MedPath

Eton Pharmaceuticals Receives FDA Approval for KHINDIVI, First Hydrocortisone Oral Solution for Pediatric Adrenal Insufficiency

5/29/2025

Eton Pharmaceuticals announced FDA approval of KHINDIVI (hydrocortisone) oral solution, marking the first and only FDA-approved liquid hydrocortisone formulation for pediatric patients aged 5 and older with adrenocortical insufficiency.

Delta-Fly Pharma Advances Solid Tumor and Pancreatic Cancer Programs

11/5/2024

Delta-Fly Pharma's DFP-14927, a drug delivery formulation of DFP-10917, is undergoing an expanded Phase I study in R/R colorectal cancer patients at MD Anderson and UCLA.

Recce Pharmaceuticals' R327G Shows 93% Efficacy in Phase II Trial for Bacterial Skin Infections

11/6/2024

Recce Pharmaceuticals' R327G topical gel achieved a 93% primary efficacy endpoint in treating acute bacterial skin and skin structure infections (ABSSSI) and diabetic foot infections (DFI).

Ocugen Doses First Patient in Phase 1 Trial of OCU200 for Diabetic Macular Edema

1/16/2025

Ocugen has initiated a Phase 1 clinical trial for OCU200, a novel integrin-targeting biologic, in patients with diabetic macular edema (DME).

Intas Pharmaceuticals Receives CDSCO Panel Approval for Phase III Trial of R-hFSH

11/10/2024

• Intas Pharmaceuticals has been granted permission by the CDSCO's Subject Expert Committee to proceed with a Phase III clinical trial for its R-hFSH solution for injection. • The trial will assess the safety, efficacy, and immunogenicity of Intas' R-hFSH compared to Merck Serono's Gonal-F in adult females undergoing assisted reproductive technology. • The CDSCO panel recommended including more tertiary care centers and government sites in the Phase III clinical trial to ensure a diverse study population. • R-hFSH, a recombinant human follicle-stimulating hormone, is crucial for ovarian follicular growth in women and spermatogenesis in men with specific hormonal deficiencies.

Zanidatamab Shows Promise in HER2-Positive Gastroesophageal and Colorectal Cancers

9/9/2024

Jazz Pharmaceuticals presented updated Phase 2 data at ESMO 2024 for zanidatamab plus chemotherapy in HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA).

Rocket Pharma Completes Enrollment in Phase 2 Trial of RP-A501 for Danon Disease

9/17/2024

Rocket Pharmaceuticals has completed enrollment in its Phase 2 pivotal trial of RP-A501 for male patients with Danon disease.

Enanta's EDP-323 Shows Strong Efficacy in RSV Human Challenge Trial

9/26/2024

Enanta Pharmaceuticals' EDP-323 demonstrated significant viral load reduction in a Phase 2a human challenge trial for Respiratory Syncytial Virus (RSV).

Alnylam's ALN-HTT02: First Patient Dosed in Phase 1 Huntington's Disease Trial

12/7/2024

Alnylam Pharmaceuticals initiated a Phase 1 clinical trial for ALN-HTT02, a novel RNAi therapeutic targeting the huntingtin (HTT) gene for Huntington's disease (HD).

Kira Pharmaceuticals' KP104 Shows Sustained Efficacy and Safety in PNH Phase 2 Trial

12/11/2024

KP104, a dual-targeting complement inhibitor, demonstrates long-term safety and efficacy in complement inhibitor-naïve PNH patients.

Identiv and Novanta Partner to Advance RFID Technology in Medical Devices and Pharmaceuticals

2/5/2025

Identiv and Novanta have formed a strategic partnership to develop integrated RFID solutions for medical device manufacturers, combining Identiv's RFID inlays with Novanta's ThingMagic reader technology.

Senores Pharmaceuticals Acquires 14 ANDAs from Dr. Reddy's in $421M Market Opportunity Deal

3/4/2025

Gujarat-based Senores Pharmaceuticals has strategically acquired 14 Abbreviated New Drug Applications from Dr. Reddy's Laboratories, with 13 already FDA-approved and one pending approval.

Processa Pharmaceuticals Doses First Patient in Phase II Trial of NGC-Cap for Metastatic Breast Cancer

10/2/2024

Processa Pharmaceuticals has dosed the first patient in a Phase II clinical trial of Next Generation Capecitabine (NGC-Cap) for advanced or metastatic breast cancer.

Ganaxolone Shows Promise in Phase III RAISE Trial for Refractory Status Epilepticus

10/17/2024

Marinus Pharmaceuticals' RAISE trial evaluated IV ganaxolone for refractory status epilepticus (RSE), meeting one co-primary endpoint.

Arrowhead Pharmaceuticals Launches First-in-Human Trial of ARO-ALK7 for Obesity Treatment

6/2/2025

Arrowhead Pharmaceuticals has dosed the first subjects in a Phase 1/2a clinical trial of ARO-ALK7, marking the first investigational RNAi therapeutic to target a gene expressed in adipose tissue for obesity treatment.

Rhythm Pharmaceuticals' Imcivree Shows Significant Weight Loss in Phase III Hypothalamic Obesity Trial

4/7/2025

Rhythm Pharmaceuticals' Imcivree (setmelanotide) demonstrated a 19.8% placebo-adjusted reduction in BMI over 52 weeks in patients with acquired hypothalamic obesity, a rare condition caused by hypothalamic damage.

Meitheal Pharmaceuticals Launches Generic Abraxane in US Market to Address Cancer Treatment Access

5/31/2025

Meitheal Pharmaceuticals has launched paclitaxel protein-bound particles for injectable suspension, a generic version of Abraxane, through an exclusive licensing agreement with parent company Hong Kong King-Friend Industry.

GSK Acquires Efimosfermin Alfa from Boston Pharmaceuticals in $2 Billion Deal for Liver Disease Treatment

5/14/2025

GSK has agreed to acquire efimosfermin alfa, a phase III-ready liver disease drug, from Boston Pharmaceuticals in a deal worth up to $2 billion.

Foresee Pharmaceuticals Redirects Mirivadelgat Development to PH-ILD Following Fanconi Anemia Trial Challenges

2/28/2025

Foresee Pharmaceuticals has terminated its Phase 2 trial of mirivadelgat for Fanconi anemia due to significant patient recruitment challenges and shifting research priorities in the field.

Rivus Pharmaceuticals' HU6 Shows Muscle-Sparing Weight Loss in HFpEF Trial

9/23/2024

Rivus Pharmaceuticals' HU6 demonstrated statistically significant reductions in fat mass and visceral fat in obese patients with heart failure with preserved ejection fraction (HFpEF).

© Copyright 2025. All Rights Reserved by MedPath