European Pharmaceutical Review

JANUARY 17, 2024

The small molecule heart failure drug acoramidis has potential in slowing or stopping the progression of transthyretin amyloid cardiomyopathy (ATTR-CM), according to study data published in the New England Journal of Medicine. The drug was also shown to lower cardiac congestion.

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Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

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Pharmaceutical Technology

MAY 26, 2023

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. The new drug application (NDA) included data from the Phase III FRESCO-2 and FRESCO trials conducted in China.

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pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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European Pharmaceutical Review

OCTOBER 25, 2023

Three key medicine regulatory bodies from the UK, US and Canada have collaborated to publish five guiding principles for machine learning-enabled medical devices MLMDs. The aim is to remove the regulatory burden of reassessment following certain changes and updates to a medical device by a manufacturer.

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Medical Food and Drug Administration Manufacturing Safety 88

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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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Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has accepted and granted priority review to Takeda ’s biologics licence application (BLA) for its enzyme replacement therapy, TAK-755, to treat congenital thrombotic thrombocytopenic purpura (cTTP).

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MARCH 1, 2024

Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. physicians the opportunity to treat their patients with this novel device.”

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AUGUST 23, 2023

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Otsuka Medical Devices”) announce the U.S. The overall vote from the committee was favorable that there was sufficient data to support the use of the device in patients with uncontrolled hypertension. About Recor Medical, Inc.

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Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. The SOLOIST-WHF (worsening heart failure) and SCORED trials together assessed around 12,000 patients.

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European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica.

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Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The regulatory approval was based on the data obtained from the placebo-controlled, double-blind PIONEER trial.

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European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.” US sales of Stelara totalled $6.4

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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. It will analyse the safety and efficacy of OCE-205 in adult HRS-AKI patients having cirrhosis with ascites. A lead candidate of the company, OCE-205 is a peptide therapeutic.

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World of DTC Marketing

DECEMBER 2, 2021

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.

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Pharmaceutical Technology

APRIL 17, 2023

US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA).

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European Pharmaceutical Review

MAY 19, 2023

This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus complex (ABC).

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AceLink Therapeutics’ AL01211 to treat Fabry disease. A glucosylceramide synthase (GCS) inhibitor, AL01211 has high potency, increased selectivity and other beneficial drug properties that support once-a-day oral dosing.

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Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. With an estimated enrollment of 182 patients undergoing abdominoplasty, the company will present data comparing its transdermal system with a placebo in Q3 of 2023.

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Legacy MEDSearch

SEPTEMBER 26, 2023

Saluda Medical, Inc. (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced that the U.S. IDE study with 300 patients enrolled. head and extremity and 1.5T

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Pharmaceutical Technology

MAY 4, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. This cohort showed a safety profile identical to that found in older children and adults.

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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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Pharmaceutical Technology

JUNE 6, 2023

American Regent and Daiichi Sankyo have announced that the INJECTAFER (ferric carboxymaltose injection) has received approval from the US Food and Drug Administration (FDA) to treat iron deficiency in adult patients with heart failure. Approximately 2.8

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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). Avidity Biosciences’ AOC 1020 is intended to reduce the DUX4 mRNA and DUX4 protein expression in muscles in these patients.

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European Pharmaceutical Review

NOVEMBER 28, 2022

Fast Track designation (FTD) has been granted for REM-001 therapy to treat unresectable cutaneous metastatic breast cancer (CMBC) by the US Food and Drug Administration (FDA). The drug was evaluated in four Phase II/III clinical trials in patients previously given chemotherapy and/or failed radiation therapy.

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European Pharmaceutical Review

APRIL 19, 2023

“The approval of Omisirge is a significant development in hematopoietic stem cell transplantation” Omisirge ® (omidubicel-onlv), now US Food and Drug Administration (FDA) approved , is the first allogeneic stem cell transplant therapy to be given marketing authorisation based on results from a global, randomised Phase III clinical study.

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Pharmaceutical Technology

MARCH 10, 2023

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura.

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Pharmaceutical Technology

FEBRUARY 22, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Biohaven ’s new anti-myostatin adnectin, taldefgrobep alfa, to treat spinal muscular atrophy (SMA). We are excited about the potential for taldefgrobep alfa to improve the lives of patients and families affected by SMA.”

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European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. Ultimately, the regulatory body hopes the approach will result in more treatment options and improved patient outcomes.

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European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

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Food and Drug Administration FDA Food Medicine 85

Legacy MEDSearch

NOVEMBER 1, 2022

a developer of medical devices to repair fractures in curved bones, announced it has received 510(k) clearance (K222505) from the U.S. Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. CurvaFix, Inc., every year.

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Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). We eagerly anticipate enrolling our first Phase II patients for INB-400 later this year.”

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European Pharmaceutical Review

DECEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Gilead’s Sunlenca (lenacapavir), a capsid inhibitor for adults living with human immunodeficiency virus type 1 (HIV-1), who cannot be successfully treated with other available treatments. As part of the trial, patients were enrolled into one of two study groups.

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European Pharmaceutical Review

JULY 13, 2023

In many European countries physicians can now prescribe medical cannabis for an array of chronic health conditions, including chronic pain, mental health disorders and neurological conditions. 1 In many countries, medical cannabis is only utilised as a therapy when licensed medications have proven ineffective.

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OCTOBER 30, 2023

Medinol today announced United States Food and Drug Administration (FDA) approval for the EluNIR-PERL drug-eluting stent (DES) for the treatment of coronary artery disease. EluNIR-PERL builds upon the proven performance and clinical data of the EluNIR DES system. For more information, see www.medinol.com.

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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. There were 381 Parkinson’s patients enrolled in the trial. and Joan A.

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NOVEMBER 2, 2023

Xēnix Medical, a surgical implant company focused on the development of novel science-based solutions for patients requiring spinal fusion surgery, today announced that it has received 510(k) clearance from the U.S.

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