Roche gets FDA approval for HER2 breast cancer diagnostic

Pharma Phorum

The FDA has approved Swiss pharmaceutical company Roche’s first companion diagnostic for identifying those patients with HER2 low-metastatic breast cancer who are eligible for ENHERTU. The post Roche gets FDA approval for HER2 breast cancer diagnostic appeared first on.

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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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.

Rigel’s Rezlidhia (olutasidenib) Gets FDA Approval for Relapsed or Refractory AML

XTalks

Rigel Pharmaceuticals’ isocitrate dehydrogenase-1 mutant (mIDH1) targeting small molecule inhibitor Rezlidhia (olutasidenib) has won US Food and Drug Administration (FDA) approval for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML).

ImmunoGen’s Elahere Gets FDA Approval for Platinum-Resistant Ovarian Cancer

XTalks

has won US Food and Drug Administration (FDA) approval for its antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. It is also the first new drug approval in eight years for advanced ovarian cancer.

AstraZeneca’s Immunotherapy Imjudo (tremelimumab) Wins FDA Approval for Liver Cancer

XTalks

The FDA clearance is the first for tremelimumab, which faced an uphill battle after having suffered several failures in trials for other cancer types over the past two decades of its development, including non-small cell lung cancer, head and neck cancer and bladder cancer.

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.

FDA Approves Rebyota as First Fecal Microbiome Therapy for Recurrent C. Difficile Infection

XTalks

Swiss company Ferring Pharmaceuticals has won a historic approval from the US Food and Drug Administration (FDA) for its fecal transplant-based therapy Rebyota (fecal microbiota, live-jslm) to reduce the recurrence of bacterial infection.

Sanofi’s Enzyme Replacement Therapy Xenpozyme Wins FDA Approval for Rare Disease ASMD

XTalks

After approvals in Japan and Europe, Sanofi’s Xenpozyme has secured one from the US Food and Drug Administration (FDA) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.

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.

Bluebird’s $2.8M Gene Therapy Zynteglo Wins Landmark FDA Approval for Beta Thalassemia

XTalks

Bluebird bio’s gene therapy Zynteglo (betibeglogene autotemcel, beti-cel) has been awarded a much anticipated approval from the US Food and Drug Administration (FDA) for the treatment of adult and pediatric patients with beta thalassemia who need regular blood transfusions.

Elucirem (gadopiclenol) is FDA-Approved for Contrast-Enhanced MRI

XTalks

Guerbet, a pharmaceutical company based in France that specializes in medical imaging, obtained US Food and Drug Administration (FDA) approval for Elucirem (gadopiclenol), a new macrocyclic GBCA. XTALKS WEBINAR: Response Prediction in Oncology Clinical Trials.

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

XTalks

Yesterday, Abbott announced that their Proclaim Plus spinal cord stimulation system received approval from the US Food and Drug Administration (FDA). The SUNBURST clinical trial showed that BurstDR stimulation is superior to tonic stimulation for overall pain.

FDA Approves New Immunotherapies for Multiple Myeloma and Liver Cancer – Xtalks Life Science Podcast Ep. 84

XTalks

In this episode, Ayesha discussed the FDA approval of two new immunotherapies, including Janssen/Johnson & Johnson’s bispecific antibody Tecvayli for the treatment of relapsed or refractory multiple myeloma. The drug is the first bispecific T cell antibody to be approved in the US.

US FDA approves Ferring’s Rebyota for Clostridioides difficile infection

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above.

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

FDA Approval of Sanofi’s Enzyme Replacement Drug for ASMD + Disney Actress Partners with Medtronic for Diabetes Tech Campaign – Xtalks Life Science Podcast Ep. 77

XTalks

In this episode, Ayesha discussed the FDA approval of Sanofi’s enzyme replacement therapy Xenpozyme for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD), a rare genetic lysosomal storage disease, in adults and pediatric patients.

Omlonti Granted FDA Approval in Glaucoma and Ocular Hypertension

XTalks

Omlonti was approved by the US FDA for reducing elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. XTALKS WEBINAR: Trials of Tomorrow: The Latest Technologies Advancing Dry Eye Disease Research.

Rinvoq Gets FDA Approval for Treatment of Non-Radiographic Axial Spondyloarthritis

XTalks

Rinvoq received its sixth FDA approval, this time it is for treating adults with non-radiographic axial spondyloarthritis, a form of inflammatory arthritis that affects the spine. Rinvoq Efficacy, Safety and Tolerability Assessed in SELECT-AXIS 2 Clinical Trial.

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure

Pharma Phorum

Eli Lilly and Boehringer Ingelheim’s blockbuster diabetes drug Jardiance (empagliflozin) has been granted approval by the US Food and Drug Administration (FDA) for a wider range of heart failure patients. .

Multiple Myeloma Drug Tecvayli Becomes First FDA-Approved Bispecific T Cell Antibody

XTalks

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Tecvayli (teclistamab-cqyv) for the treatment of relapsed or refractory multiple myeloma.

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

US FDA approves Provention Bio’s Tzield to delay diabetes

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Provention Bio’s biologics licence application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients.

