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

NEWS

Jazz Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Zepzelca + Atezolizumab for ES-SCLC

Shots: The US FDA has accepted sNDA & granted priority review seeking full approval of Zepzelca (lurbinectedin) + atezolizumab (Tecentriq) as a 1L therapy for ES-SCLC patients whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide (PDUFA: Oct 07, 2025) The sNDA was based on P-III (IMforte) trial results, showing Zepzelca +…

ByDipanshu DixitJune 11, 2025

NEWS

The US FDA Approves George Medicines’ Widaplik for Hypertension in Adults

Shots: George Medicines’ Widaplik (telmisartan, amlodipine, and indapamide) has been approved by the US FDA for treating adult hypertension, including as initial therapy; launch is anticipated in Q4’25 The approval was supported by two P-III global studies showing Widaplik significantly improved blood pressure and control rates vs PBO & dual drug combinations Widaplik (GMRx2), a…

ByDipanshu DixitJune 11, 2025

NEWS

The US FDA Approves Merck’s ENFLONSIA for RSV Prevention in Infants

Shots : Merck’s ENFLONSIA has been approved by the US FDA to prevent RSV lower respiratory tract disease in newborns and infants entering their first RSV season, offering protection for up to 5mos. with a single 105mg dose, regardless of weight The approval was supported by the P-IIb/III (CLEVER) study of ENFLONSIA that demonstrated reduced…

ByDipanshu DixitJune 10, 2025

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

Jazz Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Zepzelca + Atezolizumab for ES-SCLC

The US FDA Approves George Medicines’ Widaplik for Hypertension in Adults

The US FDA Approves Merck’s ENFLONSIA for RSV Prevention in Infants

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