Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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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

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

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Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). Syfovre is claimed to be the first and only therapy approved for GA.

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Pharmaceutical Technology

MAY 5, 2023

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target goal date.

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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. The research paper comparing the two drug delivery methods was published in The Lancet Neurology.

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Pharma Leaders

MARCH 27, 2023

Iovance Biotherapeutics has completed submission of the Biologics License Application (BLA) for lifileucel to the US Food and Drug Administration (FDA). Iovance has submitted BLA based on positive clinical data from the C-144-01 clinical study in patients with advanced post-anti-PD1 melanoma.

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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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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

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

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Pharmaceutical Technology

OCTOBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The post FDA grants approval for Amylyx’s Relyvrio to treat ALS appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for Pfizer and Myovant Sciences ’ Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) to manage moderate-to-severe pain linked with endometriosis in pre-menopausal women.

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MARCH 27, 2023

Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. The LCD screen on the handle of the device allows the physician to visualize internal patient anatomy in line with instrument insertion. Food and Drug Administration (FDA) 510(k) clearance for its FalloView device.

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Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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Pharmaceutical Technology

NOVEMBER 10, 2022

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Swedish Orphan Biovitrum AB ’s (Sobi) Kineret (anakinra) to treat Covid-19 in adult patients who are hospitalised with pneumonia.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Sanofi has received approval from the US Food and Drug Administration (FDA) for its Altuviiio [Antihemophilic Factor (Recombinant) , Fc-VWF-XTEN Fusion Protein-ehtl], to treat a type of inherited bleeding disorder known as haemophilia A. It is expected to be available commercially in April in the US. median ABR.

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Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS).

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Pharmaceutical Technology

FEBRUARY 9, 2023

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat the retinopathy of prematurity (ROP) in preterm infants. The post US FDA approves Regeneron’s Eylea for retinopathy of prematurity in infants appeared first on Pharmaceutical Technology.

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European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

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European Pharmaceutical Review

AUGUST 14, 2023

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The FDA approval was based on positive results from the multi-centre Phase III MAGNITUDE study.

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NOVEMBER 14, 2022

Food and Drug Administration (FDA). Current and planned use cases for IntraOpVSP are expected to align to the needs of physicians across general, craniofacial and maxillofacial, neuro, orthopedic, plastic, thoracic and vascular surgery disciplines. Food and Drug Administration cleared the software for use in 2022.

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SEPTEMBER 12, 2022

a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. Aerin Medical Inc., offices in California and Texas.

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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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Pharmaceutical Technology

NOVEMBER 3, 2022

The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences ’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.

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JULY 25, 2023

The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared NMR test. Are you hiring?

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MAY 22, 2023

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Orlucent® Skin Fluorescence Imaging System. The designation allows a collaborative and streamlined review pathway with FDA so the Orlucent technology can get to the market faster. Orlucent, Inc.,

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Pharmaceutical Technology

JANUARY 12, 2023

The US Food and Drug Administration (FDA) has approved AstraZeneca and Avillion’s Airsupra (albuterol/budesonide), to treat asthma. The drug is being developed by AstraZeneca and Avillion under a co-development agreement signed in March 2018.

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SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. This action is part of the FDA’s ongoing effort to ensure the safe and effective use of blood lancets in the home and health care settings. Tasso, Inc., For more information, please visit www.tassoinc.com.

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Pharmaceutical Technology

OCTOBER 26, 2022

The US Food and Drug Administration (FDA) has granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson ’s (J&J) Tecvayli (teclistamab-cqyv) to treat relapsed or refractory multiple myeloma in adults. Tecvayli treatment offered an overall response rate (ORR) of 61.8%, with 28.2%

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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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SEPTEMBER 5, 2023

a medical software innovator dedicated to enhancing clinical impact in ablation therapy, announced today that it has received 510(k) clearance from the USA Food and Drug Administration (FDA) for its VisAble.IO Techsomed Ltd., “We are excited to receive 510(k) clearance for our VisAble.IO The BioTrace.IO

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European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today? Prefilled syringes bring a range of benefits.

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pharmaphorum

JANUARY 25, 2023

The 501(c)3 non-profit Tidepool, which seeks to empower the next generation of innovations in diabetes management, has announced that the US Food and Drug Administration (FDA) has cleared Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D) in those six years old and above.

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MARCH 22, 2023

Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan® , the non-invasive liver management technology by Echosens. Measurement interpretation has been expanded to all physicians with appropriate training. Are you hiring?

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JANUARY 3, 2023

Food and Drug Administration for its Respiratory Health point of care test. See Full Press Release at the Source: Visby Medical Receives FDA Emergency Use Authorization for Respiratory Health Test for use in CLIA waived settings. The instrument-free Visby Medical device solves this problem. About Visby Medical.

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NOVEMBER 15, 2022

Food and Drug Administration (FDA) 510(k) clearance for its new NiTy+ One-Shot Staple Fixation System. According to Tyber Medical’s Senior Project Engineer Abe Perryman, physicians have responded favorably to the company’s new staple system. About Tyber Medical LLC. Press Release by: Tyber Medical.

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AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension. Are you hiring?

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