The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Shots: FDA has approved sNDA of Zoryve (0.3% roflumilast) for pts (≥12yrs.) with plaque PsO of scalp & body based on P-III (ARRECTOR) & P-II (Trial 204) trials assessing it vs vehicle in 736 pts for 8wks. ARRECTOR met its co-1EPs, with 66.4% vs 27.8% pts achieving Scalp-IGA success & 45.5% vs 20.1% pts attaining…

ByRidhi RastogiMay 23, 2025

NEWS

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy

Shots: The US FDA has approved Susvimo (port delivery platform with Lucentis) for the treatment of diabetic retinopathy (DR) Approval was based on 1 yr. P-III (Pavilion) trial data assessing Susvimo (100mg/mL, refilled Q9M) vs monthly clinical observation in 173 pts with non-proliferative DR without center-involved DME, where subjects in Susvimo arm received 2 loading…

ByRidhi RastogiMay 23, 2025

NEWS

GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Shots: The US FDA has approved Nucala as an add-on treatment for inadequately controlled COPD & eosinophilic phenotype based on the P-III (MATINEE & METREX) trial; EMA & NMPA’s submissions are under review MATINEE assessed Nucala (n=403; 100mg, SC, Q4W) vs PBO (n=401) in COPD pts (n=804) with type 2 inflammation while METREX evaluated it…

ByRidhi RastogiMay 23, 2025

NEWS

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Shots: FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg) & autoinjectors (40 & 80mg) expanding on the prior designation for the 20mg & 80mg prefilled syringes Designation was based on P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev.…

ByRidhi RastogiMay 22, 2025

NEWS

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

The US FDA Approves Arcutis Biotherapeutics’ Zoryve Topical Foam for Plaque Psoriasis

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Retinopathy

GSK Reports the US FDA’s Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

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

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