Chemical Biology and Drug Design

OCTOBER 24, 2023

However, potent FDA-approved inhibitors were identified against druggable PmrB-pocket, bypassing the mutation loci. In the present study, clinical isolates of K. pneumoniae pneumoniae. However, the dynamic genomic landscape of colistin-resistant K. pneumoniae pneumoniae. μg/mL for resistant and ≤0.25 μg/mL

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ASPET

AUGUST 4, 2023

Sodium 2-mercaptoethane sulfonate (mesna) is an organosulfur compound that is currently FDA-approved for decreasing the toxicity of mustard-derived chemotherapeutic alkylating agents like ifosfamide and cyclophosphamide.

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The Pharma Data

OCTOBER 27, 2020

Cowen Virtual Presentation Series – 2020 IO Next Summit at 1:15 p.m. (NASDAQ: REGN ) will webcast management participation as follows: Credit Suisse 29 th Annual Virtual Healthcare Conference at 8:45 a.m. EST on Monday, November 9, 2020. EST on Friday, November 13, 2020. Jefferies Virtual London Healthcare Conference at 7:20 a.m.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Oxidation of adagrasib occurs on the methylpyrrolidine group 4. Gut 1996; 38: 439-446.

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The Pharma Data

OCTOBER 29, 2021

Novartis blazoned moment that the US Food and Drug Administration (FDA) approved Scemblix ® (asciminib) for the treatment of habitual myeloid leukemia (CML) in two distinct suggestions. Scemblix is presently available for croakers to define to applicable cases in the US. sites/www.novartis.us/files/scemblix.pdf.

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The Pharma Data

DECEMBER 16, 2020

NASDAQ: REGN) will webcast its presentation at the 39 th Annual J.P. The presentation is scheduled for 8:20 a.m. TARRYTOWN, N.Y. , 16, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Morgan Healthcare Conference on Monday, January 11, 2021.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. Related Articles: Danyelza (naxitamab-gqgk) FDA Approval History. NEW YORK, Nov. Source link.

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The Pharma Data

DECEMBER 1, 2020

Presentations will be available for registered attendees via the Piper Sandler conference site through December 3. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. VICTORIA, British Columbia–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc.

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New Drug Approvals

JUNE 11, 2025

However, in 2012 it once again failed to convince the FDA of its qualities for treating anxiety and depression. [5] 5] In December 2015, the FDA once again gave gepirone a negative review for depression due to concerns of efficacy. [12] 12] However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review. [13]

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The Pharma Data

FEBRUARY 24, 2022

Allergan, an AbbVie (NYSE: ABBV) company, today announced new data to be presented from Allergan’s leading portfolio of eye care treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting being held in Nashville, TN and virtually from March 3-6. The DURYSTA data presentations coincide with the two-year anniversary of the U.S.

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ASPET

SEPTEMBER 20, 2024

Despite considerable efforts, there remains no FDA-approved medications for cocaine use disorder (CUD). The present studies evaluated the reinforcing effects of both compounds in monkeys under several conditions. One strategy to mitigate cocaine craving and relapse is to elevate dopamine (DA). mg/kg/injection), and JJC8-091 (0.1-3.0

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The Pharma Data

MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. Pipeline Highlights. Retevmo (selpercatinib). Abstract Number: CT011. Alimta (pemetrexed).

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The Pharma Data

AUGUST 7, 2021

Pompe disease affects an estimated 3,500 people in the United States and can present as infantile-onset Pompe disease (IOPD), the most severe form of Pompe disease with rapid onset in infancy, and late-onset Pompe disease (LOPD), which progressively damages muscles over time. LOPD symptoms may present at any age.

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ASPET

JUNE 27, 2024

Background: Endocannabinoids, which are present throughout the central nervous system (CNS), can activate CB1 and CB2 receptors. Drug Liking and all other VAS outcomes were greatest for nabilone 3mg and 6mg, which is a currently FDA-approved medication. However, careful evaluation of abuse potential is necessary.

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SugarCone Biotech

JUNE 19, 2025

The results were remarkable for this very sick patient population, with a median OS of 14 months at the dose of 10 mg given every 2 weeks: The data supported FDA approval, in May 2024, of tarlatamab for refractory ES-SCLC. Let’s check out the swells coming in: A few comments here as well.

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. link] [19] FDA prescribing information for zilucoplan.

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The Pharma Data

JANUARY 7, 2021

The Company is currently seeking FDA approval of voclosporin for the potential treatment of lupus nephritis (LN). The Company’s head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland.

