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 cirrhosisLabel 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 Rastogi3 days ago

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+ NSCLCApproval was based on the P-II [TRUST-I (China) & TRUST-II (global)] studies assessing Ibtrozi monotx. in 173 & 164 pts with ROS1+ NSCLC, respectivelyTRUST-I showed a cORR of 90% in TKI-naïve pts, with longest DoR of 46.9mos. &…

ByRidhi Rastogi3 days ago

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 2026Preclinical 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 Giri4 days ago

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 Dixit4 days ago

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 Q4’25The approval was supported by two P-III global studies showing Widaplik significantly improved blood pressure and control rates vs PBO & dual drug combinationsWidaplik (GMRx2), a…

ByDipanshu Dixit4 days ago

INSIGHTS+

The US FDA New Drug Approvals in May 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2025 The US FDA has approved a total of 3 new drugs, including 2 new molecular entities and 1 Biologic leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was AbbVie’s Emrelis securing…

ByDipanshu Dixit5 days ago

News

TYBR Health’s B3 GEL System Receives the US FDA’s 510(k) Clearance to Protect Healing Tissue and Preserve Function

Shots:The US FDA has granted 510(k) clearance to the B3 GEL System to protect healing tissue planes and preserve mobility; launch is anticipated at the end of 2025Preclinical studies supporting clearance showed that B3 GEL reduced tissue binding and improved range of motion, with greater flexion and extension in treated models compared to controls…

ByDipanshu Dixit5 days ago

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 therapyNDA 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 therapyTrial showed improved PFS (1EP) by 43%…

ByRidhi RastogiJune 9, 2025

News

Otsuka Pharmaceutical Reports Interim P-III (VISIONARY) Trial Data of Sibeprenlimab for Immunoglobulin A Nephropathy (IgAN)

Shots:Otsuka Pharmaceutical has reported interim P-III (VISIONARY) trial data evaluating sibeprenlimab (400mg, SC, Q4W) vs PBO in ~510 IgAN pts, who were on SoC therapyTrial showed a 51.2% reduction in 24hr. uPCR (1EP) at 9mos. (presented at ERA 2025) & will continue to assess kidney function (2EP) via eGFR over 24mos., with completion…

ByRidhi RastogiJune 6, 2025

News

Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots:The US FDA has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts; approval process in the EU is ongoingApproval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT (n=446) vs PBO + ADT (n=223) in 669 mHSPC ptsTrial showed a 46% reduction in rPFS (1EP),…

ByRidhi RastogiJune 4, 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 New Drug Approvals in May 2025

TYBR Health’s B3 GEL System Receives the US FDA’s 510(k) Clearance to Protect Healing Tissue and Preserve Function

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

Otsuka Pharmaceutical Reports Interim P-III (VISIONARY) Trial Data of Sibeprenlimab for Immunoglobulin A Nephropathy (IgAN)

Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

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