The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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The Pharma Data

SEPTEMBER 1, 2021

Approval is backed by nearly two decades of proven efficacy and safety of Janssen’s long-acting injectable portfolio of schizophrenia medicines. The approval of INVEGA HAFYERA™ builds on our 60-year legacy of delivering transformational medicines for adults living with schizophrenia,” said Mathai Mammen, M.D., INDICATION.

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XTalks

MAY 26, 2023

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB). Krystal expects Vyjuvek to be available by the third quarter of this year.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial. Related Articles: Verquvo (vericiguat) FDA Approval History.

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Eye on FDA

APRIL 15, 2020

As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the regulatory process for approving new ones. Drugs coming to market are important in several respects.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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Scienmag

NOVEMBER 8, 2020

Rutgers study also finds doctors continue to prescribe antipsychotic medications without the recommended psychiatric consultation for non FDA-approved conditions The use of antipsychotics in young children is declining but doctors continue to prescribe these medications off-label for conditions not approved by the Food and Drug Administration and without (..)

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. Orgovyx (relugolix) FDA Approval History.

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The Pharma Data

DECEMBER 4, 2021

is a topical prescription medicine used to treat acne vulgaris. Continuing to advance and launch much-needed generic drugs is critical to ensuring access to quality medicines to everyone who needs them.” Talk to your doctor if you are pregnant or plan to become pregnant. 2.5%), in the United States.

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The Pharma Data

APRIL 1, 2021

” Recently, the European Commission (EC) approved RINVOQ (15 mg) for use in adults with active psoriatic arthritis. . * Comparison to adalimumab for these endpoints was not multiplicity-controlled. RINVOQ is a medicine that can lower the ability of your immune system to fight infections. Rifampicin or phenytoin.

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XTalks

AUGUST 21, 2023

The FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Ipsen that can be used for subsequent drug applications that would not qualify for a priority review. The FDA approval of Sohonos is a breakthrough for the US FOP community,” said Howard Mayer, head of R&D at Ipsen, in the company’s news release.

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Pharmaceutical Technology

JULY 28, 2022

Roche’s Susvimo (ranibizumab sustained release formulation) follows a similar theme; patients who are implanted with Susvimo are expected to visit their doctor only twice a year to have the implant refilled so that the medicine can be delivered to their eyes continuously. The therapy received FDA approval in October last year.

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The Pharma Data

MARCH 9, 2021

Continuing to pursue much-needed generic drugs is critical to ensuring access to quality medicines to everyone who needs them.”. Brinzolamide ophthalmic suspension 1% is a prescription medicine used to treat elevated pressure within the eye in people with ocular hypertension or open-angle glaucoma. IMPORTANT SAFETY INFORMATION.

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Pharmacy Checkers

JANUARY 10, 2020

This post is mostly a story about a very well manufactured, safe and effective, foreign version of an FDA-approved drug. These drugs are normally far less expensive than the FDA-approved version sold in the U.S. John’s doctor was skeptical of drugs bought online from other countries. and arguably just as safe.

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pharmaphorum

OCTOBER 12, 2018

The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label. We’ll be looking at how digital and traditional approaches to medicine are being combined to improve patient outcomes.

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Pfizer

SEPTEMBER 27, 2022

Biosimilars are FDA approved, and often offer a lower-cost alternative to biologic therapies that treat challenging diseases like cancer, diabetes, and rheumatoid arthritis. Price controls would base the price of medicines sold in the U.S. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted

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XTalks

JUNE 30, 2023

It’s been a big week for cell and gene therapy approvals in the US, including a much-awaited approval for one to treat hemophilia A, the most common form of hemophilia. The approval came after a couple of setbacks, including a rejection in 2020 and a delay earlier this year.

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Pharmaceutical Technology

AUGUST 12, 2022

We have patients calling us saying, ‘I want to get into this site, but they say [it will be] three months before they can see me,’ and it's not because the doctors don't want to do it. Thus, FDA funding could be what is needed on this front, says Cudkowicz. How far does the FDA’s plan go? They don't have the time for it.”

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STAT News

MARCH 6, 2023

Still, when doctors told her last year that the cancer was growing despite two operations, radiation therapy, and a fifth regimen of chemotherapy, the retired business-meeting facilitator decided to do something unorthodox: spend $83,000 out of pocket on an unproven experimental cancer vaccine.

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Triage Cancer

AUGUST 18, 2020

If you are interested in getting access to a treatment option through the FDA’s Expanded Access program, your chances of success are high! To apply for treatment under the Right to Try Act: The patient speaks to their physician, who will contact the manufacturer of an investigational treatment in an FDA-approved Phase 2 or 3 trial.

