New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] “FDA Approves New Drug for Ulcerative Colitis” Medscape.

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The Premier Consulting Blog

APRIL 15, 2024

Even for repurposed drugs being developed under the 505(b)(2) New Drug Application (NDA) pathway, it is critical to review the existing nonclinical and clinical data on the drug to determine what nonclinical studies may be beneficial to conduct prior to the PIND meeting and include this information in the package.

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The Pharma Data

APRIL 4, 2023

As part of the comprehensive submission package to the European Marketing Authorization, Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing its approved adalimumab 50 mg/mL 2 with the 100 mg/mL (HCF). The adalimumab reference medicine (Humira ® *) was first approved with an adalimumab concentration of 50 mg/mL.

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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.

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The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. by Janssen Pharmaceuticals, Inc. Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. UNIVERSE was conducted in two parts.

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New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 Landiolol was approved for medical use in Japan in 2002, [10] [11] in Canada in November 2023, [1] and in the United States in November 2024. [12] Food and Drug Administration (FDA).

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DrugBank

FEBRUARY 12, 2025

The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drug development. This approach capitalizes on prior investments in R&D, mitigates risk by leveraging established safety and pharmacokinetic profiles, and accelerates the delivery of treatments to patients.

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The Pharma Data

NOVEMBER 26, 2020

Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Galactosidase-A enzyme.

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The Pharma Data

DECEMBER 29, 2020

Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Galactosidase-A enzyme.

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The Pharma Data

DECEMBER 15, 2020

The Phase I/IIa clinical trial is a randomized, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in 79 male and female healthy subjects and patients with myasthenia gravis. The secondary outcome involves pharmacokinetic endpoints.

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The Pharma Data

DECEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. About Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. View original content: [link].

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The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Hepatic Impairment: EDURANT ® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT ® have not been evaluated in these patients.

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Drug Target Review

JUNE 5, 2023

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.

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The Pharma Data

SEPTEMBER 1, 2021

Approval is backed by nearly two decades of proven efficacy and safety of Janssen’s long-acting injectable portfolio of schizophrenia medicines. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. 1 Study evaluations included efficacy, safety, pharmacokinetics, and pharmacodynamics.

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The Pharma Data

APRIL 27, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that that the U.S. The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). About Takeda Pharmaceutical Company Limited. Lauren Padovan.

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The Pharma Data

MARCH 16, 2021

TREMFYA q4w is not currently FDA-approved. Efficacy, safety, pharmacokinetic, immunogenicity and biomarker evaluations were performed in the study on a defined schedule. The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®. About Psoriatic Arthritis.

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The Pharma Data

FEBRUARY 25, 2021

The FDA approved Evrysdi in August 2020 as the first and only at home SMA treatment with proven efficacy in adults, children and infants 2 months and older. Food and Drug Administration (FDA) approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older. mg/kg for Part 2.

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The Pharma Data

SEPTEMBER 27, 2020

In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older. The FDA approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older. 59% of infants were able to sit without support for at least 5 seconds. No new safety signals were identified.

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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. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.

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The Pharma Data

MAY 4, 2021

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. It is approved in the U.S. Olumiant was recently approved in Japan for the treatment of pneumonia associated with COVID-19 in hospitalized adult patients.

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New Drug Approvals

MAY 14, 2025

5] Rezafungin was approved for medical use in the United States in March 2023, [1] [6] [5] and in the European Union in December 2023. [2] 7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis. [8] 2] [3] CAS No. 23 March 2023. 64 (1): 2752.

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New Drug Approvals

APRIL 21, 2025

SNDX-50613 free base SNDX-5613 free base SNDX50613 free base SNDX5613 free base FDA APPROVED 11/15/2024, Revuforj , To treat relapsed or refractory acute leukemia N -ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro- Food and Drug Administration (FDA) (Press release).

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New Drug Approvals

APRIL 27, 2025

9] [10] [11] Pharmacokinetics After oral administration, less than 10% of the dose is absorbed. 13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15] 13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15]

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New Drug Approvals

MAY 30, 2025

PATENT [link] PATENT CN112457267 [link] REF Satish Kumar RangarajuSatish Kumar Rangaraju The first FDA-approved treatment for Demodex Blepharitis, a common eyelid disease caused by microscopic mites living in the eyelashes’ hair follicles. Retrieved 5 August 2023. ^ “Xdemvy: FDA-Approved Drugs” U.S.

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New Drug Approvals

APRIL 2, 2025

. ^ Jump up to: a b c [link] ^ “Alpha Cognition’s Oral Therapy Zunveyl Receives FDA Approval to Treat Alzheimer’s Disease” (Press release). “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88” WHO Drug Information. Alpha Cognition. 29 July 2024.

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New Drug Approvals

MAY 11, 2025

5] Omaveloxolone was approved for medical use in the United States in February 2023, [2] [5] [6] [7] [8] and in the European Union in February 2024. [3] 3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] Food and Drug Administration (FDA). 2] [5] It is taken by mouth. [2]

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Drug Target Review

APRIL 25, 2025

Addressing the gaps associated with liver-on-chips, a recent 3D hepatic spheroid study predicted DILI liabilities of 152 FDA-approved small molecules using a high-throughput 384 well plate-based system with a sensitivity of 72 percent and specificity of 89 percent. Organs-on-chips: a decade of innovation.

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New Drug Approvals

APRIL 5, 2025

Retrieved 2 January 2023. ^ “Trecondi (Link Medical Products Pty Ltd T/A Link Pharmaceuticals)” Therapeutic Goods Administration (TGA). Jump up to: a b “FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS” U.S. 21 December 2022.

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The Pharma Data

SEPTEMBER 1, 2020

Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020. FDA-APPROVED INDICATION FOR ZEPOSIA.

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New Drug Approvals

APRIL 21, 2025

under reduced pressure to afford a solid residue of Formula IX.Example 7Preparation of a Pharmaceutically Acceptable Salt of Formula I The solid residue of Formula IX was dissolved in water (57 mL) and stirred for 10 min and cooled to 05 C. Jump up to: a b “Novel Drug Approvals for 2024” U.S. 61 (17): 78627876. PMC 6276790.

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Codon

FEBRUARY 23, 2025

In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months.

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