European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

Food and Drug Administration 90

Food and Drug Administration Patients Leads Side effects 90

Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy. ETDRS letters.

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Food and Drug Administration FDA Safety Insurance 52

Pharmaceutical Technology

APRIL 25, 2023

After missing the previous Q1 deadline, bluebird bio has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its sickle cell disease gene therapy lovo-cel, based on an April 24 company announcement.

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Food and Drug Administration Patients Pharmaceutical Food 52

Clarivate

NOVEMBER 13, 2023

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them.

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Patients Food and Drug Administration FDA Safety 52

European Pharmaceutical Review

DECEMBER 28, 2023

We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval. These efficacy results, combined with the safety profile that allows patients to complete their treatment regimen, are extremely encouraging.

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Food and Drug Administration Patients Safety Medical science 84

Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. I’m excited that the study met its superiority composite endpoint, which included effectiveness and safety components. and projected to impact 70 million Americans by 2040.

Marketing 96

Marketing FDA Food and Drug Administration Specialization 96

Legacy MEDSearch

JULY 11, 2022

based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. Significant adverse events include corneal edema, vision-impairing corneal edema, corneal transplant, and decrease in visual acuity.

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Food and Drug Administration Recruitment FDA Patients 52

European Pharmaceutical Review

JULY 13, 2023

A new therapeutic antibody class, bispecific antibodies, was engineered to build on the classic antibody design and bind to two different proteins, demonstrating how incremental changes in protein design can lead to entirely new therapies. 3 The CARs recognise and bind to proteins on the surface of cancer cells, effectively killing them.

Engineering 84

Engineering Food and Drug Administration Safety Patients 84

pharmaphorum

JANUARY 30, 2023

One of the reasons is the most evident: the winter months often lead to greater need for antibiotics, and that can lead to shortages. For its part, the US Food and Drug Administration (FDA) posted its drug shortage list , which contains various formulations of amoxicillin that are limited in supply.

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Food and Drug Administration Medicine Manufacturing Pharmaceutical 80

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. No serious adverse events were reported.

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Food and Drug Administration Manufacturing Safety Pharmaceutical 85

Evolve Your Success

MAY 17, 2022

You know when they are trying to push a drug and white-knuckling it. You ask the hospital administrators to figure out the financial aspects of that side of it. What drugs are we using? This office or rep prescribed this drug and this is what I want you to know about this drug.”. You do not even have to say it.

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Medical sales Medical Sales Patients 52

European Pharmaceutical Review

DECEMBER 16, 2022

In a clinical setting, etranacogene dezaparvovec continued to be generally well-tolerated with no serious treatment-related adverse events (SAEs). The gene therapy was recently approved by the US Food and Drug Administration (FDA). IU/yr/participant (from lead-in period to months 13-18).

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Food and Drug Administration Safety Patients Leads 80

Impetus Digital

NOVEMBER 14, 2022

We know from real-world evidence that drug efficacy and safety can differ based on age, sex, race, and ethnicity; these discrepancies may jeopardize treatment outcomes in undertested groups. Despite accounting for more than 40% of the US population, ethnic minority groups reportedly only account for 5–10% of clinical trial populations.

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Pharma Recruitment Food and Drug Administration Patients 92

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. SerpinPC causes the inhibition of coagulation factor XIV, which leads to an increase in thrombin production, speeding up the clot formation process.

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FDA Food and Drug Administration Prospecting Food 59

Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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Food and Drug Administration Pharmaceutical Food Side effects 98