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FDA Drug Approvals May 2025
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…
June 10, 2025

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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 2025 Preclinical 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…
June 10, 2025

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Arvinas and Pfizer
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%…
June 9, 2025

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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 therapy Trial 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…
June 6, 2025

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Bayer
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 ongoing Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT (n=446) vs PBO + ADT (n=223) in 669 mHSPC pts Trial showed a 46% reduction in rPFS (1EP),…
June 4, 2025

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Moderna
NEWS

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…
June 3, 2025

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Reflow Medical
NEWS

Reflow Medical’s Spur Peripheral Retrievable Stent System Receives the US FDA’s De Novo Clearance for BTK-CLTI Treatment

Shots: FDA has granted De Novo clearance to the Spur Stent System for treating de novo or restenotic lesions post-predilatation in pts with infrapopliteal arterial disease In recently concluded DEEPER REVEAL trial (n=130), the system achieved 99.2% technical success rate & 97% freedom from MALE & POD at 30 days post-predilatation for below-the-knee (BTK) treatment…
May 30, 2025

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Samsung Bioepis and Organon
NEWS

Samsung Bioepis and Organon’s Hadlima (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Shots: FDA has granted interchangeability designation to Hadlima, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg/0.4mL) & autoinjectors (40mg/0.4mL & 40mg/0.8mL) expanding on the prior designation for prefilled syringe (40mg/0.8mL) & single-dose vial Designation was based on trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. plaque PsO…
May 28, 2025

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Gyre Therapeutics
NEWS

Gyre Therapeutics Releases P-III Trial Findings on Hydronidone for Chronic Hepatitis B-Associated Liver Fibrosis

Shots: Gyre Therapeutics has reported P-III trial data assessing Hydronidone (270mg, QD, PO) + entecavir (n=123) vs PBO + entecavir (n=124) in 248 Chinese pts with chronic hepatitis B-associated liver fibrosis for 52wks.; 1 untreated subject was excluded from analysis Trial met its 1EP, with 52.85% vs 29.84% achieving ≥1-stage fibrosis regression (Ishak score) & 2EP,…
May 23, 2025

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