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 105

XTalks

JANUARY 29, 2025

Related: Eli Lillys Zepbound Approved as First Treatment for Obstructive Sleep Apnea The commercial describes Zepbounds mechanism of action as a dual receptor against that works by activating two naturally occurring hormone receptors in [the] body [GLP-1 and GIP-1]. Its changing how much weight I lose, up to 48 lbs, he says.

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FDA Approval Drugs Hormones Marketing 71

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

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

XTalks

JANUARY 16, 2025

It is a complication of Graves disease, an immune system condition that causes the thyroid gland to make excess amounts of thyroid hormone. It will rival Amgens Tepezza (teprotumumab-trbw), which became the first approved treatment for thyroid eye disease with its FDA approval in 2020.

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Trials Clinical Trials Clinical Trials Insulin 59

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

XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

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Research Hormones Protein Regulation 98

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

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 98

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

NOVEMBER 3, 2022

Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDA approval and expanding insurance coverage. Mounjaro has thus taken off stronger than expected, surpassing Wall Street sales forecasts during the third quarter.

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Sales FDA Approval Production Insulin 98

XTalks

NOVEMBER 10, 2021

Related: GSK’s Dostarlimab Wins FDA Approval for dMMR Endometrial Cancer. Darbepoetin alfa is a synthetic version of the hormone erythropoietin, which is made in the kidneys and stimulates the production of red blood cells (RBC), or erythrocytes. What is Daprodustat?

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Trials Hormones Drugs FDA Approval 97

XTalks

JULY 19, 2024

Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss.

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Pharmacy Drugs Production Sales 104

XTalks

SEPTEMBER 6, 2024

Lutathera is used to treat adults and children aged 12 years and older with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that are positive for the hormone receptor somatostatin, including GEP-NETs in the foregut, midgut and hindgut. The company is currently constructing a facility in China and is also planning for one in Japan.

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Development Manufacturing Marketing Hormones 105

XTalks

FEBRUARY 3, 2023

Until now, fulvestrant was the only other selective estrogen receptor degrader (SERD) therapy approved for ER+ breast cancer, delivered via intramuscular injections. Current treatments include hormonal therapies that focus on blocking the function of the estrogen receptor, curbing its production or degrading the receptor itself.

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Clinical Trials Clinical Trials FDA Approval Trials 97

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

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

pharmaphorum

DECEMBER 23, 2020

It has been a year dominated by the pandemic and many life sciences research projects were put on hold as big pharma turned its attention to vaccines and therapies. NT-814 is a non-hormonal drug that works on the neurokinin (NK) 1,3 receptor antagonist, thus treating the vasomotor symptoms associated with the menopause.

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Marketing Gene Gene Silencing Drugs 96

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

XTalks

JUNE 10, 2024

Efruxifermin is a novel Fc-FGF21 fusion protein designed to emulate the activity of native FGF21, an endogenous hormone that regulates metabolism and alleviates cellular stress. MASH is intricately linked to cardiovascular, kidney and metabolic disorders. This comprehensive action of efruxifermin addresses the multifaceted nature of MASH.

Insulin 52

Insulin Life Science Regulation Hormones 52

XTalks

SEPTEMBER 17, 2020

Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults. By reducing the amount of growth hormone in the blood, progressive enlargement of bones should be slowed. By reducing the amount of growth hormone in the blood, progressive enlargement of bones should be slowed.

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Trials Gene Hormones Clinical Trials 98

XTalks

NOVEMBER 9, 2023

Eli Lilly is now fully armed on the GLP-1 front as it’s finally received US Food and Drug Administration (FDA) approval for Zepbound (tirzepatide), its obesity version of Mounjaro. The FDA approved Zepbound for chronic weight management in adults with obesity.

FDA Approval 59

FDA Approval Manufacturing Drugs Pharmacy 59

XTalks

SEPTEMBER 12, 2024

Xtandi for Non-Metastatic Prostate Cancer In late 2023, Pfizer and Astellas’ Xtandi (enzalutamide) received the US Food and Drug Administration (FDA) approval for use in non-metastatic castration-sensitive prostate cancer (nmCSPC) patients. Prostate Cancer Awareness Month is a time to act.

