Pharmaceutical Technology

MARCH 6, 2023

The US Food and Drug Administration (FDA) has granted approval for the expanded indication for Eli Lilly and Company ’s (Lilly) Verzenio (abemaciclib) to treat breast cancer patients. The post US FDA approves expanded indication for Lilly’s breast cancer therapy appeared first on Pharmaceutical Technology.

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FDA Approval HR Hormones Clinical Trials 130

XTalks

JULY 26, 2024

Norethindrone acetate and ethinyl estradiol are legacy drugs that have been approved since 1968 in a swallowable tablet form for the prevention of pregnancy. The tablet consists of two hormones: norethindrone acetate, a type of progestin, and ethinyl estradiol, a synthetic form of estrogen.

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FDA Approval Hormones Containment Drugs 52

The Pharma Data

APRIL 28, 2023

FDA approves once-weekly Sogroya® for the treatment of children living with growth hormone deficiency Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Sogroya ® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg for the treatment of children aged 2.5

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Hormones FDA Approval In-Vivo Production 40

BioSpace

NOVEMBER 16, 2023

Xtandi is now approved to treat nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis with or without a gonadotropin-releasing hormone analog therapy.

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FDA Approval Hormones 99

Pharmaceutical Technology

MAY 15, 2023

The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. However, the use of hormone replacement therapy comes with its set of challenges.

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Hormones FDA Approval Licensing Licensing 244

XTalks

FEBRUARY 6, 2023

GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months.

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FDA Approval Clinical Trials Clinical Trials Trials 92

BioTech 365

DECEMBER 18, 2020

Myovant Sciences Announces FDA Approval of ORGOVYX™ (relugolix), the First and Only Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer Myovant Sciences Announces FDA Approval of ORGOVYX™ (relugolix), the First and Only Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced (..)

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Hormones FDA Approval 40

The Pharma Data

DECEMBER 21, 2020

Because prostate cancer is fueled by testosterone production, both drugs decrease levels of the hormone in the body. . Orgovyx works by blocking the pituitary gland from making hormones that signal the amount of testosterone the body is able to make, causing medical castration.

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Hormones FDA Approval Drugs Production 52

BioSpace

NOVEMBER 7, 2023

Lilly’s Zepbound (tirzepatide) injection is the first and only approved treatment that activates two incretin hormone receptors, GIP and GLP-1, to treat obesity and excess weight.

FDA Approval 54

FDA Approval Hormones 54

XTalks

OCTOBER 18, 2024

The US Food and Drug Administration (FDA) has approved Itovebi (inavolisib) for the treatment of adults with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation.

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HR FDA Approval Hormones Compliance 103

pharmaphorum

MAY 16, 2022

GLP-1 and GIP are hormones involved in blood sugar control and Mounjaro, a first-in-class medicine that activates both GLP-1 and GIP receptors, demonstrated improved blood sugar control. The post Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval appeared first on.

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FDA Approval Insulin Drugs Hormones 115

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. BASEL, Switzerland, Dec. Indication.

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Hormones FDA Approval Containment Medicine 52

BioSpace

DECEMBER 21, 2020

Myovant's oral Orgovyx beat out Abbvie's injectable Lupron in achieving medical castration levels in patients.

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Hormones FDA Approval Drugs 106

BioSpace

AUGUST 25, 2021

Food and Drug Administration (FDA) approved Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd) for children one year and older who have growth failure from inadequate secretion of endogenous growth hormone (GH).

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Hormones FDA Approval Drugs 93

XTalks

JUNE 20, 2022

Amvuttra’s FDA approval is based on positive data from the global, randomized, open-label, multicenter HELIOS-A Phase III study from a period of nine months. TTR is made in the liver and is involved in carrying the thyroid hormone thyroxine (T4) and retinol (vitamin A) to the liver.

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FDA Approval Protein Genetics RNA 98

XTalks

MAY 26, 2022

In this episode, Ayesha discussed the FDA approval of Eli Lilly’s diabetes injection Mounjaro (tirzepatide) for the treatment of adults with type 2 diabetes This is a great advancement in the diabetes space as Mounjaro is a first-in-class medicine that targets the activity of two hormones involved in hunger and blood sugar control (GLP-1 and GIP).

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Life Science FDA Approval Hormones Sales 52

Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

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HR Hormones FDA Approval Antibody 264

XTalks

JULY 17, 2024

Sweden-based biotech Camurus shared positive Phase III trial data for CAM2029, one of its lead candidates, in patients with the rare hormonal disorder acromegaly. Octreotide is a synthetic analog of somatostatin, a hormone in the body that inhibits the release of several other hormones, including growth hormone (GH), glucagon and insulin.

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Trials Hormones Clinical Trials Clinical Trials 59

XTalks

JUNE 29, 2023

This episode features an interview with Marci English, Vice President and Head of BioPharma Development at Astellas Pharma, about the recent FDA approval of the company’s drug Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause.

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Life Science Hormones FDA Approval Development 52

pharmaphorum

SEPTEMBER 15, 2021

If approved, linzagolix will be the only drug in the class with a dosing regimen intended for women with uterine fibroids who cannot or do not want to take hormone therapy, as well as options for those women happy to do so, according to ObsEva.

