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The US Food and DrugAdministration (FDA) has approved Blujepa ( gepotidacin ) antibiotic for uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients aged 12 years old and over. The post FDA approves first-in-class oral antibiotic appeared first on European Pharmaceutical Review.
According to STAT News “after a double-digit decline in 2021, the sector has fallen another 20% in the new year, erasing billions in value and leading even the most seasoned investors to question whether biotech has further to fall. Meanwhile, the Food and DrugAdministration has delayed several drug approvals, and Sen.
GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Presenting quantitative information increased participants’ gist and verbatim recall of drug efficacy. ” Uh…no.
For the COVID-19 vaccine, the Food and DrugAdministration (FDA) set up rigorous standards for vaccine developers to meet. Rather than have patients fill out the paperwork online and get a specific time for their shot, Florida uses the cattle car mentality, leading to people waiting overnight.
A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and DrugAdministration (FDA). The FDA’s stamp of approval for the Fitbit sensor is a big deal.
The US Food and DrugAdministration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. This status offers the drug developer some incentives, such as market exclusivity for seven years on obtaining FDA approval.
UK-based pharmaceutical giant GSK has announced that the US Food and DrugAdministration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.
The US FoodDrugAdministration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). CMT1A is a progressive neuromuscular autosomal-dominant disease that leads to life-long loss of muscle function, as well as disability.
The US Food and DrugAdministration (FDA) Now, overall, the WLA listing comprises of 36 regulatory authorities from 34 Member States. The post European authorities recognised for leading medicine regulatory oversight appeared first on European Pharmaceutical Review.
In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.
IntelGenx Corp announced that the US Food and DrugAdministration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. The drug constricts blood vessels leading to a reduction in swelling and inflammation of blood vessels associated with migraine.
EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and DrugAdministration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.
The US Food and DrugAdministration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, an adeno-associated virus (AAV)-based gene therapy for Danon disease. “RP-A501 Ultimately, this leads to heart failure and can be fatal for male patients.
The Food and DrugAdministration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.
The US Food and DrugAdministration (FDA) has approved commercial production at Bristol Myers Squibb’s newest cell therapy manufacturing facility in Devens, Massachusetts. The post FDA approves new cell therapy manufacturing plant appeared first on European Pharmaceutical Review.
The US Food and DrugAdministration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). We look forward to working collaboratively with the FDA to bring the first RNA therapy directly targeting DUX4 to patients as quickly as possible.”
The US Food and DrugAdministration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The FDA noted that the monovalent Covid-19 vaccines from Pfizer-BioNTech and Moderna are no longer authorised for use in the US.
Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and DrugAdministration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.
The US Food and DrugAdministration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients. at six months and 24 months, respectively, following infusion.
AGEPHA Pharma has received approval from the US Food and DrugAdministration (FDA) for LODOCO (colchicine, 0.5 We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.” mg tablet) to treat cardiovascular disease.
SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and DrugAdministration (FDA) for geographic atrophy (GA), a leading cause of blindness. The post FDA approves first treatment for geographic atrophy appeared first on European Pharmaceutical Review.
The US Food and DrugAdministration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel; beti-cel), the first cell-based gene therapy for the treatment of adult and paediatric patients with beta-thalassemia who require regular red blood cell transfusions. .
The US-based researchers modelled personalised treatments for each virtual patient, assessing US Food and DrugAdministration-approved aducanumab and donanemab, a therapy currently being evaluated and other potential AD therapies. These are identical to doses used in human trials for FDA approval.
Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.
Food & DrugAdministration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. Often, conservative treatment leads to lengthy hospitalizations, high nursing home admittance, and a high one-year mortality rate. Food & DrugAdministration (FDA).
Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and DrugAdministration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
Tell us about Ocugen’s lead programme, OCU400. In April 2024, Ocugen received US Food and DrugAdministration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation.
the leading provider of convenient, clinical-grade blood collection solutions, announced that the U.S. Food and DrugAdministration (FDA) has cleared its Tasso+ lancet as a Class II medical device. See Full Press Release at the Source: Tasso+ Device Earns FDA 510(k) Class II Medical Device Clearance.
Drug Enforcement Administration (DEA) that cannabis be moved from a Schedule I Controlled Substance to a Schedule III Controlled Substance under the federal Controlled Substances Act. Similarly, major pharmaceutical companies are not likely to up their engagement in cannabis drug development. On August 30, the U.S.
The US Food and DrugAdministration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.
The most common solutions today for pain relief are non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, meaning that standard treatments have not changed for a number of years. This leads to psychological harm becoming a significant factor in chronic pain, alongside the physical symptoms. The potential for a digital solution.
Innovative therapies for rare diseases The acquisition will help to drive the growth of CTI’s lead product, kinase inhibitor VONJO ® (pacritinib) “in treating myeloproliferative disease,” stated Dr Adam Craig, President, Chief Executive Officer and Interim Chief Medical Officer of CTI BioPharma.
The US Food and DrugAdministration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. The FDA’s approval of Ogsiveo is based on results from the Phase III DeFi clinical trial , which were published this year in the New England Journal of Medicine.
The US Food and DrugAdministration (FDA) has granted Orphan Drug Designation to Ocelot Bio’s OCE-205 to treat hepatorenal syndrome. A lead candidate of the company, OCE-205 is a peptide therapeutic. Currently, there exist no therapies approved by the Food and DrugAdministration for treating HRS-AKI.
the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and DrugAdministration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software.
Food and DrugAdministration (FDA). “FDA clearance is a significant milestone towards the commercialization of Polso CONNECT and towards creating a new model in chronic care management,” said ChroniSense Medical CEO, Bridget Ross. “FDA clearance is an important validation of our technology.
Strict guidelines from the Food and DrugAdministration (FDA) and the Federal Trade Commission (FTC) require marketers to ensure transparency and accuracy in all communications. FDA Guidelines and Promotional Review Committees Understanding FDA regulations is critical for all pharma marketing professionals.
PTSD is a potentially chronic condition that disrupts lives and can lead to or exacerbate existing health issues such as depression, anxiety, eating disorders, and suicidal thoughts. Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus.
The US Food and DrugAdministration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. This authorisation of BEQVEZ is based on results from the pivotal Phase III BENEGENE-2 study.
Tyber Medical LLC, the global, leading private-label medical device provider for major orthopedic trauma, extremity, and spine companies, has been awarded a U.S. Food and DrugAdministration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. Press Release by: Tyber Medical. Are you hiring?
In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and DrugAdministration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The FDA’s action plan.
Biogen’s decision A strategic review of the company’s R&D work evaluated the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval, Biogen explained.
Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and DrugAdministration (FDA). How has the autologous T-cell immunotherapy field progressed in recent years? Medical Affairs.
The US Food and DrugAdministration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). This can lead to extremely fragile skin that blisters and tears with minor friction or trauma.
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