European Pharmaceutical Review

MAY 22, 2024

The US Food and Drug Administration (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.

Medicine 93

Medicine Leads Food and Drug Administration Safety 93

World of DTC Marketing

SEPTEMBER 7, 2022

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.

Pharma 210

Pharma Food and Drug Administration Marketing Prescription 210

Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (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.

Food and Drug Administration 98

Food and Drug Administration FDA Food Marketing 98

Legacy MEDSearch

OCTOBER 25, 2022

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 Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Side effects 98

European Pharmaceutical Review

FEBRUARY 7, 2023

The US Food and Drug Administration (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.

Food and Drug Administration 105

Food and Drug Administration FDA Medicine Food 105

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (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.

Marketing 97

Marketing FDA Food and Drug Administration Pharmaceutical 97

European Pharmaceutical Review

JUNE 11, 2023

The US Food and Drug Administration (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.

Manufacturing 105

Manufacturing Food and Drug Administration FDA Engineering 105

Pharmaceutical Technology

JANUARY 19, 2023

The US Food and Drug Administration (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.”

Food and Drug Administration 98

Food and Drug Administration FDA Food Safety 98

Pharmaceutical Technology

APRIL 19, 2023

The US Food and Drug Administration (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.

FDA 133

FDA Food and Drug Administration Food Leads 133

Pharmaceutical Technology

NOVEMBER 23, 2022

The US Food and Drug Administration (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.

Food and Drug Administration 105

Food and Drug Administration FDA Side effects Food 105

Pharmaceutical Technology

OCTOBER 7, 2022

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 Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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Food and Drug Administration FDA Healthcare Provider Prospecting 119

Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (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.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (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.

FDA 98

FDA Food and Drug Administration Food Leads 98

European Pharmaceutical Review

AUGUST 18, 2022

The US Food and Drug Administration (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. .

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Food and Drug Administration Patients FDA Food 98

European Pharmaceutical Review

NOVEMBER 4, 2022

The US-based researchers modelled personalised treatments for each virtual patient, assessing US Food and Drug Administration-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.

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Food and Drug Administration Side effects Food Patients 105

European Pharmaceutical Review

NOVEMBER 9, 2023

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 and Drug Administration 115

Food and Drug Administration Side effects Pharmaceutical Leads 115

Legacy MEDSearch

NOVEMBER 1, 2022

Food & Drug Administration (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 & Drug Administration (FDA).

Food and Drug Administration 98

Food and Drug Administration FDA Recruitment Food 98

Pharmaceutical Technology

APRIL 4, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Pharmaceutical 98

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

European Pharmaceutical Review

JUNE 13, 2024

Tell us about Ocugen’s lead programme, OCU400. In April 2024, Ocugen received US Food and Drug Administration (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.

Manufacturing 145

Manufacturing Food and Drug Administration Engineering Safety 145

Legacy MEDSearch

SEPTEMBER 16, 2022

the leading provider of convenient, clinical-grade blood collection solutions, announced that the U.S. Food and Drug Administration (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.

Medical 97

Medical FDA Food and Drug Administration Recruitment 97

European Pharmaceutical Review

FEBRUARY 2, 2024

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.

Food and Drug Administration 97

Food and Drug Administration FDA Food Marketing 97

PM360

OCTOBER 25, 2023

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.

Food and Drug Administration 119

Food and Drug Administration FDA Medical Insurance 119

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (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.

Food and Drug Administration 105

Food and Drug Administration Engineering Patients Food 105

European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. The research paper comparing the two drug delivery methods was published in The Lancet Neurology.

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Food and Drug Administration Medicine Physicians Food 98

European Pharmaceutical Review

MAY 12, 2023

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.

Food and Drug Administration 105

Food and Drug Administration Biopharma Medicine Food 105

European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (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.

Food and Drug Administration 104

Food and Drug Administration Medicine FDA Food 104

Pharmaceutical Technology

AUGUST 23, 2022

The US Food and Drug Administration (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 Drug Administration for treating HRS-AKI.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Legacy MEDSearch

DECEMBER 8, 2022

Food and Drug Administration (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.

FDA 97

FDA Patients Food and Drug Administration Medical 97

European Pharmaceutical Review

AUGUST 23, 2022

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.

Food and Drug Administration 94

Food and Drug Administration Pharmacology Prospecting Medical 94

Legacy MEDSearch

NOVEMBER 15, 2022

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 Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. Press Release by: Tyber Medical. Are you hiring?

Medical 98

Medical FDA Food and Drug Administration Engineering 98

European Pharmaceutical Review

APRIL 29, 2024

The US Food and Drug Administration (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.

Food and Drug Administration 96

Food and Drug Administration Medicine FDA Food 96

European Pharmaceutical Review

MAY 23, 2024

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 Drug Administration (FDA). How has the autologous T-cell immunotherapy field progressed in recent years? Medical Affairs.

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Food and Drug Administration Food Medical Medicine 110

European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (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.

Food and Drug Administration 105

Food and Drug Administration Medicine FDA Food 105

European Pharmaceutical Review

JANUARY 23, 2023

There are major concerns about microbial contamination in cannabis, US Food and Drug Administration (FDA) researchers observed in a study. Investigational New Drug (IND) applications for cannabis as therapeutics tested in clinical trials must comply with FDA’s requirements and standards for drug products.

Food and Drug Administration 119

Food and Drug Administration FDA Media Food 119

Legacy MEDSearch

MARCH 13, 2023

Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. and Europe. Are you hiring?

Medical 98

Medical FDA Food and Drug Administration Recruitment 98

Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite. About NeuroLogica. NeuroLogica Corp., Press Release by: NeuroLogica.

FDA 92

FDA Food and Drug Administration Electronics Recruitment 92