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FDA approves Alzheimer’s drug from Eisai, Biogen in closely watched decision

Bio Pharma Dive

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression.

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Filspari (Sparsentan) Rare Kidney Disease Drug Gets FDA Approval

XTalks

Travere Therapeutics recently announced that their medication Filspari (sparsentan) received accelerated approval from the US Food and Drug Administration (FDA). Filspari is the first single molecule dual endothelin angiotensin receptor antagonist (DEARA) approved for this indication.

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US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

Pharmaceutical Technology

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD).

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Jaypirca (pirtobrutinib) Is Now FDA Approved to Treat Relapsed or Refractory Mantle Cell Lymphoma

XTalks

The decision was based on the results from a Phase I/II study, and continued approval is dependent upon the results of a confirmatory Phase III trial. Different types of TKIs have been approved to treat multiple cancers, including blood cancers.

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Briumvi is FDA Approved for Relapsing Forms of Multiple Sclerosis

XTalks

Last week, the FDA approved a new infusible medication from TG Therapeutics for adults with relapsing forms of multiple sclerosis (MS), which include clinically isolated syndrome (CIS), relapsing-remitting (RR) MS, and active secondary progressive MS (SPMS).

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MediWound’s NexoBrid is FDA Approved for the Treatment of Severe Thermal Burns

XTalks

NexoBrid was already approved for use in 43 countries, including the European Union, India, Japan and others. This US FDA approval of NexoBrid validates our enzymatic technology platform. million milestone payment from Vericel due to the recent FDA approval of NexoBrid.

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US FDA approves Regeneron-Sanofi’s Kevzara to treat polymyalgia rheumatica

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals and Sanofi ’s Kevzara (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients.

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Clinical trial DTC? It may not be right for your drug candidate

World of DTC Marketing

SUMMARY: Over half of all clinical trial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinical trial enrollment it really depends on the condition and risk as judged by the patient.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.

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US FDA approves Pfizer-BioNTech’s Covid-19 vaccine for adolescents

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Pfizer and BioNTech’s supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for adolescents aged 12 to 15 years.

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Digital tools driving innovative clinical trials

Pharma Phorum

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use.

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Jesduvroq (daprodustat) is FDA Approved for Anemia due to Chronic Kidney Disease

XTalks

GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD).

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FDA approves bluebird bio’s Skysona to treat cerebral adrenoleukodystrophy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients.

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AstraZeneca wins first FDA approval for systemic lupus drug in a decade

Bio Pharma Dive

The regulator cleared Saphnelo despite mixed clinical trial data, giving patients another option after the recent OK for a drug aimed at the autoimmune disease's severe side effects

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Veklury Becomes the First FDA-Approved COVID-19 Treatment for Children Under 12

XTalks

Gilead’s Veklury (remdesivir) gets FDA approval to treat young children with COVID-19 and becomes the first and only approved COVID-19 treatment for children under 12. This is the only approved COVID-19 treatment for children under 12 years of age.

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Reimagining Clinical Trials: Why are Virtual Clinical Trials Becoming the New Normal?

Delveinsight

Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. What are Virtual Clinical Trials?

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Terlivaz (terlipressin) Injection Gets FDA Approval to Treat Hepatorenal Syndrome

XTalks

Recently, Mallinckrodt announced that Terlivaz (terlipressin) has been approved by the US Food and Drug Administration (FDA) to treat adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function. Outcomes of Clinical Trials of Terlipressin.

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US FDA approves Amgen-AstraZeneca’s Tezspire for asthma treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca ’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above.

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Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients. The trial demonstrated that after a median follow-up of 5.2

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Lung Disease Diagnostic Xenoview Gets FDA Approval for Use with MRI

XTalks

Medical imaging tech company Polarean Imaging has recently announced that the US Food and Drug Administration (FDA) has approved their drug-device combination product Xenoview (xenon Xe 129 hyerpolarized). Two More Devices Approved by the FDA Alongside Xenoview.

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BeiGene’s Brukinsa FDA approved for CLL/SLL

Pharma Phorum

Beijing-based pharma, BeiGene’s Brukinsa (zanubrutinib) has been approved by the US Food and Drug Administration (FDA) for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The post BeiGene’s Brukinsa FDA approved for CLL/SLL appeared first on.

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Rolvedon Receives FDA Approval to Prevent Chemotherapy-Related Infections

XTalks

The US Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ Rolvedon (eflapegrastim-xnst) injection. This approval is a significant milestone for our development team and collaboration with Hanmi Pharmaceutical. Clinical Trials and Commercialization.

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FDA approves IND for clinical trial evaluating CBD-based drug

Outsourcing Pharma

Clinical DevelopmentThe agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.

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Brukinsa (zanubrutinib) Gets FDA Approval for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

XTalks

The US Food and Drug Administration (FDA) recently granted approval for the Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) based on the results from two Phase III clinical trials.

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The FDA approved Biogen's Alzheimer's drug. The company now has years to confirm it works.

