MedPath

Tailored TKI Dosing Strategies Improve Outcomes in Chronic Myeloid Leukemia

10/10/2024

Tailored dosing of tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia (CML) improves safety without compromising efficacy, according to Elias Jabbour, MD.

FDA Approves Neffy, Needle-Free Epinephrine Nasal Spray Developed by ARS Pharmaceuticals

10/10/2024

ARS Pharmaceuticals' Neffy, an epinephrine nasal spray, has received FDA approval, offering a needle-free alternative to EpiPens for allergic reactions.

Ramucirumab Plus Osimertinib Extends PFS in EGFR-Mutated NSCLC

10/10/2024

The RAMOSE trial demonstrated that adding ramucirumab to osimertinib significantly prolonged progression-free survival (PFS) in patients with EGFR-mutated non-small cell lung cancer (NSCLC).

FDA Approves Subcutaneous Ocrevus Zunovo for Multiple Sclerosis

9/16/2024

The FDA has approved Ocrevus Zunovo, a subcutaneous formulation of ocrelizumab, for all forms of multiple sclerosis, including relapsing MS and primary progressive MS.

LILAC-TIMI 76 Trial Evaluates Factor XI Inhibitor for Atrial Fibrillation Patients

10/10/2024

The LILAC-TIMI 76 trial is assessing a novel Factor XI inhibitor as a monthly medication for atrial fibrillation patients at increased risk of stroke.

Intensive Blood Pressure Lowering Linked to Improved Stroke-Free Survival in High-Risk Patients

9/16/2024

A pooled analysis of SPRINT and ACCORD-BP trials reveals that intensive blood pressure control (target <120 mmHg) is associated with improved stroke-free survival.

Aquestive's Sublingual Epinephrine Film, Anaphylm, Nears NDA Submission for Anaphylaxis Treatment

10/11/2024

Aquestive Therapeutics anticipates submitting a New Drug Application (NDA) for Anaphylm, a sublingual epinephrine film, to the FDA in the first quarter of 2025.

FDA Approves Pfizer's Hympavzi for Hemophilia A and B

10/11/2024

The FDA has approved Hympavzi (marstacimab-hncq), a once-weekly subcutaneous injection, for hemophilia A and B to prevent or reduce bleeding episodes.

Medtronic's Affera System Receives FDA Approval for Ventricular Tachycardia Treatment Study

10/12/2024

Medtronic gains FDA approval for an early feasibility study of the Affera Mapping and Ablation System with Sphere-9 Catheter for sustained ventricular tachycardia (VT).

Ibrutinib/Venetoclax Shows Survival Benefit in High-Risk CLL/SLL

10/12/2024

Fixed-duration ibrutinib plus venetoclax demonstrates meaningful survival benefits in high-risk CLL/SLL patients, with 5-year OS rates of 90% or greater.

Pembrolizumab Plus Chemoradiotherapy Significantly Improves Survival in High-Risk Cervical Cancer

11/5/2024

The KEYNOTE-A18 trial demonstrated a significant overall survival (OS) benefit with pembrolizumab plus chemoradiotherapy in high-risk, locally advanced cervical cancer patients.

Cipher Pharmaceuticals Faces Temporary Setback with Nail Fungus Treatment Data

9/16/2024

Cipher Pharmaceuticals' partner, Moberg Pharma, reported weaker-than-expected clinical cure data from a North American Phase 3 study of MOB-015 for nail fungus.

INmune Bio Announces $12 Million Offering to Advance Clinical Programs

9/16/2024

INmune Bio is offering 2,341,260 shares of common stock along with warrants to raise approximately $12 million for clinical trials and corporate purposes.

FDA Approves Apple Watch Feature for Sleep Apnea Detection

9/16/2024

The FDA has approved Apple's Sleep Apnea Notification Feature (SANF) for the Apple Watch, enabling over-the-counter risk assessment of sleep apnea.

Quanta Dialysis System Receives FDA Clearance for Home Hemodialysis

11/5/2024

Quanta Dialysis Technologies' Quanta Dialysis System has received FDA 510(k) clearance for home hemodialysis, expanding access to high dialysate flow treatment.

Native Hawaiians and Pacific Islanders Underrepresented in Key Clinical Trials

11/5/2024

A recent study reveals significant underrepresentation of Native Hawaiians and Pacific Islanders in clinical trials for top-selling drugs, impacting access to innovative therapies.

Lundbeck to Acquire Longboard Pharmaceuticals for $2.6 Billion, Bolstering Epilepsy Pipeline

10/14/2024

Lundbeck will acquire Longboard Pharmaceuticals for $2.6 billion, gaining bexicaserin, a promising drug for developmental and epileptic encephalopathies (DEEs).

Johnson & Johnson's Q3 Earnings Preview: MedTech Expansion and Trial Setbacks

10/14/2024

Johnson & Johnson is set to release its Q3 earnings, with Wall Street anticipating an EPS of $2.21 and revenue of $22.16 billion.

FDA Approves Journey Medical's Emrosi for Rosacea Treatment

11/5/2024

The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride extended-release capsules) for treating rosacea, a chronic inflammatory skin condition.

FDA to Reassess Tirzepatide Shortage Status Amidst Compounding Dispute

10/14/2024

The FDA will re-evaluate the shortage status of tirzepatide, the active ingredient in Zepbound and Mounjaro, following a lawsuit from compounding pharmacies.

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