The US FDA Grants 510(k) clearance to Stryker’s OptaBlate BVN System for Vertebrogenic Pain

Shots: The US FDA has granted 510(k) clearance to the OptaBlate BVN system for minimally invasive procedure designed to deliver long-lasting relief from vertebrogenic pain OptaBlate BVN achieves ≥1cm lesions in 7min. & features a steerable curved introducer, with microinfusion tech to minimize impedance & charring, plus 10-gauge access tools for precision OptaBlate BVN combines…

ByRidhi RastogiMay 20, 2025

NEWS

BioCryst Reports the US FDA’s NDA Acceptance and Priority Review of Orladeyo for Hereditary Angioedema (HAE)

Shots: The US FDA has accepted NDA & granted priority review to Orladeyo (berotralstat) for the treatment of HAE pts (2-11yrs.), with PDUFA action date of Sep 12, 2025. Line extension application has been filed with the EMA; further filings are planned globally incl. Japan & Canada NDA was supported by P-III (APeX-P) trial assessing Orladeyo…

ByRidhi RastogiMay 16, 2025

NEWS

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

Shots: The US FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for treatment-experienced pts with locally advanced or metastatic, c-Met overexpressing, non-squamous NSCLC Approval was backed by an ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L/3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84) with…

ByRidhi RastogiMay 16, 2025

NEWS

Median Technologies Seeks the US FDA’s 510(k) Clearance of eyonis LCS for Lung Cancer Detection

Shots: The US FDA has received application for 510(k) clearance of eyonis Lung Cancer Screening (LCS) to detect & diagnose lung cancer, with clearance expected in Q3'25 Submission is backed by 2 studies, REALITY & RELIVE, both of which met their 1EP; REALITY depicted an AUC of 0.904 (vs 0.80 threshold), accurately detecting early lung…

ByRidhi RastogiMay 14, 2025

NEWS

Cytokinetics Reports P-III (MAPLE-HCM) Trial Data of Aficamten for Obstructive Hypertrophic Cardiomyopathy

Shots: Cytokinetics has reported P-III (MAPLE-HCM) trial data assessing aficamten vs SoC metoprolol in pts (n=175) with symptomatic obstructive hypertrophic cardiomyopathy (HCM); regulatory review is ongoing in the US FDA (PDUFA: Dec 26, 2025) & EMA, with its NDA also under NMPA's priority review The trial met its 1EP, showing superior improvement in peak oxygen…

ByRidhi RastogiMay 14, 2025

INSIGHTS+

The US FDA New Drug Approvals in April 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of April 2025 The US FDA has approved a total of 3 new drug including 1 new molecular entity and 2 Biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Johnson & Johnson’s…

ByDipanshu DixitMay 13, 2025

NEWS

MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

Shots: The US FDA has approved IND application of MVX-220 for the treatment of Angelman Syndrome (AS) to initiate P-I/II (ASCEND-AS) trial, with first pts dosing expected in H2’25 The P-I/II trial will evaluate the safety, tolerability, & effectiveness of MVX-220 in both adult & pediatric pts with multiple AS genotypes, incl. rare types like uniparental…

ByRidhi RastogiMay 13, 2025

NEWS

Teal Health Reports the US FDA’s Approval of Teal Wand for Cervical Cancer Screening

Shots: The US FDA has approved Teal Wand to screen cervical cancer at-home for women (25-65yrs.); commercially available in California by Jun 2025, with further expansion worldwide Approval was based on SELF-CERV study, which showed Teal Wand detected cervical precancer 96% of the time, with 94% participants preferring at-home screening test if it was as…

ByRidhi RastogiMay 12, 2025

NEWS

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

Shots: The US FDA has received the IND application for UTRxM1-18, a novel therapy targeting c-MYC-driven cancers, to initiate P-I trial in 2026 pending approval, focusing on c-MYC driven tumors incl. triple-negative breast, pancreatic, colorectal, & ovarian cancer UTRxM1-18 has demonstrated strong, dose-dependent efficacy against human-derived tumors from multiple cancer subtypes, with no dose-limiting toxicities…

ByRidhi RastogiMay 9, 2025

NEWS

FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

Shots: This accelerated approval for the combination of Avmapki (avutometinib) + Fakzynja (defactinib) was granted in advance to the planned PDUFA of Jun 30, 2025, which will be available in the US within a week as a co-pack Approval was based on P-II (RAMP 201) trial assessing Avmapki (3.2mg, twice weekly) + Fakzynja (200 mg,…

ByDipanshu DixitMay 9, 2025

The US FDA Grants 510(k) clearance to Stryker’s OptaBlate BVN System for Vertebrogenic Pain

BioCryst Reports the US FDA’s NDA Acceptance and Priority Review of Orladeyo for Hereditary Angioedema (HAE)

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

Median Technologies Seeks the US FDA’s 510(k) Clearance of eyonis LCS for Lung Cancer Detection

Cytokinetics Reports P-III (MAPLE-HCM) Trial Data of Aficamten for Obstructive Hypertrophic Cardiomyopathy

The US FDA New Drug Approvals in April 2025

MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

Teal Health Reports the US FDA’s Approval of Teal Wand for Cervical Cancer Screening

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

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