Bio Pharma Dive

Two near identical clinical trials of Aduhelm yielded conflicting results, dividing experts and even FDA staff. A third, confirmatory study is required, but Biogen has until 2029 to finish it

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Sunlenca (lenacapavir) Receives FDA Approval as HIV Treatment Option for Multi-Drug Resistant Infection

XTalks

recently announced in a press release that Sunlenca (lenacapavir) received approval from the US Food and Drug Administration (FDA) for use as a twice-yearly treatment option for people living with multi-drug resistant HIV (human immunodeficiency virus). Gilead Sciences, Inc.

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US FDA approves Novartis’ Tafinlar and Mekinist combination therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Novartis ’ combination therapy, Tafinlar (dabrafenib) and Mekinist (trametinib), to treat BRAF V600E low-grade glioma (LGG) in paediatric patients as young as one year.

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US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. In the trial, 1.9%

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US FDA approves Ellipses Pharma’s IND for AML therapy 

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Ellipses Pharma’s investigational new drug (IND) application for EP0042 to treat acute myeloid leukaemia (AML). The post US FDA approves Ellipses Pharma’s IND for AML therapy appeared first on Pharmaceutical Technology.

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Daxxify, a New Anti-Wrinkle Drug and Botox Competitor is FDA-Approved

XTalks

Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. The product has been approved for use in adult patients for the temporary improvement of moderate to severe glabellar (frown) lines.

Botox 98
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FDA Approves Gene Therapy Adstiladrin for the Treatment of Bladder Cancer

XTalks

Boorjian, MD, Carl Rosen Professor and Chair of the Department of Urology at Mayo Clinic, and lead investigator on the recent clinical trial of Adstiladrin, in the company’s press release. The Clinical Trial that Led to the Approval.

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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer.

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Nevro’s AI-Based Spinal Cord Stimulation Device for Chronic Pain Receives FDA Approval

XTalks

Global medical device company Nevro Corp has received US Food and Drug Administration (FDA) approval for the Senza HFX iQ spinal cord stimulation (SCS) system for the treatment of long-term or chronic pain. It is also pursuing a CE mark approval of the spinal cord stimulator in Europe.

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Orserdu (elacestrant) Approved for Patients with ESR1 mutations in ER+/HER2- Advanced or Metastatic Breast Cancers

XTalks

The US Food and Drug Administration (FDA) has approved the first and only oral drug for the treatment of advanced or metastatic breast cancer in postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) ESR1 mutations.

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Pfizer’s sNDA for Cibinqo receives FDA approval for atopic dermatitis

Pharmaceutical Technology

Pfizer has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) to treat a type of atopic dermatitis (AD). Previously, it was approved to treat AD in adults aged 18 years and above.

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Abbott’s Proclaim Plus Spinal Cord Stimulation System Clenches FDA Approval

XTalks

The first clinical use of spinal cord stimulation was in 1967 for chronic pain management in cancer patients. Yesterday, Abbott announced that their Proclaim Plus spinal cord stimulation system received approval from the US Food and Drug Administration (FDA).

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Skyclarys (Omaveloxolone) Becomes the First FDA-Approved Treatment for Friedreich’s Ataxia

XTalks

This US Food and Drug Administration (FDA)-approved drug was also awarded a rare pediatric disease priority review voucher. Skyclarys was approved based on the results of the MOXIe Part 2 clinical trial.

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The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. Regulatory Approvals for CTC-Based Assays in Oncology.

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New Type 2 Diabetes Drug Brenzavvy Wins FDA Approval

XTalks

Massachusetts-based TheracosBio has received US Food and Drug Administration (FDA) approval for diabetes med Brenzavvy (bexagliflozin) to help improve glycemic control in adults with type 2 diabetes. It is the first FDA-approved SGLT2 inhibitor for any animal species.

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FDA Approval of First Rapid-Acting Oral Depression Drug + Approval of $2.8 Million Gene Therapy for Rare Blood Disorder – Xtalks Life Science Podcast Ep. 75

XTalks

In this episode, Ayesha discussed the FDA approval of Axsome Therapeutics’ rapid-acting oral treatment Auvelity for the treatment of major depressive disorder (MDD). Read the full articles here: Axsome’s Auvelity Wins FDA Approval as First Rapid-Acting Oral Treatment for Depression.

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Oramed hits oral insulin clinical trial milestone

BioPharma Reporter

Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the worldâs first Phase 3 study of oral insulin under FDA approved protocols.

Insulin 128
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FDA approves Incyte’s Pemazyre for treating myeloid/lymphoid neoplasms

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Incyte ’s Pemazyre (pemigatinib) to treat adults with relapsed or refractory (r/r) myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.

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Filament Health Announces First Dosing in Groundbreaking FDA-Approved Psilocin Clinical Trial

BioTech 365

Filament Health Announces First Dosing in Groundbreaking FDA-Approved Psilocin Clinical Trial Filament Health Announces First Dosing in Groundbreaking FDA-Approved Psilocin Clinical Trial ??The