Myriad Genetics Receives the US FDA Approval for MyChoice CDx Test as a Companion Diagnostic for GSK’s Zejula

Shots: The US FDA has approved MyChoice CDx Test as a companion diagnostic for for HRD+ identification in pts with advanced ovarian cancer who may benefit from treatment with Zejula (niraparib) Approval was based on the PRIMA trial assessing Zejula vs PBO in ovarian cancer pts with complete or partial response to 1L Pt-based CT,…

ByRidhi RastogiMarch 18, 2026

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Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for NonAdvanced Systemic Mastocytosis (NonAdvSM)

Shots: The US FDA has accepted the NDA of bezuclastinib for the treatment of NonAdvSM, with no advisory committee meeting planned or review issues identified yet (PDUFA: Dec 30, 2026) NDA was backed by SUMMIT trial, which met its 1 & 2EPs, showing sustained, deepening clinical benefit through 48wks., plus impact on bone mineral density…

ByRidhi RastogiMarch 18, 2026

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Prodeon Medical Secures FDA Clearance for Urocross Expander System to Treat Urinary Symptoms Associated with BPH

Shots: The US FDA has granted 510(k) clearance to the Urocross Expander System for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), backed by extensive data incl. the Expander-1 & Expander-2 trials Expander-2 (n=240) showed mean 48.1% IPSS improvement & a 74.5% responder rate (≥30% IPSS reduction) at 12mos. post implantation…

ByRidhi RastogiMarch 17, 2026

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Novartis Reports the US FDA Approval of Cosentyx for Pediatric Patients with Hidradenitis Suppurativa

Shots: The US FDA has approved Cosentyx(secukinumab) for the treatment of pts (≥12yrs., ≥30kg) with mod. to sev. hidradenitis suppurativa Approval was supported by adult clinical studies, PK modeling extrapolated from adult HS & psoriasis trials, pediatric trial data from other approved indications, & dosing analyses that showed weight-based pediatric dosing achieves exposure comparable to…

ByRidhi RastogiMarch 16, 2026

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GSK Receives the US FDA Approval of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The US FDA has approved Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for lower respiratory tract disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing immune response & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was…

ByRidhi RastogiMarch 13, 2026

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Insulet Reports EVOLUTION 2 Study Results for FCL Automated Insulin Delivery System in Type 2 Diabetes

Shots: Insulet has presented data from the EVOLUTION 2C feasibility study (n=24, 16-70yrs.) assessing its fully closed-loop (FCL) automated insulin delivery system (AID) for T2D at the ATTD’26 Trial showed that the final FCL algorithm increased TIR to an average of 68% with no boluses, a 24% improvement vs standard injection therapy, while TBR remained…

ByRidhi RastogiMarch 12, 2026

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Cairn Surgical Reports the FDA De Novo 510(k) Submission for BCL System to Improve Accuracy of Lumpectomy

Shots: The US FDA has received a De Novo 510(k) application for the Breast Cancer Locator (BCL) System to improve the accuracy of breast-conserving surgery (lumpectomy) Cairn Surgical completed its US pivotal trial of the system, with data to be presented at the ASBrS’26 & incl. in the FDA filing, along with earlier data, published…

ByRidhi RastogiMarch 12, 2026

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ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

Shots: The US FDA has granted FTDto ATX-01 for the treatment of Myotonic Dystrophy Type 1 (DM1) ATX-01 showed increased free MBNL, improved splicing abnormalities, & restored function in animal models, & is being evaluated in the P-I/IIa (ArthemiR) study ATX-01 is an RNA-based therapeutic designed to inhibit miR-23b, which results in increased MBNL protein…

ByRidhi RastogiMarch 11, 2026

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QIAGEN Wins the US FDA Clearance for QIAstat-Dx GI Panels on QIAstat-Dx Rise Syndromic Testing System

Shots: The US FDA has cleared all QIAstat-Dx GI Panels for use on the QIAstat-Dx Rise automated syndromic testing system The clearance enables laboratories to run both GI and respiratory panels on the high-throughput platform, which can process up to 160 tests/day, run 16 samples per batch, and deliver results in ~1hr. using real-time PCR…

ByRidhi RastogiMarch 11, 2026

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AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Priority Review for HER2+ Early Breast Cancer

Shots: FDA has granted priority review to Enhertu’s sBLA for adults with HER2+ breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment, with submission to be reviewed under Project Orbis (PDUFA: Q3’26); review is also ongoing in the EU & Japan sBLA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu…

ByRidhi RastogiMarch 9, 2026

Myriad Genetics Receives the US FDA Approval for MyChoice CDx Test as a Companion Diagnostic for GSK’s Zejula

Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for NonAdvanced Systemic Mastocytosis (NonAdvSM)

Prodeon Medical Secures FDA Clearance for Urocross Expander System to Treat Urinary Symptoms Associated with BPH

Novartis Reports the US FDA Approval of Cosentyx for Pediatric Patients with Hidradenitis Suppurativa

GSK Receives the US FDA Approval of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Insulet Reports EVOLUTION 2 Study Results for FCL Automated Insulin Delivery System in Type 2 Diabetes

Cairn Surgical Reports the FDA De Novo 510(k) Submission for BCL System to Improve Accuracy of Lumpectomy

ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

QIAGEN Wins the US FDA Clearance for QIAstat-Dx GI Panels on QIAstat-Dx Rise Syndromic Testing System

AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Priority Review for HER2+ Early Breast Cancer

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