New Drug Approvals

APRIL 25, 2025

8] Therefore, it may serve as a new addition to combination therapy with conventional cancer treatment, such as chemotherapy. Combining inavolisib with palbociclib and fulvestrant might improve treatment of breast cancer. [14] 15 February 2018). 3] Inavolisib was approved for medical use in the United States in October 2024. [3]

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The Pharma Data

JUNE 24, 2025

We look forward to this strategic alliance continuing to expand the frontiers of cutting-edge science and translating groundbreaking discoveries into transformative treatments for patients.”

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New Drug Approvals

JUNE 15, 2025

Its sodium salt is used for the treatment of generalised myasthenia gravis (a disease that leads to muscle weakness and tiredness) in adults whose immune system produces antibodies against acetylcholine receptors. April 2018). 6] [9] [10] It is a complement inhibitor that is injected subcutaneously (under the skin). [6] 126 (23): 939.

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New Drug Approvals

JUNE 22, 2025

Preparation of pyrrolopyridine-aniline compounds for treatment of dermal disorders. 2018-11-22. [2]. WO2023096935 WO2022262797 WO2020106303 WO2020106304 WO2020106303 WO2020106307 WO2020106304 WO2018213810 WO2020106304 WO2020106303 REF [1]. Kincaid, et al. World Intellectual Property Organization, WO2018213810 A1. Sarin KY, et al.

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Codon

NOVEMBER 3, 2024

In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. Over time, the frequency of resistance gene variants in the population will continue increasing because only the bacteria lacking those variants will die with treatment.

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The Pharma Data

JUNE 23, 2025

While PAD is prevalent among those with type 2 diabetes, dedicated treatments targeting functional outcomes in PAD have been notably absent—until now. He stated, “People living with type 2 diabetes face multiple cardiometabolic challenges, yet there is a lack of treatments that address the full disease spectrum.

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Trials Disease Therapies Treatment 40

FDA Law Blog: Biosimilars

APRIL 7, 2025

Specifically, the Librela ads show before and after treatment with no risk information, thereby making efficacy claims without fair balance, particularly because the Important Safety Information is not visible unless the viewer clicks on the more button to expand the text box.

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Vaccine FDA Production Drugs 65

New Drug Approvals

JULY 8, 2025

It is being investigated as a potential treatment for various herpes infections, including those resistant to traditional antivirals like acyclovir. Pritelivir (development codes AIC316 or BAY 57-1293 ) is a direct-acting antiviral drug in development for the treatment of herpes simplex virus infections (HSV).

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Virus DNA Clinical Trials Treatment 62

New Drug Approvals

APRIL 19, 2025

This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] Treatment of phenol 143 with bromo epoxide 144 in the present of K2CO3 afforded ether 145 in 76% yield. 9] It is used as landiolol hydrochloride. IV -Blocker max.

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Drug Target Review

NOVEMBER 7, 2024

This targeted enhancement not only boosts the body’s natural mechanisms but also holds promise for developing novel treatments in immunology, where modulating immune responses can lead to more effective and durable therapeutic outcomes. In addition, she served as the site head for Bayer’s facility in Berkeley, CA.

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BioPharma Drive: Drug Pricing

JULY 16, 2025

In response, Sarepta stopped selling the treatment to these older, non-ambulatory patients, who it judges are at higher risk of treatment-induced liver damage. Among them are treatments for spinocerebellar ataxia, Huntington’s disease and facioscapulohumeral muscular dystrophy. Track how they’re performing.

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National Institute on Drug Abuse: Nora's Blog

NOVEMBER 25, 2024

Contrary to worries that syringe services programs (SSPs) will encourage or promote drug use, evidence shows that they more often do the opposite, linking people with addiction to effective treatment and even helping prevent overdose deaths. Unfortunately, prejudices against harm-reduction continue to impede the reach of SSPs.

