NEWS

Abbott’s TactiFlex Duo Ablation Catheter Secures FDA Approval for Atrial Fibrillation

Shots: The US FDA has approved TactiFlex Duo Ablation Catheter, Sensor Enabled to treat patients with challenging cases of atrial fibrillation (AFib) Approval was based on the results from Abbott's FlexPulse IDE study, with data recently presented at the ESC’26 & simultaneously published in EPEuropace, showing favorable safety & effectiveness outcomes in pts with paroxysmal AFib TactiFlex Duo delivers…

September 9, 2026

Amgen and AstraZeneca Report the P-III (DeLLphi-305) Trial Data on Imfinzi + Imdelltra for 1L ES-SCLC

Shots: Amgen & AZ have reported the P-III (DeLLphi-305) trial data assessing Imfinzi + Imdelltra vs Imfinzi as the 1L maintenance treatment for pts (n=563) with ES-SCLC who have not progressed following induction treatment with Imfinzi + PT-based CT & etoposide Trial showed improved OS (1EP) & demonstrated benefits across 2EPs, incl. PFS & ORR;…

September 9, 2026

AstraZeneca Reports P-III OBERON and TITANIA Results for Tozorakimab in COPD at ERS’26

Shots: AstraZeneca reported full results from the P-III OBERON and TITANIA studies, showing that tozorakimab 300 mg Q4W reduced moderate-to-severe COPD exacerbations versus PBO in pts. receiving inhaled standard of care In the primary population of former smokers, tozorakimab reduced exacerbations by 29% in OBERON and 34% in TITANIA, while reductions in the overall population…

September 8, 2026

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

Belite Bio Submits NDA to Japan’s MHLW for Tinlarebant in Stargardt Disease Type 1

Shots: Belite Bio submitted a New Drug Application (NDA) to Japan’s MHLW for once-daily oral tinlarebant (LBS-008) for the treatment of Stargardt disease type 1 (STGD1) The NDA was submitted under Japan’s Sakigake Designation System, following tinlarebant’s designation as a Sakigake pharmaceutical product; if approved, it could become the first approved treatment for STGD1 and…

September 8, 2026

Novartis Reports del-desiran P-III HARBOR Study Data in Myotonic Dystrophy Type 1

Shots: Novartis announced that the P-III HARBOR study of delpacibart etedesiran (del-desiran) in people with myotonic dystrophy type 1 (DM1) did not meet its 1EP of video hand opening time (vHOT) Del-desiran showed evidence of clinical activity in 2EPs and exploratory analyses, while safety findings were generally consistent with previously reported data; Novartis is evaluating…

September 8, 2026

Upstream Bio Reports P-II VALIANT Data for Verekitug in Severe Asthma

Shots: Upstream Bio presented results from the P-II VALIANT study evaluating verekitug in 478 adults with severe asthma, with the study meeting its 1EP of reducing the annualized asthma exacerbation rate (AAER) across all dose regimens. Verekitug 100 mg dosed every 12 wks. reduced AAER by 56% vs. PBO (p<0.001) and also improved lung function…

September 8, 2026

Nyxoah Implants First Patient in BREATHE US Post-Approval Study of Genio System

Shots: Nyxoah announced the first patient implantation in BREATHE, its US post-approval study evaluating the long-term safety and effectiveness of the Genio System in adults with moderate to severe obstructive sleep apnea (OSA) The prospective, multicenter study plans to implant up to 229 pts. across up to 25 US centres, with follow-up for up to…

September 8, 2026

Aptar and Aceso Therapeutics Collaborate to Advance Inhaled ASO Therapy for Cystic Fibrosis

Shots: Aptar Pharma and Aceso Therapeutics have entered into a collaboration to advance ACT-101, an antisense oligonucleotide (ASO) candidate designed to target underlying disease mechanisms of cystic fibrosis (CF) Aptar Pharma’s specialist inhalation development services business; Nanopharm will lead formulation development and device assessment activities to support clinical development of ACT-101 The collaboration combines Nanopharm’s…

September 8, 2026

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

NEWS

Abbott’s TactiFlex Duo Ablation Catheter Secures FDA Approval for Atrial Fibrillation

Amgen and AstraZeneca Report the P-III (DeLLphi-305) Trial Data on Imfinzi + Imdelltra for 1L ES-SCLC

AstraZeneca Reports P-III OBERON and TITANIA Results for Tozorakimab in COPD at ERS’26

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

Belite Bio Submits NDA to Japan’s MHLW for Tinlarebant in Stargardt Disease Type 1

Novartis Reports del-desiran P-III HARBOR Study Data in Myotonic Dystrophy Type 1

Upstream Bio Reports P-II VALIANT Data for Verekitug in Severe Asthma

Nyxoah Implants First Patient in BREATHE US Post-Approval Study of Genio System

Aptar and Aceso Therapeutics Collaborate to Advance Inhaled ASO Therapy for Cystic Fibrosis

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

Contact US

FOLLOW US