Search Results for “FDA” – Page 32 – media

FDA signs off on new uses for Astellas and Pfizer’s Xtandi, Merck’s Keytruda

The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expansion is in stomach cancer, allowing its use alongside chemotherapy to treat first-line patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer. It now becomes the only androgen receptor inhibitor approved by the FDA for patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). These patients can be treated with Xtandi with or without GnRH analog therapy. Of men who have had prostate cancer treatment, 20% to 40% will have BCR within 10 years. Of those with high-risk BCR, 90% will develop metastatic disease, with one in three dying. The nod was backed up by the phase 3 EMBARK ...
- Source: drugdu
- 117
- November 21, 2023
AstraZeneca Cancer Drug Is First in Class, But FDA Nod Is Narrower Than Expected

The most common type of breast cancer now has a new targeted treatment: an AstraZeneca drug that’s first in a new class of therapies addressing a certain genetic signature. But the new approval is narrower than expected, which limits the total addressable market for the therapy. The FDA approved the new drug, capivastertib, for use in combination with fulvestrant, an older AstraZeneca breast cancer therapy. The new drug will be marketed under the brand name Truqap. Approval of Truqap covers the treatment of adults with advanced cases of breast cancer classified as HR positive and HER2 negative. Those patients must also have disease that has either progressed after treatment with a hormone therapy or has come back after adjuvant therapy. Truqap joins a group of therapies already available for HR positive, HER2 negative breast cancer, including products from AstraZeneca. Truqap stands apart from them as the first AKT inhibitor. AKT ...
- Source: drugdu
- 117
- November 20, 2023
FDA approves study of Versameb’s mRNA therapy in urinary incontinence

Swiss company Versameb will initiate a clinical trial investigating a messenger ribonucleic acid (mRNA) to treat stress urinary incontinence, after receiving clearance from the US Food and Drug Administration (FDA). The FDA approved the company’s investigational new drug (IND) application for a Phase IIa trial of VMB-100 – an intramuscularly locally delivered, sequence-engineered mRNA. The study is scheduled to start in the first half of 2024. Versameb’s candidate encodes human insulin-like growth factor-1 (IGF-1). According to Versameb, preclinical studies have shown that VMB-100 can induce the expression of IGF-1 in human muscle cells, and the candidate accelerated the regeneration of the urinary sphincter muscle and restored urinary sphincter function in animal models of stress urinary incontinence, after a single dose of treatment. Stress urinary incontinence is a condition where there is an involuntary leakage of urine due to a weakened urinary sphincter muscle. It is a condition that particularly affects ...
- Source: drugdu
- 174
- November 20, 2023
LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test

Dive Brief The Food and Drug Administration has authorized the first chlamydia and gonorrhea test with at-home sample collection. LetsGetChecked received de novo authorization for the Simple 2 Test, an over-the-counter kit that uses vaginal swabs or urine specimens to detect the bacteria that cause the two sexually transmitted diseases (STDs). The authorization will move sample collection from the doctor’s office to the home — potentially increasing testing of STDs, which are on the rise — and create a 510(k) pathway for rival diagnostics. Dive Insight Until this week, the FDA had only authorized at-home sample collection for one STD, HIV. Sample collection for all other STDs occurred at the point of care, for example, in a doctor’s office. People may be less likely to get tested at the point of care, particularly for frequently asymptomatic infections such as chlamydia and gonorrhea, because of concerns about confidentiality and convenience. The ...
- Source: drugdu
- 136
- November 18, 2023
FDA Approves Bristol Myers Squibb’s Augtyro for Non-Small Cell Lung Cancer

Pharmaceutical Executive Editorial Staff Repotrectinib (Augtyro) is a next-generation, potential best-in-class tyrosine kinase inhibitor approved to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer. The FDA has approved Bristol Myers Squibb’s repotrectinib (Augtyro) to treat locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).1 Repotrectinib is a next-generation, potential best-in-class tyrosine kinase inhibitor (TKI) that targets ROS1- or NTRK-positive locally advanced or metastatic solid tumors. The drug was designed to improve the durability of response and with favorable properties that improve intracranial activity. “While progress has been made in the treatment of NSCLC over the past decade, there is still a need to address this particularly difficult-to-treat form of the disease with innovative science and a targeted approach,” Samit Hirawat, MD, executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb, said in a press release.1 “As the only approved next-generation TKI for ROS1 positive ...
- Source: drugdu
- 183
- November 18, 2023
CorMedix Wins FDA Approval for Antimicrobial Drug Combo After Two Rejections