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The Pharma Data

JUNE 18, 2021

BOTOX ® Cosmetic is the first and only product of its kind FDA-approved to treat three areas, temporarily improving the appearance of moderate to severe forehead lines, glabellar lines and crow’s feet in adults. Using BOTOX ® Cosmetic with certain other medicines may cause serious side effects. APPROVED USES.

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The Pharma Data

MARCH 7, 2022

Teva’s Lenalidomide capsules are a prescription medicine used in adults for the treatment of (1) multiple myeloma in combination with the medicine dexamethasone, (2) certain myelodysplastic syndromes, and (3) mantle cell lymphoma following specific prior treatment. Call your doctor for medical advice about side effects.

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XTalks

FEBRUARY 16, 2023

However, the company last aired the ad on May 2, 2022, the same day they announced the US Food and Drug Administration (FDA) approval of Quviviq. Quviviq is an FDA-approved prescription medicine that helps treat insomnia in adults, with a low risk of dependence and side effects. estimating Indorsia spent $6.2

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XTalks

MAY 17, 2024

The therapy is the first and only US Food and Drug Administration (FDA)-approved treatment that reduces the loss of kidney function in adults with the disease. He also traced his personal journey from the clinic to leading a rare disease biotech and winning FDA approval for a rare disease drug.

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pharmaphorum

AUGUST 8, 2022

Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ($3.1 billion) blockbuster.

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Drug Discovery World

OCTOBER 18, 2023

in Cell Biology and Biochemistry from University College London and was a post-doctoral fellow at Albert Einstein College of Medicine in New York City. Food & Drug Administration (2017) FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss. She received a Ph.D. References 1: U.S.

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FDA Law Blog

FEBRUARY 21, 2022

Unger, who is a 1971 recipient of the Rensselaer Polytechnic Institute Mathematics and Science Medal, earned a Bachelor of Science (magna cum laude) in chemistry from Wright State University in Dayton, Ohio, and a Doctor of Medicine from the University of Cincinnati College of Medicine in Cincinnati, Ohio.

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Pharmaceutical Technology

FEBRUARY 3, 2023

It was initially FDA-approved in December 2021 and is claimed to be the only biologic approved to treat severe asthma with no phenotype or biomarker limitation. The antibody has already been approved for the same indication in Japan, the EU, the US and other countries.

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The Pharma Data

JANUARY 15, 2021

13 in the New England Journal of Medicine , involved patients with high blood pressure in the lungs caused by interstitial lung disease (ILD). Food and Drug Administration to approve Tyvaso for ILD patients. FRIDAY, Jan. The study, published online Jan. The main side effects were cough and throat irritation from using the inhaler.

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The Pharma Data

MARCH 30, 2021

BOTOX® Indication BOTOX® is a prescription medicine that is injected into muscles and used: To prevent headaches in adults with Chronic Migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older. Using BOTOX® with certain other medicines may cause serious side effects.

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XTalks

DECEMBER 20, 2023

And this year Eli Lilly stepped into the obesity drug market with its own GLP-1 weight loss drug Zepbound (tirzepatide), which the US Food and Drug Administration (FDA) approved in November of this year. Check out this article to learn about the biotech companies that went public this year.

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The Pharma Data

SEPTEMBER 10, 2021

About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken.

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The Pharma Data

JANUARY 20, 2021

The data were presented as a late-breaking abstract at the 2019 European Respiratory Society’s annual meeting and simultaneously published in The Lancet Respiratory Medicine. In 2020, the FDA granted Orphan Drug Designation and Breakthrough Therapy Designation to Esbriet for UILD. About Unclassifiable Interstitial Lung Disease.

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pharmaphorum

DECEMBER 22, 2022

Historically, digital therapeutics (DTx) companies have directed about 95% of their effort into gaining FDA approval and 5% into market access strategy. In 2023, this will shift to a 60%/40% split, with DTx companies having an earlier focus on the commercialisation process, while simultaneously working toward earning FDA approval.

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XTalks

MARCH 16, 2022

A study published in 2003 in Archives of Internal Medicine also wrote about the phenomenon, suggesting that Couric may have inspired many people to get tested for colon cancer, saying “Katie Couric’s televised colon cancer awareness campaign was temporarily associated with an increase in colonoscopy use in two different data sets.

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Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children.

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The Pharma Data

AUGUST 17, 2021

If your doctor decides to give your child any insulin products, he or she may give you special instructions. Do not change the type of insulin you take or your dose, unless your doctor tells you to. If you are at risk of having severely low blood sugar, your doctor may prescribe a glucagon emergency kit. Before using.

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