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

NEWS

NMPA Accepts Marketing Authorization for Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: The NMPA has accepted the MAA of Pimicotinib (QD) for adults with TGCT needing systemic therapy The application was based on Part 1 of the P-III (MANEUVER) global study, trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment, the trial also…

ByDipanshu DixitJune 10, 2025

NEWS

Alnylam Pharmaceuticals’ Amvuttra Receives the EC’s Approval for ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Shots: The EC has approved Amvuttra (vutrisiran) to treat ATTR-CM adults as an additional indication, based on the global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts The study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved outcomes of mortality, CV events & functional capacity with 6min. walk…

ByDipanshu DixitJune 10, 2025

NEWS

Italfarmaco Obtains the EC’s Conditional Approval for Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Shots: The EC has granted conditional approval to Duvyzat (givinostat) for the treatment of ambulant DMD pts (≥6yrs.) on corticosteroids, regardless of underlying genetic mutation in all 30 EEA states Approval was based on the P-III (EPIDYS) study assessing Duvyzat (BID) vs PBO in ambulant DMD boys (n=179) on corticosteroid therapy Trial met its 1EP…

ByRidhi RastogiJune 9, 2025

NEWS

Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer

Shots: FDA has received NDA of vepdegestrant (ARV-471) to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy NDA was backed by P-III (VERITAC-2) trial assessing ARV-471 alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapy Trial showed improved PFS (1EP) by 43%…

ByRidhi RastogiJune 9, 2025

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

NMPA Accepts Marketing Authorization for Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Alnylam Pharmaceuticals’ Amvuttra Receives the EC’s Approval for ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Italfarmaco Obtains the EC’s Conditional Approval for Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer

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