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.

Sotyktu (deucravacitinib) Gets FDA Approval for Moderate-to-Severe Plaque Psoriasis

XTalks

Last week, Bristol Myers Squibb (BMS) announced that their therapy Sotyktu (deucravacitinib) was approved by the US Food and Drug Administration (FDA) as a first-line treatment for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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

Fitbit Introduces New Smartwatch with AFib Detection + FDA Approves Imbruvica for Pediatric Patients with cGVHD – Xtalks Life Science Podcast Ep. 76

XTalks

Ayesha also discussed the FDA approval of Imbruvica (ibrutinib) for pediatric patients one year of age and older with chronic graft-versus-host disease (cGVHD). This is the BTK inhibitor’s first approval for a pediatric indication, and the first approved liquid form of the drug.

Akebia tries for FDA approval of anemia drug after mixed data

Bio Pharma Dive

The drugmaker's pill fell short on a critical safety measure in two large trials last fall. That result, and the surprisingly close FDA scrutiny of a rival medicine from FibroGen, makes the approval prospects of both treatments uncertain

FDA Approves Spesolimab-Sbzo Injection for GPP Flares in adults

The Pharma Data

GPP can be life- hanging and until moment there have been no specific approved curatives for treating the ruinous GPP flares. approved treatment option for those in need. ”. The FDA’s blessing of spesolimab is grounded on results from the vital EFFISAYIL ® 1 Phase II clinical trial.1

CPhI Report forecasts explosion of contract services growth due to surging INDs and 75 FDA approvals by 2025

Pharma Mirror

The report anticipates breakthroughs in multi-modal disease therapies within five years, mRNA platforms to transform many new non-infectious disease treatment options, and huge growth in contract services due to the recent surge in IND applications – with 75 annual FDA approvals expected by 2025.

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.

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.

FDA Approves New Treatment Option for Patients with ALS

The Pharma Data

Food and Drug Administration moment approved Relyvrio( sodium phenylbutyrate/ taurursodiol) to treat cases with amyotrophic side sclerosis( ALS), generally appertained to as Lou Gehrig’s complaint. The FDA remains married to easing the development of fresh ALS treatments. ” TheU.S.

 US FDA Approves Prestige Biopharma’s IND for Phase 1/2a Trial of First-in-Class Pancreatic Cancer Treatment, PBP1510

BioTech 365

ImmunoGen ELAHERE wins accelerated FDA approval for ovarian cancer

Pharma Phorum

has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. Continued approval of ImmunoGen’s first-in-class ADC directed against FR? – ImmunoGen, Inc.

FDA Approves Accelerated Dosing in Non-Hodgkin’s Lymphoma/Leukemia Clinical Trial

BioTech 365

FDA Approves Accelerated Dosing in Non-Hodgkin’s Lymphoma/Leukemia Clinical Trial FDA Approves Accelerated Dosing in Non-Hodgkin’s Lymphoma/Leukemia Clinical Trial AVM Biotechnology eliminates dose cohorts in Non-Hodgkin’s Lymphoma/Leukemia clinical trial with FDA approval.

Neovasc Announces FDA Approval of COSIRA-II Clinical Trial

BioTech 365

Neovasc Announces FDA Approval of COSIRA-II Clinical Trial Neovasc Announces FDA Approval of COSIRA-II Clinical Trial Company on Schedule to Commence Trial Late This Year VANCOUVER and MINNEAPOLIS, Sept. 16, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. Neovasc” or the “Company”) … Continue reading → GlobeNewswire

Janssen’s Simponi Aria Gains Extended FDA Approvals for Rare Children’s Arthritis Conditions

XTalks

The US Food and Drug Administration (FDA) has given approval to Janssen Pharmaceutical for Simponi Aria (golimumab) in the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA). The GO-VIVA Clinical Trial.

Immunocore claims first-ever FDA approval for TCR cancer therapy

Pharma Phorum

Immunocore has secured a piece of biotech industry history, becoming the first company to get an FDA approval for a cancer therapeutic based on T cell receptor (TCR) technology. The post Immunocore claims first-ever FDA approval for TCR cancer therapy appeared first on.

RINVOQ® (Upadacitinib) Receives Its Sixth U.S. FDA Approval

The Pharma Data

RINVOQ is now approved as the first and only oral JAK inhibitor for adults with active non-radiographic axial spondyloarthritis (nr-axSpA) RINVOQ is the first and only JAK inhibitor approved for both active ankylosing spondylitis (AS) and nr-axSpA 1-3 In a clinical study, RINVOQ delivered rapid and meaningful disease control based on patients achieving ASAS40 vs. placebo, as well as significant improvement in signs and symptoms of nr-axSpA at week 14 1,2.

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

HR 82

Krystexxa Chronic Gout Medication Gets Expanded FDA Approval

XTalks

Rare and rheumatic disease-focused biotech Horizon Therapeutics has received expanded approval from the US Food and Drug Administration (FDA) for its gout injection Krystexxa (pegloticase) to include its co-administration with the immunomodulator methotrexate.

Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

Pharma Phorum

Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check. The post Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval appeared first on.