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Hormones Drugs FDA Approval Sales 98

The Pharma Data

NOVEMBER 21, 2021

The FDA approved Voxzogo under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need, based on a surrogate or intermediate clinical endpoint. 3] Achondroplasia is caused by mutations in the FGFR3 gene. Inheritance is autosomal dominant.[1][2]

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FDA Approval Drugs Regulation Genetics 52

XTalks

AUGUST 22, 2024

Yorvipath, developed using Ascendis Pharma’s TransCon technology, is the first and only approved treatment for hypoparathyroidism, marking this approval as a major milestone. Hypoparathyroidism arises when the parathyroid glands fail to produce enough parathyroid hormone (PTH) or when the PTH produced is ineffective.

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Hormones FDA Approval Trials Clinical Trials 52

Pharmaceutical Technology

MARCH 7, 2023

Medical interventions typically recommended during this stage include drugs to treat depression and hormone replacement therapies (HRT). Moreover, women with various existing conditions cannot take hormone therapies, and SSRIs and SNRIs may not always be effective. If the conditions are mild, hormone therapy may help,” says Santoro.

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Hormones Scientist Drugs Research 130

XTalks

OCTOBER 25, 2023

Genevieve Neal-Perry, MD, PhD, professor and chair at the UNC School of Medicine Department of Obstetrics and Gynecology, and lead investigator on a study investigating Astellas Pharma’s fezolinetant (Veozah), which received FDA approval in May this year for the treatment of moderate to severe vasomotor symptoms due to menopause.

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Life Science Trials FDA Approval Hormones 52

pharmaphorum

JANUARY 17, 2022

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. Partnering with EraCal builds upon the success of Novo Nordisk’s Wegovy (semaglutide) chronic weight management drug, which was approved by the FDA in June 2021.

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FDA Approval In-Vitro Regulation Hormones 123

XTalks

NOVEMBER 9, 2022

Since Mounjaro’s May US Food and Drug Administration (FDA) approval, sales of the drug have skyrocketed beyond initial expectations owing to patient demand and a temporary shortage of Novo’s Ozempic. Mounjaro and Ozempic are both FDA approved for glycemic control in adults with type 2 diabetes, in combination with diet and exercise.

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Insulin Hormones FDA Approval Sales 98

The Pharma Data

SEPTEMBER 1, 2021

The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. Your healthcare provider may do blood tests during the first few months of treatment with INVEGA HAFYERA™.

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FDA Approval Medicine Clinical Trials Clinical Trials 52

pharmaphorum

JANUARY 26, 2023

Merck has said it will abandon the KEYNOTE-991 study of PD-1 inhibitor Keytruda (pembrolizumab) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) after it showed no benefit on either overall survival (OS) or radiographic progression-free survival (rPFS) when the data was analysed midway though.

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Hormones Trials FDA Approval Clinical Development 59

XTalks

FEBRUARY 7, 2023

The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director, SurvivingBreastCancer.org, in the press release.

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HR Hormones FDA Approval Antibody 52

The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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FDA Approval Hormones Production Drugs 52

pharmaphorum

DECEMBER 1, 2021

Current treatments are dominated by generic drugs, and include topical antiseptics, retinoids which work by removing dead skin cells from the surface of the skin but can cause pain and inflammation, and topical antibiotics, as well as hormonal therapies including oral androgen inhibitors like spironolactone or cyproterone.

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Vaccination Vaccine Development Hormones 105

pharmaphorum

FEBRUARY 1, 2021

If approved by the European Commission in the coming weeks, Kesimpta will offer patients with relapsing disease a treatment option that can be self-administered every month through an auto-injector pen.

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Drugs Hormones FDA Approval Clinical Trials 98

Pharmaceutical Technology

OCTOBER 13, 2022

The drug won its original FDA approval in May last year to treat heavy menstrual bleeding that accompanies uterine fibroids in premenopausal women. Myfembree is a combination therapy that includes relugolix, estradiol and norethindrone acetate.

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Hormones FDA Approval Drugs Marketing 130

XTalks

JUNE 5, 2023

Semaglutide acts as a glucagon-like peptide-1 (GLP-1) receptor agonist, mimicking the GLP-1 hormone released in the gastrointestinal tract after eating. Patients and healthcare professionals should understand that certain semaglutide products may not contain the same active ingredient as FDA-approved semaglutide.

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FDA Approval Containment Drugs Pharmacy 95

XTalks

APRIL 29, 2022

Tirzepatide is a novel investigational obesity treatment that contains mimetics of two hormones that are involved in regulating appetite in a single peptide: a GIP (glucose-dependent insulinotropic polypeptide) receptor agonist and a GLP-1 (glucagon-like peptide-1) receptor agonist. percent and 22.5 percent, respectively, compared to placebo.

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Trials Drugs FDA Approval Clinical Trials 98

Delveinsight

JANUARY 5, 2021

Pfizer and OPKO Health: A step closer to FDA Nod for pediatric growth hormone deficiency (GHD) drug, Somatrogon. Pfizer and Opko had joined hands in 2014 to develop somatrogon , a pediatric growth hormone deficiency (GHD) drug. FDA Emergency Use Authorization for SCONE Medical’s Novel Aerosol Infection Containment Device.

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Hormones FDA Approval Drugs Trials 52

XTalks

AUGUST 15, 2023

Akeega is approved for use with the corticosteroid prednisone in adults with BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. Lynparza received FDA approval in May 2020 for mCRPC in patients with homologous recombinational repair ( HRR ) gene mutations.

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FDA Approval Gene Hormones Drugs 52