Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (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.

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Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.”

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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.

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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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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.

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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.

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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.

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Pharmaceutical Technology

DECEMBER 11, 2022

The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza. The vaccine is intended to prevent two respiratory ailments through a single injection.

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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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pharmaphorum

DECEMBER 6, 2022

Pfizer and BioNTech have announced that they have submitted an Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA) for their Omicron BA.4/BA.5-adapted The post Pfizer, BioNTech submit to FDA for Covid vaccine in under 5s appeared first on.

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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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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.

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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).

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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).

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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?

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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.

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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.

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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.

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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.

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pharmaphorum

NOVEMBER 2, 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.

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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.

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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.

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Legacy MEDSearch

FEBRUARY 13, 2023

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 Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software.

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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.

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Pharma Marketing Network

MARCH 11, 2025

Strict guidelines from the Food and Drug Administration (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.

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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.

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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.

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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?

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Pharmaceutical Technology

AUGUST 12, 2022

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 Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The FDA’s action plan.

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