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New Drug Approvals

JULY 7, 2025

5] Following with pimicotinib for tenosynovial giant cell tumor treatment in phase III, pimicotinib has also entered into a phase II trial in June 2023 for cGVHD treatment in China. [6] 2018-11-29. [2]. Cancer Research, 2018, 78(13_Supplement): LB-288-LB-288. [3]. 6] The U.S. mmol) in methanol (10 mL). . Yang S, et al.

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Small Molecule Clinical Trials Licensing Licensing 62

PPD

APRIL 14, 2025

Initially approved for treatment of Type 2 diabetes and later for obesity studies in GLP-1 are now expanding in other indications such as obstructive sleep apnea (OSA), heart failure with preserved ejection fraction (HFpEF) and chronic kidney disease (CKD). It is worth noting that trial ran from 2018 to 2021, before the U.S.

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Clinical Trials Trials Clinical Development Disease 52

FDA Law Blog: Biosimilars

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

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Pharmaceutical Companies Drugs FDA Pharmaceuticals 59

Drugs.com

APRIL 26, 2024

FRIDAY, April 26, 2024 (HealthDay) -- Between 2018 and the spring of 2023, a cluster of clients who had gotten 'vampire facial' microneedling skin treatments at a New Mexico spa were diagnosed with HIV, probably via poorly cleaned instruments, a new.

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New Drug Approvals

JULY 21, 2025

Hetrombopag olamine (6), an oral nonpeptide thrombopoietin receptor (TpoR)agonistdevelopedby JiangsuHengruiPharmaceutical, was approved in China in June2021 for treatment of adult patients with chronic primary immune thrombocytopenia (ITP) and severe aplastic anemiawhohave not responded well to other treatments.46Hetrombopag,

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Small Molecule International Production Treatment 62

Drug Target Review

OCTOBER 11, 2023

Most of these conditions are genetic in origin and the majority have no effective treatment. That includes countless rare peripheral diseases, including many for which there are currently no treatments. Boosting autophagy won’t be the only road to new treatments for rare genetic diseases but it is a vital one to take.

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Drug Target Review

AUGUST 29, 2024

However, these treatments will eventually fail for the majority of patients, so there is a strong need for better CAR therapies. How might the CD5 knockout approach impact the treatment of other types of cancers beyond T-cell lymphoma?

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Therapies Treatment Engineering Molecular Biology 59

The Pharma Data

DECEMBER 17, 2020

18, 2020 /PRNewswire/ — Camurus AB (NASDAQ STO: CAMX) announced today that the Swiss agency for therapeutic products, Swissmedic, has approved weekly and monthly Buvidal ® prolonged release buprenorphine for the treatment of opioid dependence in adults and adolescents from 16 years of age. LUND, Sweden , Dec. About Buvidal.

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Treatment Clinical Trials International Pharmaceutical Companies 52

Advarra

JULY 26, 2022

The 2018 Farm Bill. The 2018 Farm Bill removed hemp from the Controlled Substance Act. Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act.

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Regulations Research FDA FDA Approval 97

Drug Target Review

JANUARY 25, 2024

These findings offer a novel strategy for developing targeted treatments for triple-negative breast cancer, which currently has no approved options. The peptide in development is based on a 2018 Cleveland Clinic discovery and serves as a proof-of-concept for this type of drug for triple-negative breast cancer. Available from: [link]

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Treatment Clinical Trials Science Research 105

Drug Hunter

JUNE 5, 2023

Glecaprevir, or ABT-493, was approved in combination with pibrentasvir (Mavyret) for the treatment of Hepatitis C (HCV) in 2017. RCM in the Medicinal Chemistry of Pacritinib Pacritinib, a kinase inhibitor approved in 2022 for treatment of myelofibrosis, was also synthesized with an RCM in its med. Gonzalez-Bobes, F. Poongavanam, V.;

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Process Chemistry Drugs Production Clinical Development 206

The Pharma Data

NOVEMBER 26, 2020

26, 2020 — In isolated areas of the United States, nurse practitioners are filling an important role in helping people access treatment for opioid addiction, according to a Washington State University (WSU) study. By late 2018, nurse practitioners were writing nearly 20% of buprenorphine prescriptions in rural Oregon, the study found.

