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

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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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.

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

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 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.

Flash FDA approval sends ChemoCentryx spiralling upwards

Pharma Phorum

ChemoCentryx has claimed FDA approval for its avacopan drug for a rare autoimmune disease, becoming the first orally-active drug that targets the complement C5 receptor. The post Flash FDA approval sends ChemoCentryx spiralling upwards appeared first on.

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.

Breakthrough Cervical Cancer Treatment Wins Accelerated FDA Approval

BioSpace

It earned the FDA's green light after its Phase II innovaTV 204 clinical trial delivered stellar results in terms of tumor response and durability of the response

Pfizer, BioNTech file for FDA approval of COVID booster shot

Pharma Phorum

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The post Pfizer, BioNTech file for FDA approval of COVID booster shot appeared first on.

GSK’s Dostarlimab Wins FDA Approval for dMMR Endometrial Cancer

XTalks

GSK’s immunotherapy dostarlimab-gxly (Jemperli) has been granted accelerated approval by the US Food and Drug Administration (FDA) for the treatment of recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer. Dostarlimab and the GARNET Trial.

Roche receives FDA approval for first companion diagnostic to identify.

The Pharma Data

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company’s commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies.

Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval

Pharma Phorum

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity.

Failed trial nixes another FDA approval, this time for BMS’ Istodax

Pharma Phorum

Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. News Oncology Bristol-Myers Squibb fda Istodax lymphoma

Merck’s Next-Generation Pneumonia Vaccine Gets FDA Approval

XTalks

Merck has scored US Food and Drug Administration (FDA) approval for its next-generation pneumonia vaccine Vaxneuvance that covers 15 different strains of the pneumococcal bacteria that causes the infection.

Janssen Announces U.S. FDA Approval of INVEGA HAFYERA™ (6-month paliperidone.

The Pharma Data

Approval is backed by nearly two decades of proven efficacy and safety of Janssen’s long-acting injectable portfolio of schizophrenia medicines. DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator. About the Clinical Trial.

FDA Approvals Roundup: Kloxxado, Farxiga, Ferriprox

The Pharma Data

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). . New approvals. Hikma’s Kloxxado (naloxone hydrochloride nasal spray) has been approved for treating opioid overdose.

BMS Flying High in May With Opdivo, Zeposia FDA Approvals

BioSpace

Bristol Myers Squibb has been busy the last two weeks with a string of approvals, positive clinical trial updates and deals. Here’s a look

C-Path PRO Consortium measure used to support an FDA-approved label claim

Scienmag

Diary for Irritable Bowel Syndrome Symptoms-constipation is the first patient-reported outcome consortium measure used to support an FDA-approved label claim TUCSON, Ariz., Medicine & Health Clinical Trials Gastroenterology Medicine/Health

Mission successful for Novartis after FDA approves ofatumumab in MS

Pharma Phorum

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

Amgen’s Sotorasib Wins FDA Approval for Previously ‘Undruggable’ KRAS Mutant NSCLC

XTalks

The US Food and Drug Administration (FDA) has granted approval to Amgen’s KRAS inhibitor Lumakras (sotorasib) as the first treatment for non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation.

Medidata synthetic control arm lands FDA approval for cancer trial

Outsourcing Pharma

The control arm, engineered from historical trial data derived from more than 22,000 previous studies, will be used in a Phase III cancer trial.

FDA approves BMS’ multiple myeloma CAR-T Abecma

Pharma Phorum

The FDA has approved Bristol-Myers Squibb’s Abecma (idecabtagene vicleucel) for multiple myeloma, the first cell therapy to treat the disease. The delay was caused by coronavirus restrictions delaying the site inspections necessary for approval.

SU2C research leads to FDA approval of new first-line treatment for colorectal cancer

Scienmag

This is the 9th FDA drug approval supported by Stand Up To Cancer research. This is the 9th FDA approval supported by Stand […].

FDA approves Phase 1 trial for HIV gene therapy

The Pharma Data

The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy. The Phase 1 trial is expected to be conducted at sites in Baltimore, Maryland and Washington, DC. Air Force photo by Kemberly Groue.

Impulse Dynamics Announces FDA Approval for Magnetic Resonance Imaging

The Pharma Data

“It’s important that Impulse Dynamics acted quickly in a joint effort with the FDA to remove this potential barrier standing in the way of critical diagnostic procedures for a subset of patients with HF.

F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

NY Times

Alzheimer's Disease Drugs (Pharmaceuticals) Food and Drug Administration Clinical Trials Biogen IncAducanumab is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process.

F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

NY Times

Alzheimer's Disease Drugs (Pharmaceuticals) Food and Drug Administration Clinical Trials Biogen IncAducanumab, or Aduhelm, is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process.

FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

Food and Drug Administration (FDA) has approved an updated label for ADUHELM (aducanumab-avwa) injection 100 mg/mL solution. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM.

FDA approves AZ’s anifromulab, ending 10-year lupus drug drought

Pharma Phorum

AstraZeneca has completed the resurrection of its anifrolumab drug for systemic lupus erythematosus (SLE) after claiming FDA approval for the drug as an add-on therapy for adults with the autoimmune disease.

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer

The Pharma Data

FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Professional.

J&J files lung cancer bispecific amivantamab for FDA approval

Pharma Phorum

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). The post J&J files lung cancer bispecific amivantamab for FDA approval appeared first on.

FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. 10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

FDA approves Bayer/Merck & Co heart failure drug

Pharma Phorum

Bayer and Merck & Co’s heart failure drug vericiguat has been approved by the FDA under the brand name Verquvo, in an increasingly competitive market. Entresto (sacubitril+valsartan) was FDA-approved in patients with reduced ejection fraction five years ago.

Hanmi Pharmaceutical expects U.S. FDA approval for 2 new drugs

The Pharma Data

are expected to be approved by the U.S. FDA this year. as a treatment for metastatic breast cancer, under priority review by FDA are about to announce the results of their BLA/NDA approval (biologics license application; BLA), respectively. FDA approval this year.

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma

The Pharma Data

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. Food and Drug Administration (“FDA”) has approved Danyelza (naxitamab-gqgk) 40mg/10ml. The FDA granted approval under the accelerated approval regulation.

U.S. FDA APPROVES TICOVAC™, PFIZER’S TICK-BORNE ENCEPHALITIS (TBE) VACCINE

The Pharma Data

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S.

Lower-Profile Web Intrasaccular Aneurysm Treatment Device Receives FDA Approval

The Pharma Data

based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. .

Janssen’s depression nasal spray Spravato bags new FDA approval

The Pharma Data

Drug approved to treat major depressive disorder with acute suicidal ideation or behaviour.

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19

The Pharma Data

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. About the ACTT-1 Trial.

Genetech scores sixth FDA approval in lung cancer with Gavreto

The Pharma Data

Genentech’s once-daily oral therapy Gavreto (pralsetinib) has secured FDA backing in the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), it has emerged.

FDA approves Nexviazyme® (avalglucosidase alfa-ngpt), an important new treatment option for late-onset Pompe disease

The Pharma Data

Approval is based on positive Phase 3 data demonstrating improvements in key disease burden measures and establishing its safety profile Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells.

New Day For Diabetes Patients As FDA Approves First-Ever Interchangeable Biosimilar

BioSpace

Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies