New Drug Approvals

JULY 25, 2025

Vamorolone , sold under the brand name Agamree , is a synthetic corticosteroid , which is used for the treatment of Duchenne muscular dystrophy. [4] In December 2023, it was approved in the EU for the treatment of patients ≥4 years of age. Treatment of crude 9.3 4] [5] [6] [7] [8] It is taken by mouth. [1] with peracetic acid 9.4

FDA

The Pharma Data

AUGUST 1, 2025

Food and Drug Administration (FDA). The approval authorizes AUCATZYL® for the treatment of adult patients aged 26 and older diagnosed with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) in all 27 European Union member states. Source Link

Therapies

New Drug Approvals

APRIL 25, 2025

12] However, absorption, metabolism, and excretion data of taselisib , a molecule with a related chemical scaffold, suggest moderately slow absorption into the systemic circulation, metabolism to play a minor role in drug clearance, and biliary excretion to be the main route of excretion. [13] Hz, 1H), 6.41 (dd, J=8.8, Hz, 1H), 5.02-4.89

FDA

New Drug Approvals

MAY 9, 2025

Randomization was stratified based on whether the ESR1 mutation was detected or not, prior treatment with fulvestrant, and presence of visceral metastasis. [2] Randomization was stratified based on whether the ESR1 mutation was detected or not, prior treatment with fulvestrant, and presence of visceral metastasis. [2] 8 February 2023.

FDA

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Regulatory agencies, such as the U.S.

Drug Development

SugarCone Biotech

MARCH 24, 2025

Consequently, these drugs have limited ability to keep patients disease-free and limited impact on patient survival. Other mechanisms that cancer cells use to escape from TCE treatment are less expected. This provides ample flexibility to optimize the treatment modality to attack specific cancers. doi: 10.1073/pnas.1716266115

Immune Response

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. Retrieved 15 August 2024. ^ “Regulatory Decision Summary for Zilbrysq” Drug and Health Products Portal.

FDA

Drug Target Review

JULY 29, 2025

Effective financial management is a cornerstone in the success of clinical trials, which are integral to the advancement of drug discovery. This led her to found Condor Software in 2020, a company focused on providing cloud-based solutions that integrate financial operations with clinical trials.

Clinical Trials

New Drug Approvals

JUNE 29, 2025

2020/0062765) was dissolved in ethanol (604 mL) at 50℃. Medical uses Taletrectinib is indicated for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer. [1] Food and Drug Administration. 1] [2] It is used as the salt, taletrectinib adipate. [1] 1] It is taken by mouth. [1]

International

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. As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers. million people every year.

Vaccine

The Pharma Data

JULY 3, 2025

(NASDAQ: SBFM), a pharmaceutical company focused on developing and commercializing life-saving medicines across oncology, antiviral therapies, and other therapeutic areas, has announced the commercial launch of its first biosimilar drug, NIOPEG® , in Canada. The global market for NEULASTA® and its biosimilars is substantial.

Marketing

Codon

JUNE 5, 2025

.” Four years earlier, in 2019, Gray had become the first patient with sickle cell anemia — a genetic disorder that causes red blood cells to become sticky and rigid — to receive an experimental treatment using CRISPR genome editing. Therapeutics The first Cas13-based clinical trial was approved in 2024.

DNA

BioPharma Drive: Drug Pricing

JUNE 11, 2025

SciePro via Getty Images Dive Brief: The Food and Drug Administration has approved a new oral medication for an uncommon kind of tumor, clearing Nuvation Bio’s Ibtrozi on Wednesday for certain people whose metastatic non-small cell lung cancer has a type of alteration in the gene ROS1. though the drug’s commercial prospects are unclear.

FDA

New Drug Approvals

APRIL 18, 2025

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] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] Monoisotopic: 482.1594906 Chemical FormulaC 27 H 28 ClFN 2 OS CAS No.

FDA

New Drug Approvals

JULY 8, 2025

1428321-10-1 Pritelivir mesylate is an antiviral drug currently under development, specifically targeting herpes simplex virus types 1 and 2 (HSV-1 and HSV-2). It is being investigated as a potential treatment for various herpes infections, including those resistant to traditional antivirals like acyclovir.

Virus

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. Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent.

FDA

Drug Patent Watch

JANUARY 13, 2025

As we delve into the intricate world of biosimilar market dynamics, we’ll explore how these complex molecules are reshaping treatment paradigms across diverse patient populations. from 2020 to 2025[1]. from 2020 to 2025[1]. .”[1] from 2020 to 2025[1]. billion by 2025, growing at a CAGR of 34.2%

Biosimilars

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. The common belief that SSPs encourage more drug use is contradicted by the data.

Drugs

Codon

NOVEMBER 1, 2024

Amodei also imagines the ways AI could accelerate biological research and yield miraculous cures in the 21st century; everything from the prevention and treatment of nearly all infectious and inherited diseases to the elimination of most cancers. growing drugs in 1,000-liter bioreactors), regulatory limits, and ethical quandaries.