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Nurses Treatment Doctors Drugs 52

The Pharma Data

OCTOBER 26, 2020

Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. Over-the-counter treatments fail due to the body’s natural protective system. 25% for dry eye disease treatment.

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Treatment Disease FDA FDA Approval 52

The Pharma Data

JANUARY 11, 2021

-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB System received its first PMA approval in late 2018.

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FDA Approval Treatment FDA Therapies 52

Drug Target Review

NOVEMBER 6, 2023

Advances in research and development and the utilisation of combination treatment strategies are revolutionising the haematology care landscape, but more must be done to address patients’ individual needs. Evolution of Cancer Pharmacological Treatments at the Turn of the Third Millennium. Published 2018 Nov 13.

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The Pharma Data

NOVEMBER 18, 2021

Eli Lilly and Company blazoned that registration is now open for the CHALLENGE-MIG clinical trial, the first and only head-to- head trial comparing twoanti-calcitonin gene- related peptide (CGRP) drugs for the preventative treatment of episodic migraine in grown-ups.1 gepants) may help people achieve the pretensions that count most to them.

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Treatment Clinical Trials Trials Disease 52

FDA Law Blog: Drug Discovery

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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FDA Disease Clinical Pharmacology Science 106

New Drug Approvals

OCTOBER 12, 2024

ALZ-801 is an advanced and markedly improved candidate for the treatment of alzheimer’s disease. 2018; 32(9): 849–861. [2]. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. 2018 Mar;57(3):315-333. 2007 ; Kocis et al.,

Pharmacokinetics 62

Pharmacokinetics Small Molecule Disease Licensing 62

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

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Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

DECEMBER 17, 2020

He’s been off insulin since August 2018 — more than two years. No treatments are approved for reversing type 1 diabetes. WEDNESDAY, Oct. 7, 2020 — After starting a drug that’s officially approved to treat a type of blood cancer, a young man with type 1 diabetes was able to stop using insulin.

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Treatment Doctors Clinical Trials Trials 52

Drug Target Review

NOVEMBER 3, 2023

“Our findings provide crucial insights into the molecular mechanisms that govern cell fate decisions in the human gut, which is essential for understanding these conditions and ultimately developing treatments,” Lin said. 2018 February 8 [2023 November 1];172(4):650-65. The study was published in Science. Cell [Internet].

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The Pharma Data

MARCH 13, 2021

“Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity, with a proven efficacy and safety profile as a preventive treatment for HAE attacks. Subject to approval, we are looking forward to providing lanadelumab as a new treatment option for patients in Japan living with HAE.”.

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Treatment Pharmacokinetics Drugs Production 52

The Pharma Data

MARCH 30, 2021

2] – The atogepant application demonstrates AbbVie’s longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine. .

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Treatment FDA Doctors Drugs 52

Drug Target Review

FEBRUARY 28, 2024

Over the past 25 years, T-cell therapies have gained significant ground in the treatment of cancer. Trends Immunol 39(6):446-459 (2018). Nat Commun 9(1):1760 (2018). A combined treatment regimen of MGMT-modified γδ T cells and temozolomide chemotherapy is effective against primary high grade gliomas. Fisher J, Anderson.

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Therapies Engineering Molecular Biology Science 105

Drug Target Review

AUGUST 24, 2023

We will explore how GDF-15 impacts the tumour microenvironment and hinders the infiltration of T cells into the tumour, as well as the implications of neutralising GDF-15 to reverse its inhibitory effects and sensitise tumours to anti-PD-1 treatment. T-cell infiltration is a prerequisite for responses to checkpoint inhibitors.

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