Pharma Receives the US FDA’s Approval for Zusduri to Treat LG-IR-NMIBC

Shots: The US FDA has approved Zusduri (mitomycin) for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC); expected to be available in the US by Jul 1, 2025 Approval was based on P-III (ENVISION) trial assessing Zusduri (QW, intravesical) in ~240 LG-IR-NMIBC pts across 56 sites, which showed 78% pts…

ByRidhi RastogiJune 13, 2025

NEWS

Moderna’s mRESVIA Receives the US FDA’s Approval for Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has approved mRESVIA (mRNA-1345) to prevent lower respiratory tract disease caused by RSV in individuals (18-59yrs.) at risk; expected to be available in US for the 2025–2026 respiratory virus season Approval was based on P-III trial assessing safety & immunogenicity of mRESVIA in adults (18-59yrs.) at increased risk for RSV-associated lower…

ByRidhi RastogiJune 13, 2025

NEWS

AbbVie’s Mavyret Receives the US FDA’s Approval for Acute Hepatitis C Virus

Shots: The US FDA has approved label expansion of Mavyret (glecaprevir/pibrentasvir) to treat pts (≥3yrs.) with acute or chronic HCV infection, without cirrhosis or with compensated cirrhosis Label expansion was supported by P-III (M20-350) trial assessing Mavyret (QD, PO) in 286 treatment-naïve adults with acute HCV infection for 8wks. & then followed for 12wks. Trial…

ByRidhi RastogiJune 12, 2025

NEWS

Nuvation Bio Reports the US FDA’s Approval of Ibtrozi to Treat Advanced ROS1+ NSCLC

Shots: The US FDA has approved Ibtrozi (taletrectinib) for treating locally advanced or metastatic ROS1+ NSCLC Approval was based on the P-II [TRUST-I (China) & TRUST-II (global)] studies assessing Ibtrozi monotx. in 173 & 164 pts with ROS1+ NSCLC, respectively TRUST-I showed a cORR of 90% in TKI-naïve pts, with longest DoR of 46.9mos. &…

ByRidhi RastogiJune 12, 2025

NEWS

Nuevocor Reports the US FDA’s IND Clearance of NVC-001 for LMNA DCM

Shots: The US FDA has approved the IND application of NVC-001 to treat LMNA-related dilated cardiomyopathy (LMNA DCM), enabling a P-I/II trial to start in early 2026 Preclinical studies showed that NVC-001 significantly improved survival and cardiac function. They planned a P-I/II trial, a 52-week, open-label, multicenter ascending-dose study to assess the safety, tolerability, and…

ByPrince GiriJune 11, 2025

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

CSL Receives the US FDA Approval for Andembry as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Averoa Receives the EC’s Approval for Xoanacyl to Treat Chronic Kidney Disease

Merck Receives the US FDA’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

PharmaShots Weekly Snapshots (Jun 09, 2025 – Jun 13, 2025)

UroGen Pharma Receives the US FDA’s Approval for Zusduri to Treat LG-IR-NMIBC

Moderna’s mRESVIA Receives the US FDA’s Approval for Respiratory Syncytial Virus (RSV) Disease

AbbVie’s Mavyret Receives the US FDA’s Approval for Acute Hepatitis C Virus

Nuvation Bio Reports the US FDA’s Approval of Ibtrozi to Treat Advanced ROS1+ NSCLC

Nuevocor Reports the US FDA’s IND Clearance of NVC-001 for LMNA DCM

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