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Definium Therapeutics Receives FDA Breakthrough Therapy Designation (BTD) for DT120 in MDD

Shots: Definium Therapeutics announced that the US FDA granted BTD to DT120 (lysergide) orally disintegrating tablet (ODT) for the treatment of major depressive disorder (MDD), following positive P-III results In the P-III Emerge study, a single 100 µg dose of DT120 ODT demonstrated an 8.1-point PBO-adjusted improvement in MADRS total score at wk. 6 (p<0.0001),…
September 8, 2026

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Rezubio Reports First Cohort Dosing in P-I Trial of RZ-520 Following FDA and NMPA IND Clearances

Shots: Rezubio has completed dosing of the first cohort in its P-I trial of RZ-520, following US FDA & Chinese NMPA clearances to assess its safety, tolerability, PK & PD in healthy volunteers RZ-520 is a clinical-stage asset developed using Rezubio’s MADD platform, with preclinical studies showing robust efficacy, superior safety & negligible systemic exposure…
September 7, 2026

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Acepodia Reports the US FDA IND Clearance to Initiate P-I Trial of ACE723 in HCC

Shots: The US FDA has granted IND clearance to ACE723 for the initiation of P-I trial to treat patients with unresectable or metastatic hepatocellular carcinoma (HCC) The P-I study will assess ACE723’s safety, tolerability, dose-limiting toxicities, PK & preliminary antitumor activity in above-mentioned pts, with dose-escalation portion of establishing recommended dose for further development &…
September 7, 2026

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AstraZeneca Receives the US FDA Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

Shots: FDA granted accelerated approval to Etcamah + a CDK4/6 inhibitor for HR+/HER2− LA/M breast cancer with an ESR1 mutation emerging during AI + CDK4/6 inhibitor therapy, alongside approval of a ctDNA-based CDx for detecting ESR1 resistance mutations Approval was based on the P-III (SERENA-6) trial assessing Etcamah + CDK4/6 inhibitor vs AI (anastrozole/letrozole) +…
September 7, 2026

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Heartvue.ai and Innolitics Receive FDA 510(k) Clearance for Heartvue.Proton

Shots: The US FDA has granted 510(k) clearance (K260811) to Heartvue.Proton, a machine learning-powered platform for viewing, post-processing & quantitative evaluation of cardiovascular MR images  The platform automates 2D linear dimensions, ventricular volumes & ejection fraction, and blood flow quantification, while keeping results under physician review. It integrates with hospital PACS & EHR systems to…
September 3, 2026

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uniQure Reports the US FDA BLA Submission for Ifezuntirgene Inilparvovec to Treat Huntington’s Disease

Shots: The US FDA has received a BLA for the accelerated approval of ifezuntirgene inilparvovec (AMT-130) for the treatment of Huntington’s disease, plus a request for Priority Review BLA was supported by the 3yr. data analysis from the P-I/II trial of AMT-130 vs a propensity score-matched external control derived from the Enroll-HD natural history database;…
September 2, 2026

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Medibyt Receives FDA 510(k) Clearance for CPETWise

Shots: The US FDA has granted 510(k) clearance to CPETWise (K260242) designed to streamline cardiopulmonary exercise testing (CPET) analysis, interpretation and reporting through a standardized clinical workflow The clearance follows a 100-case proof-of-concept study at the University of Washington, where CPETWise achieved an average user satisfaction score of 4.5/5 & cut interpretation time by more…
September 2, 2026

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CorTec Receives Second FDA Breakthrough Device Designation for Brain Interchange system

Shots: The US FDA has granted Breakthrough Device Designation to Brain Interchange system for communication in people with non-progressive quadriplegia, letting users to control a computer cursor through thought alone The new designation builds on Brain Interchange’s April 2026 BDD for stroke motor rehabilitation. The same implant can function therapeutically by stimulating the brain to…
September 1, 2026

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PharmaEssentia Reports the US FDA Approval of BESREMi (Ropeginterferon Alfa-2b-njft) for Essential Thrombocythemia

Shots: The US FDA has approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythemia (ET), expanding BESREMi product label beyond polycythemia vera Approval was supported by durable ELN responses and hematologic control in adults with ET. In P-III (SURPASS-ET) trial, it outperformed anagrelide in durable response rates & reduced thromboembolic events over…
September 1, 2026

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