Research 52

Research Clinical Trials Clinical Trials Hormones 52

XTalks

MARCH 8, 2024

Risk factors include aging, hormonal changes, low body weight, low calcium intake and use of certain medications. It occurs when the formation of new bone doesn’t keep up with the loss of old bone. The disease often progresses without symptoms until a fracture happens, typically in the wrist, hip or spine.

Drugs 59

Drugs FDA Approval Production Immune Response 59

XTalks

FEBRUARY 21, 2024

There are currently no FDA-approved drug therapies for MASH, and the disease is characterized by excess fat accumulation and inflammation in the liver, which leads to liver scarring or fibrosis. MASH is known to occur in an estimated three to five percent of adults in the US.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Insulin 59

XTalks

OCTOBER 11, 2023

They mimic the action of GLP-1, a hormone that helps regulate blood sugar levels by enhancing insulin secretion. Ozempic and Wegovy continue to be blockbusters for Novo, despite facing competition from Eli Lilly’s dual GLP-1/GIP agonist Mounjaro (tirzepatide), which won FDA approval in May 2022.

Drugs 59

Drugs Insulin Hormones FDA Approval 59

XTalks

MARCH 15, 2023

FDA-approved ADHD-specific non-stimulants are a relatively newer class of medication designed to treat ADHD that have much fewer side effects than stimulants. Norepinephrine is a hormone and neurotransmitter that helps in alertness and maintaining control in high-stress situations.

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Drugs Sales Trials Marketing 98

XTalks

JUNE 27, 2022

Novartis’ Tafinlar and Mekinist received FDA approval for the treatment of unresectable or metastatic solid tumors with the BRAF V600E mutation. Novartis is also investigating several other medications for tumors and solid tumors, many of which are in Phase III trials.

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Clinical Trials Clinical Trials Trials Gene 52

XTalks

MAY 10, 2023

The exact cause of lupus is not entirely understood, but it is thought to be from a combination of genetic, environmental and hormonal factors. Lupkynis (voclosporin), developed by Aurinia Pharmaceuticals, is a calcineurin inhibitor that was approved by the FDA in 2021 for the treatment of adults with active lupus nephritis (LN).

Drugs 52

Drugs Clinical Trials Clinical Trials Antibody 52

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

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Sales Manufacturing FDA Approval Life Science 98

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.

FDA Approval 97

FDA Approval Clinical Trials Clinical Trials Trials 97

XTalks

NOVEMBER 12, 2024

Pancreatic cancer occurs when cells in the pancreas, a vital organ responsible for producing enzymes and hormones, begin to grow uncontrollably. This approval allows Onivyde to be used earlier in the treatment process, offering new options for patients with advanced disease.

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Research FDA Approval Trials Clinical Trials 105

XTalks

JANUARY 30, 2025

Novartis has spent three decades advancing breast cancer treatments, focusing on hormone receptor-positive (HR+), HER2-negative breast cancer, the most common subtype. Last year, the FDA approved Kisqali (ribociclib) to reduce the risk of recurrence in HR+/HER2- early breast cancer.

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HR Hormones FDA Approval Clinical Trials 64

XTalks

FEBRUARY 19, 2021

Evofem Biosciences announced the launch of their new national campaign called, “Get Phexxi,” designed to raise awareness about the company’s non-hormonal birth control method. In May 2020, the US Food and Drug Administration (FDA) approved Phexxi , a non-hormonal contraceptive for women.

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Hormones Production FDA Approval Marketing 88

XTalks

MAY 17, 2023

Astellas Pharma recently announced the US Food and Drug Administration (FDA) approval of their new medication, Veozah (fezolinetant) for the treatment of moderate to severe hot flashes and night sweats due to menopause. Hormone replacement therapy is thought to be one of the most effective treatments for vasomotor symptoms.

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Hormones FDA Approval Drugs Clinical Trials 95

XTalks

NOVEMBER 20, 2023

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. billion to $1.28

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HR FDA Approval Gene Trials 98

XTalks

NOVEMBER 2, 2020

This includes compromising the functioning of the adrenal glands, which can potentially lead to adrenal insufficiency, resulting in inadequate production of steroid hormones. Fasenra is also looking to get FDA approval for chronic rhinosinusitis with nasal polyps, as is GlaxoSmithKline’s Nucala.

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Trials FDA Approval Drugs Hormones 94