MedPath

FDA Approves ANI Pharmaceuticals' Cortrophin Gel Prefilled Syringe for Multiple Autoimmune Conditions

3/3/2025

ANI Pharmaceuticals receives FDA approval for a new prefilled syringe format of Cortrophin Gel, available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options.

Eton Pharmaceuticals' ET-400 (Hydrocortisone Oral Solution) Receives FDA Acceptance

7/15/2024

Eton Pharmaceuticals' New Drug Application (NDA) for ET-400, an oral hydrocortisone solution, has been accepted by the FDA.

Madrigal Pharmaceuticals' Rezdiffra Sees Strong Uptake and Expansion Potential in MASH Treatment

11/23/2024

Madrigal Pharmaceuticals' Rezdiffra, the first FDA-approved treatment for MASH, is experiencing rapid sales growth, with over 6,800 patients on treatment in Q3 2024.

Tonix Pharmaceuticals' TNX-102 SL Demonstrates Positive Phase 3 Results in Fibromyalgia

11/19/2024

Tonix Pharmaceuticals announced positive Phase 3 topline results for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in fibromyalgia, meeting the pre-specified primary endpoint.

Phio Pharmaceuticals' PH-762 Shows Complete Tumor Clearance in Skin Cancer Trial

1/14/2025

Phio Pharmaceuticals reports two patients with cutaneous squamous cell carcinoma achieved complete tumor clearance in a Phase 1b trial of PH-762.

GLP-1 Agonist Market Set for Exponential Growth, Fueled by Novel Therapies and Expanding Indications

12/9/2024

The GLP-1 agonists market is projected to experience substantial growth by 2034, driven by increased awareness and efficacy in managing diabetes and obesity.

Acurx Pharmaceuticals Announces Positive Trial Results for Ibezapolstat

10/2/2024

Acurx Pharmaceuticals reported promising trial results for ibezapolstat, a novel antibiotic targeting Gram-positive bacteria, including Clostridioides difficile.

Acurx Pharmaceuticals Advances Ibezapolstat for C. difficile Infection

11/13/2024

Acurx Pharmaceuticals presented Phase 2 clinical trial results of ibezapolstat for *C. difficile* infection (CDI) at the Anaerobe Society of the Americas, highlighting its clinical efficacy.

Femasys Receives FDA Clearance for FemChec Fallopian Tube Diagnostic

9/9/2024

Femasys Inc. has received FDA 510(k) clearance for FemChec, a diagnostic solution designed for checking the fallopian tubes using controlled contrast delivery.

Izokibep Shows Positive Phase 3 Results in Hidradenitis Suppurativa

9/20/2024

Acelyrin's izokibep demonstrated statistically significant and clinically meaningful responses in a Phase 3 trial for moderate-to-severe hidradenitis suppurativa (HS).

Sana Biotechnology Faces Investigation Over Program Suspension and Stock Drop

11/19/2024

Pomerantz Law Firm is investigating Sana Biotechnology for potential securities fraud related to the suspension of its SC291 and SC379 programs.

Incannex Healthcare Announces Positive Clinical Trial Results and Financial Updates

10/1/2024

Incannex Healthcare reported positive Phase 2 results for PSX-001 in treating generalized anxiety disorder (GAD), showing significant anxiety reduction with synthetic psilocybin and psychotherapy.

Penumbra Completes Enrollment in THUNDER Study for Acute Ischemic Stroke

10/15/2024

Penumbra, Inc. has completed enrollment in its THUNDER clinical study, evaluating the Penumbra System with Thunderbolt Aspiration Tubing for acute ischemic stroke.

Intensity Therapeutics and SAKK Initiate Phase 2 Trial of INT230-6 in Triple-Negative Breast Cancer

11/1/2024

Intensity Therapeutics and SAKK collaborate on INVINCIBLE-4, a Phase 2 trial evaluating INT230-6 plus standard-of-care (SOC) versus SOC alone in localized triple-negative breast cancer (TNBC).

FDA Grants Fast Track Designation to Lipocine's LPCN 1148 for Sarcopenia in Decompensated Cirrhosis

12/18/2024

The FDA has granted Fast Track designation to Lipocine's LPCN 1148 for the treatment of sarcopenia in patients with decompensated cirrhosis.

CanSino Biologics Initiates Phase II/III Trial for Tdcp Adolescent and Adult Vaccine

12/20/2024

CanSino Biologics has commenced a Phase II/III clinical trial for its Tdcp Adolescent and Adult vaccine, targeting individuals aged six years and older.

BioAge Labs Faces Class Action Lawsuit After Azelaprag Trial Halt

1/8/2025

BioAge Labs is facing a class action lawsuit following the discontinuation of its Phase 2 STRIDES trial for azelaprag due to safety concerns.

AbbVie Files Trade Secret Lawsuit Against Genmab Over ADC Technology in Cancer Drug Development

3/23/2025

AbbVie has filed a lawsuit against Genmab and ProfoundBio alleging misappropriation of trade secrets related to disaccharide technology in antibody-drug conjugates, which Genmab categorically refutes.

Genomadix and Mayo Clinic Collaborate on Precision Medicine for Telestroke via Rapid CYP2C19 Genotyping

11/15/2024

Genomadix and Mayo Clinic have entered a know-how license agreement to enhance telestroke services using precision medicine.

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