Sunrise Group Wins the US FDA Clearance for Sunrise Air Home Sleep Apnea Test

Shots: The US FDA has granted clearance to Sunrise Air, an at-home sleep apnea diagnostic platform designed to expand access to sleep care through a fully home-based testing solution, following a $29M funding round The lightweight, rechargeable device is built around the company’s mandibular jaw movement (MJM) tech, which captures chin movement signals & uses…

ByRidhi Rastogi3 days ago

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Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC

Shots: The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo…

ByRidhi Rastogi4 days ago

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Accord BioPharma Reports the US FDA Approval of Immgolis and Immgolis Intri (Biosimilar, Simponi and Simponi Aria)

Shots: The US FDA has approved Immgolis & Immgolis Intri, the interchangeable biosimilar versions of Simponi & Simponi Aria (golimumab), respectively Immgolis & Immgolis Intri are both approved for the treatment of adults with mod. to sev. active rheumatoid arthritis in combination with methotrexate, while Immgolis is additionally approved for mod. to sev. active ulcerative…

ByRidhi Rastogi4 days ago

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AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension

Shots: The US FDA has approved AstraZeneca's Baxfendy in combination with other antihypertensive medications for the treatment of pts with uncontrolled or treatment-resistant hypertension Approval was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment-resistant hypertension Trial met…

ByRidhi Rastogi5 days ago

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Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment

Shots: FDA approved Genentech's Tecentriq & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) as an adj. therapy for adults with MIBC who have ctDNA MRD after cystectomy, as identified by Natera’s Signatera CDx MRD assay, which received simultaneous FDA approval Approval was based on the P-III (IMvigor011) trial evaluating Tecentriq vs PBO in adults with MIBC & ctDNA…

ByRidhi Rastogi5 days ago

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AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Approval in Early Breast Cancer for Two Indications

Shots: FDA has approved Enhertu + THP for neoadj. treatment of adults with HER2+ Stage II/III breast cancer, & Enhertu monotx. for adj. treatment in adults with residual invasive disease post Herceptin (± Perjeta) & taxane-based therapy, triggering a $155M milestone payment from AZ to Daiichi Sankyo For neoadj. setting, approval was backed by DESTINY-Breast11…

ByRidhi Rastogi5 days ago

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Glooko Secures FDA Clearance for Cloud-Based EndoTool IV Insulin Dosing Platform

Shots: The US FDA has granted 510(k) clearance for EndoTool IV Cloud, a cloud-based patient-specific insulin dosing platform designed for hospitalized pts requiring IV insulin therapy Built on the same dosing algorithm as EndoTool IV, the cloud-based platform is designed to support individualized insulin dosing while enabling more scalable implementation, streamlined maintenance, & reduced reliance…

ByRidhi RastogiMay 15, 2026

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AstraZeneca’s Fasenra Receives the US FDA Approval for Hypereosinophilic Syndrome

Shots: The US FDA has approved AstraZeneca's Fasenra (benralizumab) for the treatment of pts (≥12yrs.) with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause Approval was based on the P-III (NATRON) trial data assessing Fasenra (30mg, SC, Q4W) vs PBO, both in addition to background HES therapy in 133 HES pts for 24wks. Trial met…

ByRidhi RastogiMay 15, 2026

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Revvity Receives FDA Clearance for Total Testosterone ChLIA Assay

Shots: Revvity has received the US FDA clearance for its Total Testosterone automated chemiluminescence immunoassay (ChLIA), expanding its endocrine diagnostics portfolio The portfolio enables direct ChLIA measurement of total testosterone, SHBG, & free testosterone, supporting both first & second-line diagnostic testing for suspected male hypogonadism Processed on IDS’ random-access automation platforms, the expanded portfolio enables…

ByRidhi RastogiMay 14, 2026

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Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA Approval of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has approved Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, who are 75yrs. or older, or ineligible for intensive induction CT Approval was backed by P-II (ASCERTAIN-V) trial in adults with newly diagnosed AML ineligible for intensive induction CT Trial showed a…

ByRidhi RastogiMay 14, 2026

Sunrise Group Wins the US FDA Clearance for Sunrise Air Home Sleep Apnea Test

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC

Accord BioPharma Reports the US FDA Approval of Immgolis and Immgolis Intri (Biosimilar, Simponi and Simponi Aria)

AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension

Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment

AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Approval in Early Breast Cancer for Two Indications

Glooko Secures FDA Clearance for Cloud-Based EndoTool IV Insulin Dosing Platform

AstraZeneca’s Fasenra Receives the US FDA Approval for Hypereosinophilic Syndrome

Revvity Receives FDA Clearance for Total Testosterone ChLIA Assay

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA Approval of Inqovi + Venetoclax for Newly Diagnosed AML

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