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1] [2] It is a non- opioid , small-molecule analgesic that works as a selective inhibitor of Na v 1.8 1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] The FDA has long supported development of non-opioid pain treatment.
g/mol O5ZD2TU2B7 FDA 7/3/2025, Ekterly, To treat acute attacks of hereditary angioedema N -[(3-fluoro-4-methoxypyridin-2-yl)methyl]-3-(methoxymethyl)-1-[[4-[(2-oxopyridin-1-yl)methyl]phenyl]methyl]pyrazole-4-carboxamide Sebetralstat , sold under the brand name Ekterly , is a medication used for the treatment of hereditary angioedema. [1]
CAR-T therapy (perhaps the most promising cancer treatment of the last several decades) is one example, in which scientists extract a patient’s blood cells, modify T cells so they can recognize and attack malignancies more effectively, and reinfuse them back into the body.
Formula C 27 H 29 Cl 2 FN 2 OS Crinecerfont , sold under the brand name Crenessity , is a medication used for the treatment of congenital adrenal hyperplasia. [1] 2] Crinecerfont was approved for medical use in the United States in December 2024. [2] 2] Crinecerfont was approved for medical use in the United States in December 2024. [2]
Table 1: Smallmolecule drugs approved by the FDA in 2023 with reported involvement of phase II mechanisms In vitro : In vivo differences Incubation of the SGLT2 (sodium-glucose co-transporter-2) inhibitor bexagliflozin in human liver microsomes points to metabolism through both oxidation and glucuronidation to 6 main metabolites.
Metabolism of 2022 FDAapprovedsmallmolecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the smallmolecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Dermavant’s tapinarof is one such friend.
Metabolism of 2023 FDAApprovedSmallMolecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 smallmolecules out of a total of 55 new drugs [1]. References [1] 2023 Novel SmallMoleculeFDA Drug Approvals.
FDAApproves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S.
Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists.
In addition, we have advanced zavegepant, our intra-nasal CGRP receptor antagonist, successfully through its first pivotal trial, also for the acute treatment of migraine.
TOKYO and CAMBRIDGE, England , Dec.
Since the drug conjugated to mAb, typically a highly cytotoxic smallmolecule, can be released unconjugated in plasma and contribute to drug-drug interaction (DDI) potential, both the antibody and smallmolecule drug component are considered from the perspective of ADC safety.
Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.
Read the Pre-print Rare Roundup A seemingly small semantic issue is a major roadblock to develop treatments for rare diseases We’ve spoken often about the goal of repurposing existing drugs to better treat KAND – this is a reality for many families who utilize off-label prescriptions. * What’s a pre-print?
.–( BUSINESS WIRE )– Veralox Therapeutics, a biotechnology company developing first-in-class smallmolecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced that the U.S. Boxer, PhD, Chief Operating Officer of Veralox Therapeutics. About VLX-1005.
November 25, 2020 — Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). The approval of remdesivir ( Veklury ) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard. Source: FDA.
How have advancements in antibody-drug conjugates (ADCs) expanded treatment options for different types of cancer? The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinical development.
Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. Sanofi has entered into a definitive merger agreement with Kadmon Holdings, Inc.
Urovant’s lead drug candidate, vibegron, is an oral, once-daily smallmolecule beta-3 agonist being evaluated for the treatment of OAB, abdominal pain associated with irritable bowel syndrome (IBS) in men with OAB, and for men suffering from OAB with benign prostatic hyperplasia (BPH).
2 On December 6th, 2023, Iptacopan under the brand name Fabhalta was approved by the FDA for the treatment of adults with PNH. This approval was based on favorable results obtained from the phase III APPL-PNH and APPOINT-PNH studies, where 82.3% 1] It is a complement factor B inhibitor that was developed by Novartis. [1]
Acoltremon AR-15512 CAS 68489-09-8 WeightAverage: 289.419 Monoisotopic: 289.204179113 Chemical FormulaC 18 H 27 NO 2 FDA 2025, 5/28/2025, To treat the signs and symptoms of dry eye disease Tryptyr WS-12 WS 12 (1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide Fema No. 284 (7): 4102–4111. 28 May 2025.
“HER-MES is the first study that directly compared the therapeutic effects of an antibody and a smallmolecule in migraine prevention,” said Uwe Reuter, M.D., “The positive outcomes strengthen the efficacy and safety profile of erenumab as a migraine prevention treatment for patients with migraine.”