By Tristan Manalac The FDA on Wednesday approved CorMedix’s DefenCath (taurolidine and heparin) to reduce catheter-related blood stream infections in adults with kidney failure who are on chronic hemodialysis through a central venous catheter. DefenCath is the first FDA-approved antimicrobial catheter lock solution in the U.S., according to CorMedix’s announcement. CorMedix expects DefenCath to be available in the inpatient setting in the first quarter of 2024. The company’s stock was trading 35% higher Wednesday morning in response to the approval, according to Seeking Alpha. CorMedix CEO Joseph Todisco in a statement said that DefenCath’s approval was a “major advancement” for preventing life-threatening infections and provides doctors “an option to reduce the risk of infections in a patient population already vulnerable due to underlying kidney failure.” DefenCath is a combination of the amino acid derivative taurolidine and the anticoagulant heparin. Taurolidine has demonstrated strong antimicrobial activity against gram-positive and gram-negative bacteria, ...
- Source: drugdu
- 187
- November 18, 2023
BMS Drug Augtyro Gets FDA Approval to Treat ROS1-Positive NSCLC

By Tyler Patchen The FDA has approved Bristol Myers Squibb’s tyrosine kinase inhibitor Augtyro (repotrectinib) to treat patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer, augmenting the company’s arsenal of cancer and NSCLC treatments. According to BMS’s Wednesday announcement, the drug is meant to “minimize interaction” that can lead to certain forms of treatment resistance in ROS1-positive NSCLC patients. The FDA approved the drug based on the TRIDENT-1 study evaluating Augtyro in TKI-naïve and TKI-penetrated patients. Results showed that for TKI-naïve individuals, the objective response rate (ORR) was 79%, with a median duration of response of 34.1 months. For patients that were TKI-penetrated and had no chemotherapy, the ORR was 38%, with a median duration of response of 14.8 months. “New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” Jessica J. Lin, the ...
- Source: drugdu
- 188
- November 18, 2023
Takeda’s enzyme replacement therapy approved by FDA for rare blood clotting disorder

Takeda’s Adzynma (ADAMTS13, recombinant-krhn) has been approved by the US Food and Drug Administration (FDA) as the first therapeutic option for congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare inherited blood clotting disorder. Estimated to affect fewer than 1,000 people in the US, cTTP is caused by a deficiency in the ADAMTS13 enzyme that regulates blood clotting. Patients with cTTP can experience severe bleeding episodes, strokes and damage to vital organs, and mortality rates are high if left untreated. “Without treatment, cTTP is ultimately fatal,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. He continued: “[The] approval reflects important progress in the development of much-needed treatment options for patients affected by this life-threatening disorder.” Until now, cTTP treatment has typically involved plasma therapy, which Takeda has previously described as “insufficient in restoring ADAMTS13, time-consuming and costly”. Adzynma, which has been authorised for use as a preventative ...
- Source: drugdu
- 98
- November 16, 2023
FDA deems stolen Medtronic scopes problem a Class I recall

BY SEAN WHOOLEY Conforming devices can be identified by their serial number. The FDA today issued a notice saying the recall of Medtronic (NYSE: MDT)+ McGrath Mac video laryngoscopes is Class I, the most serious kind. Medtronic in October warned on stolen, defective McGrath Mac video laryngoscopes offered for sale by unauthorized third parties. The company initiated a recall as a result of the stolen, defective products. The company informed the public of the illegal offering of the devices by third parties through various social media platforms. Affected products failed to pass Medtronic’s rigorous tests established for the product. The company did not release them for sale, distribution or importation. Potential adverse effects from defective scopes include hypoxia, hypercapnia, tissue damage/trauma and/or a delay to treatment. More details on the Medtronic recall The recall affects 5,709 devices in the U.S., distributed between July 5, 2019, and July 14, 2022. Medtronic’s ...
- Source: drugdu
- 98
- November 15, 2023
Acon receives first FDA clearance for over-the-counter COVID-19 antigen test

Dive Brief The Food and Drug Administration has cleared the first over-the-counter COVID-19 antigen test via a traditional premarket review pathway. Acon Laboratories secured the 510(k) clearance for its Flowflex COVID-19 Antigen Home Test. The firm received emergency use authorization (EUA) in 2021 and, by following in the footsteps of Cue Health’s de novo molecular test, converted that approval into a conventional clearance. The clearance gives Americans another fully authorized test ahead of an infectious respiratory disease season in which testing volumes are forecast to be down compared to prior years. Dive Insight The EUA program enabled the FDA to quickly make COVID-19 tests available in the U.S. during the public health emergency. Today, the administration maintains EUAs on 65 antigen tests and 276 molecular diagnostic tests for COVID-19. While the EUAs remain in effect, the FDA is encouraging manufacturers to transition to its normal pathways now that the acute ...
- Source: drugdu
- 99
- November 14, 2023

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