FDA approves Alzheimer’s drug from Eisai, Biogen in closely watched decision
Bio Pharma Dive
JANUARY 6, 2023
The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression.
Bio Pharma Dive
JANUARY 6, 2023
The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression.
XTalks
MARCH 9, 2023
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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Pharmaceutical Technology
JANUARY 9, 2023
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).
XTalks
FEBRUARY 3, 2023
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.
XTalks
JANUARY 6, 2023
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).
XTalks
JANUARY 4, 2023
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.
Pharmaceutical Technology
MARCH 1, 2023
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.
World of DTC Marketing
AUGUST 27, 2021
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.
Pharmaceutical Technology
FEBRUARY 17, 2023
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.
Pharmaceutical Technology
JULY 11, 2022
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.
Pharma Phorum
JULY 8, 2022
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.
XTalks
FEBRUARY 6, 2023
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).
Pharmaceutical Technology
SEPTEMBER 19, 2022
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.
Bio Pharma Dive
AUGUST 2, 2021
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
XTalks
APRIL 27, 2022
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.
Delveinsight
AUGUST 13, 2021
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?
XTalks
OCTOBER 4, 2022
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.
Pharmaceutical Technology
FEBRUARY 3, 2023
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.
Pharmaceutical Technology
JULY 8, 2022
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
XTalks
JANUARY 13, 2023
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.
Pharma Phorum
JANUARY 23, 2023
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.
XTalks
OCTOBER 4, 2022
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.
Outsourcing Pharma
JANUARY 25, 2022
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.
XTalks
JANUARY 26, 2023
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.
Bio Pharma Dive
JUNE 8, 2021
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
XTalks
JANUARY 9, 2023
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.
Pharmaceutical Technology
MARCH 17, 2023
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.
Pharmaceutical Technology
AUGUST 12, 2022
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%
Pharmaceutical Technology
FEBRUARY 1, 2023
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.
XTalks
SEPTEMBER 14, 2022
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.
XTalks
DECEMBER 27, 2022
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.
Pharmaceutical Technology
AUGUST 8, 2022
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.
XTalks
OCTOBER 18, 2022
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.
XTalks
FEBRUARY 3, 2023
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.
Pharmaceutical Technology
FEBRUARY 13, 2023
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.
XTalks
AUGUST 24, 2022
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).
XTalks
MARCH 10, 2023
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.
XTalks
NOVEMBER 7, 2022
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.
XTalks
JANUARY 25, 2023
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.
XTalks
AUGUST 31, 2022
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.
BioPharma Reporter
MAY 5, 2022
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.
Pharmaceutical Technology
AUGUST 29, 2022
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.
BioTech 365
JULY 7, 2022
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
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