DNA

BioPharma Drive: Drug Pricing

JULY 18, 2025

Food and Drug Administration headquarters in Silver Spring, Md., Alamy The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive. You can unsubscribe at anytime.

Therapies

Codon

AUGUST 4, 2025

Today, it is used in everything from chemical analysis to drug discovery, but it was not initially developed with biologists in mind. The organization traces its origins back to 2020, when Adam Marblestone , CEO of Convergent Research, first approached Nikolai Slavov.

Laboratories

BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

Clinical Trials

New Drug Approvals

AUGUST 4, 2025

Donafenib , sold under the brand name Zepsun , is a pharmaceutical drug for the treatment of cancer. In China, donafenib is approved for the treatment of unresectable hepatocellular carcinoma in patients who have not previously received systemic treatment. [1] SYN Di Martino et al. link] Syn Donafenib (Zepsun).

Metabolic Stability

Drug Patent Watch

JANUARY 7, 2025

Generic drugs play a crucial role in providing affordable medication options to patients. As healthcare professionals, it’s our responsibility to educate patients about generic drugs and empower them to make informed decisions about their treatment options. What Are Generic Drugs?

Drugs

National Institute on Drug Abuse: Nora's Blog

JUNE 12, 2025

1 The drug crisis in America has demanded a sustained focus to extinguish those fires by expanding treatment access and overdose prevention and reversal strategies—and encouragingly, data show that overdose fatalities have been declining since 2023.

Research

New Drug Approvals

JULY 28, 2025

Chiglitazar (trade name Bilessglu ) is a drug for the treatment of type 2 diabetes. [1] Chiglitazar (17), a novel nonthiazolidinedione pan-agonist of α, δ, and γ peroxisome proliferator-activated receptors (PPARs), has shown promise for the treatment of type 2 diabetes. Drugs 2022, 82, 87− 92. Patent US 10640465 B2, 2020.

Trials

New Drug Approvals

JULY 18, 2025

D-ARABINOFURANOSYL)- 4′-C-Azido-2′-deoxy-2′-fluoro-b-D-arabinocytidine Azvudine is an antiviral drug which acts as a reverse transcriptase inhibitor. [3] It was approved in China in 2021 as a first-in-class treatment for human immunodeficiency virus (HIV). 2020, 63, 8554−8566. (7) Example 9 Weigh 4.82

RNA

New Drug Approvals

JULY 28, 2025

ALPHA.S)- Dorzagliatin(18)was developed by Hua Medicine as a treatment for diabetic kidney disease(DKD), type1diabetes mellitus(T1DM), and type2 diabetes mellitus (T2DM). 1] Unlike other diabetes drugs, it is intended to increase insulin sensitivity. [2] Drugs 2022, 82, 1745−1750. Drugs 2020, 80, 467−475.

Small Molecule

National Drug & Alcohol Research Centre Blog

DECEMBER 4, 2023

Kendal Chidwick NDARC’s Kendal Chidwick discusses the findings from a recently published study that examined how patterns of opioid agonist treatment medicines have changed over the past decade. Other changes around this time aimed at improving treatment accessibility included increased use of take-home doses and telehealth appointments.

Treatment

Drug Target Review

JULY 4, 2023

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

Small Molecule

Eye on FDA

FEBRUARY 10, 2021

Looking now to a review of enforcement by the Office of Prescription Drug Promotion (OPDP) in 2020, we see a different picture. The collection of letters issued by OPDP during 2020 can be found here. The Violations – In recent years, there has been an uptick of activity aimed at the promotion of an unapproved drugs.

FDA

SCIENMAG: Medicine & Health

JULY 5, 2023

New drugs are often used not only for one disease (first approved indication) but also for other diseases (supplemental indications).

Treatment

Drug Hunter

AUGUST 21, 2023

Obtaining adequate drug exposure in the brain is key to treating CNS diseases effectively. Recently, Dennis Koester gave us a crash course in CNS drug discovery in a Drug Hunter Flash Talk. Why Kp,uu is the Most Important Parameter in CNS Drug Discovery What Influences the Kp,uu of Drugs?

Drugs

Drug Target Review

SEPTEMBER 21, 2023

The findings supported the possibility put forward by Cotton et al (2016) concerning the chance of repurposing these drugs for adulticidal treatment. The available treatment for that is minor surgery -to remove the nodules. Need for adulticidal drugs More than 99 percent of countries worldwide has been affected by this disease.

Drugs

National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

Treatment

The Pharma Data

NOVEMBER 1, 2020

Vancouver-based Algernon Pharmaceuticals plans to conduct a late-stage study to evaluate an orally delivered drug, NP-120 (ifenprodil), as a COVID-19 treatment. The drug was originally developed in the 1990s by Sanofi to treat peripheral circulatory disorders and it is still used in generic form in Japan. Source link.

Pharmaceuticals

Broad Institute

JUNE 14, 2024

Some CRISPR screens may be missing cancer drug targets By Allessandra DiCorato June 14, 2024 Breadcrumb Home Some CRISPR screens may be missing cancer drug targets Current CRISPR guides don’t work equally well in cells from people of all ancestries, which could lead to false negative results.

Drugs