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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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. Most men with mHSPC will eventually progress to CRPC, which has poor survival prospects.

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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. Numerous compounds are currently under clinical investigation for MASH.

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pharmaphorum

AUGUST 28, 2020

An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company.

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Delveinsight

AUGUST 31, 2021

FDA’s Green Flag to Ascendis’s Once-Weekly SKYTROFA for Treatment of Pediatric Growth Hormone Deficiency. Growth Hormone Deficiency , commonly known as dwarfism, can constitute short stature and complications with metabolism, which arise due to inadequate production of growth hormones by the pituitary gland inside the body.

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Drug Discovery World

NOVEMBER 16, 2022

Secreted proteins are a proven class of biologics with largely underutilised therapeutic potential, despite the impact of FDA-approved biologics based on secreted proteins such as insulin, human growth hormone, and erythropoietin.

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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.

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pharmaphorum

JULY 19, 2022

billion for AZ last year across its eight FDA-approved indications, while Merck booked $989 million from its share of profits from the drug. In the first quarter, the drug claimed another important approval in adjuvant therapy of breast cancer.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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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.

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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. The latest approval extends the potential benefits of this combination to treat patients with any type of solid tumor, expanding upon its previous indications.

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XTalks

FEBRUARY 5, 2024

Revlimid (Lenalidomide) Revlimid 2022 sales: $9.978 billion Company/Developer: Bristol Myers Squibb Date of first FDA approval: December 27, 2005 Indications Revlimid is FDA-approved for: Myelodysplastic disease (MDS), multiple myeloma, mantle cell lymphoma (MCL), follicular lymphoma and marginal zone lymphoma.

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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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XTalks

SEPTEMBER 17, 2020

Often, the potential patient pool for a given trial is small and the unmet need is high, incentivizing drugmakers and regulators to find innovative ways to make game-changing therapeutics available to those who need them most. Symptoms and Etiology: Caused by an overproduction of growth hormone, acromegaly primarily affects adults.

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Drug Discovery World

JUNE 12, 2024

The hormone GLP-1 (glucagon-like peptide-1) and its receptor agonists (GLP-1RAs) have emerged as a compelling class of drugs to tackle diabetes, particularly due to their remarkable efficacy in lowering obesity levels, a fundamental contributing factor of type 2 diabetes.

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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

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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. It was also given FDA priority review. billion to $1.28

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The Pharma Data

FEBRUARY 8, 2021

Metastatic castration-sensitive prostate cancer, also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that still responds to hormonal therapy and has spread beyond the prostate to other parts of the body. [4]. About Metastatic Castration-Sensitive Prostate Cancer. About ERLEADA ® (apalutamide).

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FDA Law Blog

OCTOBER 28, 2021

Butler — Having a hand in the FDA approval of important new prescription drugs is one of the things that makes our work at HPM so gratifying. Other considerations might include the specific hormones in the product, the levels of hormones, the side effect profile, ease of use, and the ability to comply with the labeled regimen.

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Drug Discovery World

MAY 9, 2024

RA: Tell us how OXE103 works? MW: OXE103 (ghrelin) is a 28 amino acid neuro-peptide hormone that crosses the blood brain barrier and is responsible for maintaining brain energy homeostasis and neuroprotection related to neuronal cell preservation, axonal connectivity and decreased inflammation.

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The Pharma Data

JULY 22, 2021

In accordance with accelerated approval regulations, continued approval was contingent upon verification and description of clinical benefit; these accelerated approval requirements have been fulfilled with the data from KEYNOTE-775/Study 309.

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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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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Bemarituzumab. Tarlatamab (AMG 757). AMG 451 / KHK4083.

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The Pharma Data

MARCH 3, 2021

Food and Drug Administration (FDA) approved Pfizer Inc.’s LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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Drug Discovery World

AUGUST 21, 2023

However, because these cancers are not driven by any of the three molecules that can be blocked by targeted hormone receptor drugs, current treatment options are limited. The regulator had already approved the combination treatment in advanced cancers the previous year.

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Pfizer

JANUARY 27, 2023

and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. It is important to note that these studies are required by U.S. and around the world.

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Intouch Solutions

AUGUST 5, 2021

This then leads many of those same people to online forums like the TransDIY subreddit that’s dedicated to do-it-yourself hormone replacement therapy, or DIY HRT. DIY HRT is a combination of non-prescribed, often unregulated, hormone medicines and self-performed surgeries that are administered without the supervision of an HCP.

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The Pharma Data

JUNE 24, 2021

The FDA approval of MYFEMBREE represents a significant milestone in expanding treatment options for uterine fibroids, a chronic and debilitating disease for many women in the U.S.” . Pacific Time to discuss the FDA approval of MYFEMBREE®. Uterine fibroids affect millions of women in the U.S. Eastern Time, Monday–Friday.

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. The safety profile was consistent with prior studies of ERLEADA ® , with no new safety signals observed. 2 ERLEADA ® received U.S. ERLEADA ® is taken orally, once daily, with or without food.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. Isolated growth hormone deficiency. ? BTK signaling is needed by specific cancer cells to multiply and spread. 2010; 116(20): 4777–4787.

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The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.

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The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. Isolated growth hormone deficiency. ? BTK signaling is needed by specific cancer cells to multiply and spread. 2010; 116(20): 4777–4787.

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The Pharma Data

MAY 4, 2021

Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Somatrogon — In February 2021, Pfizer and OPKO Health Inc.

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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. T3 is a major hormone in the blood that regulates thyroid levels.

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XTalks

MAY 20, 2022

Eli Lilly’s diabetes and weight loss shot tirzepatide, known by its trade name Mounjaro, received a much-anticipated nod from the US Food and Drug Administration (FDA) last week for the treatment of diabetes. The injection is intended to regulate blood sugar, in conjunction with diet and exercise, in adults with type 2 diabetes.

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