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

While treating rare diseases presents significant challenges due to small patient populations and limited financial incentives, the Orphan Products Grants Program provides crucial financial support to help bridge the gap between early research and successful treatment development. Relative to other areas of medicine (e.g.,

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The Pharma Data

JUNE 25, 2025

Designed using the same fundamental mechanism as Biogen’s approved SMA treatment SPINRAZA (nusinersen), salanersen represents a next-generation approach aimed at greater potency and less frequent dosing—potentially requiring only once-yearly administration.

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The Pharma Data

OCTOBER 21, 2020

a biopharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced today it received approval from the U.S. Food and Drug Administration (FDA) to market Ephedrine Sulfate Injection in a ready-to-use 50mg/10 ml single use vial presentation. BRIDGEWATER, N.J., and Canada.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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The Pharma Data

JUNE 15, 2025

The new results were presented in a late-breaking oral presentation (Abstract #LB4001) at the 2025 European Hematology Association (EHA) Congress. According to the data, the combination demonstrated a high ORR and a strong depth of response in a patient population with limited treatment options and poor outcomes under standard care.

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Drug Target Review

JUNE 5, 2025

Currently, three FDA-approved disease-modifying drug therapies are available: hydroxyurea, crizanlizumab and L-glutamine, though each has limitations that affect patient compliance. The use of FDA-approved medications for preventing vaso-occlusive events in sickle cell disease. JAMA Netw Open. 2023 Nov 1;6(11):e2344546.

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Drug Target Review

JANUARY 8, 2024

Jerry has over 30 years of experience in the biopharmaceutical industry and has been involved in the discovery, clinical development, and global commercialisation of more than a dozen FDA-approved drugs with multiple successful exits. What’s next for Life Bioscience’s preclinical studies?

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The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

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The Pharma Data

SEPTEMBER 8, 2021

today announced that data from its migraine portfolio will be presented at the International Headache Congress 2021, held jointly this year by the International Headache Society and the European Headache Federation, from September 8-12. The company will share a total of 23 abstracts, including two oral presentations and one abstract lecture.

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The Pharma Data

OCTOBER 15, 2020

The findings were presented at TCT Connect , the 32nd annual scientific symposium of the Cardiovascular Research Foundation. In the first study, presented by Hemindermeet Singh, MD, of Ascension St. This press release features multimedia. View the full release here: [link]. Figure 1 (Graphic: Business Wire). The Impella 2.5,

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The Pharma Data

JULY 8, 2021

Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

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New Drug Approvals

APRIL 25, 2025

3] Inavolisib was approved for medical use in the United States in October 2024. [3] The difluoromethyl group can interact with the hydroxyl group presented on Ser774 (conserved) in p110, which is 3.2 3] [6] [20] [21] The drug application was granted priority review and breakthrough therapy designations by the FDA. [3]

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New Drug Approvals

APRIL 18, 2025

2] Crinecerfont was approved for medical use in the United States in December 2024. [2] 2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 2] The FDA granted the approval of Crenessity to Neurocrine Biosciences, Inc. [2] Food and Drug Administration (FDA) (Press release).

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The Pharma Data

JULY 21, 2021

– Allergan, an AbbVie (NYSE: ABBV) company, today announced that it will present new data from its leading portfolio of eye care medicines at the 2021 ASCRS (American Society for Cataract and Refractive Surgery) Annual Meeting being held July 23-27 in Las Vegas, NV. Details about Allergan’s presentations are as follows: .

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The Pharma Data

APRIL 11, 2023

NYSE and TASE: TEVA),today announced six poster abstracts across its neurology portfolio will be presented at the American Academy of Neurology (AAN) Annual Meeting on April 22-27, 2023. Additional abstracts from the Enroll-HD Global Registry and AJOVY ® (fremanezumab-vfrm) will also be presented.

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The Premier Consulting Blog

JANUARY 14, 2025

These resources provide accurate and current strategies that strongly represent FDAs standpoint and have routinely been leveraged by Premiers team of strategists when guiding sponsors through their development plans. The summary presented in the table below features some of these initiatives. Program What is it?

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Broad Institute

JULY 19, 2023

They identified hundreds of capsids that bound to LY6A or LY6C1 and delivered their cargo to the central nervous system in mice more efficiently than AAV9, a capsid that crosses the blood-brain barrier and is used in an FDA-approved gene therapy, but is inefficient at delivering to the brain.

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FDA Law Blog: Biosimilars

NOVEMBER 5, 2023

This prestigious four-day conference promises to deliver a wealth of cutting-edge insights, featuring presentations by eminent scientists and clinicians, all unified under the thought-provoking theme, “Towards Better Speech Perception and Beyond.” The comprehensive agenda for the symposium can be accessed in its entirety here.

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Pharmaceutical Development Group

JANUARY 7, 2022

Effective and consistent use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting , NDA Consulting, BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA Approval. Spanogle, Ph.D.

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Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding.

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