Convergent is currently conducting advanced human trials relating to prostate cancer treatments involving peptide receptor radionuclide therapy (“PRRT”) that targets the prostate-specific membrane antigen (“PSMA”) present on prostate cancer cells. as a single agent treatment for prostate cancer.
FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.
1] [2] Levacetylleucine was approved for medical use in the United States in September 2024. [1] 1] [2] [3] Levacetylleucine is the second medication approved by the US Food and Drug Administration (FDA) for the treatment of Niemann-Pick disease type C. [2] 2] The FDA considers it to be a first-in-class medication. [4]
LYT-100 is an anti-fibrotic and anti-inflammatory oral smallmolecule that has been designed to overcome the tolerability challenges associated with pirfenidone, an anti-inflammatory, anti-fibrotic drug currently on the market. The trial is ongoing in the U.S. and Europe, and PureTech Head of Innovation, Dr. Michael C.
Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The company is developing its platform for the treatment of chronic, inflammation-mediated autoimmune diseases, and is initially focused on the treatment of RA.
Specifically, after 2 to 4 weeks of treatment with this combination of two correctors and a potentiator, such patients experienced about a 10 percentage point improvement in forced expiratory volume in 1 second (FEV1), which is a key measure of lung capacity. About 30,000 Americans have CF.
With PRISM, it’s now feasible to screen entire smallmolecule libraries across large panels of cancer cell lines. The approach might also be put to use for optimizing drug candidates or for discovering new uses for cancer drugs that have already been FDAapproved.
Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDAAPPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]
Overviews of clinical trials and scientific rationale will be presented at MSVirtual2020, the 8th Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from 11-13 September 2020. “We
The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
New data further reinforce OCREVUS (ocrelizumab) as a highly effective treatment option offering a favourable and consistent benefit:risk profile, with high treatment persistence and adherence. Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations.
As FDA explains, Boehringer’s request would allow its “Cyltezo (adalimumab-adbm) injection, which contains the same total content of drug substance and same concentration as Original Concentration Humira (e.g., solid oral dosage forms),” which, FDA posits, suggests “that the terms have overlapping meanings.”
As a reminder, there currently is no FDAapproval pathway to develop a generic or biosimilar copy of a cell therapy product, which provides a significant barrier-to-entry from generic competition.
Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. BNT162b2 (SARS-CoV-2 vaccine) FDAApproval History. Source: Pfizer Inc. . Posted: November 2020. Source link.
AbbVie announced that the European Commission (EC) has approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS). Recent Events. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc. AbbVie announced that the U.S.
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer BioNTech COVID-19 Vaccine.
BNT162b2 (SARS-CoV-2 vaccine) FDAApproval History. Source: Pfizer Inc. . Posted: December 2020.
Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. BNT162b2 (SARS-CoV-2 vaccine) FDAApproval History. Source: Pfizer, inc. Posted: November 2020. Source link.
A few years ago, at Arrakis Therapeutics, we set out to conquer a strange new territory, drugging RNA structures with smallmolecules. On the strength of those findings, nusinersen was approved by the FDA at the end of 2016 for the treatment of SMA , marketed under the commercial brand Spinraza.
Precision medicine developer Kura Oncology is positioned to make a meaningful difference in the treatment of cancer in the next few years with its two, wholly-owned, smallmolecule compounds. Kura Oncology CEO Troy Wilson pictured above. Photo courtesy of Kura. Tipifarnib is a farnesyltransferase inhibitor (FTI).
A Brief History of Targeted Cancer Drugs In 1978, FDAapproved the first targeted cancer drug, tamoxifen. The FDAapproved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998. The FDAapproved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998.
Immunotherapy has revolutionized cancer treatment and proved to be pivotal in the field of oncological research. To date, the only FDAapproved immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway are monoclonal antibodies (mAbs).
If approved, rimegepant will be the first oral CGRP receptor antagonist in the EU, and the only migraine medication approved for both acute and preventive treatment. There is a significant unmet need for new treatments as more than 90 percent of people with migraine are unable to work or function normally during an attack.
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials.
21 December 2020 — AstraZeneca’s Tagrisso ( osimertinib ) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent. 0.23; p<0.0001).
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