Search Results for “FDA” – Page 9 – media

Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease

Iqirvo failed as a treatment for the fatty liver disease MASH, but the drug is now FDA approved in primary biliary cholangitis. An Intercept Pharmaceuticals drug already treats this rare liver disease and Gilead Sciences is poised to compete with its PBC drug approaching an FDA decision this summer. By Frank VinluanA rare liver disease that can progress to organ failure now has a new FDA-approved therapy, a drug from Ipsen that brings a novel approach to treating the chronic condition. The Ipsen drug, elafibranor, treats primary biliary cholangitis (PBC). The regulatory decision announced late Monday makes the drug just the third approved therapy for the chronic liver disorder, but competition in this indication is heating up. Paris-based Ipsen will market its new product under the brand name Iqirvo. PBC is an autoimmune condition in which bile and toxins build up in the liver, leading to inflammation and damage to ...
- Source: drugdu
- 139
- June 13, 2024
【EXPERT Q&A】What is FDA certification, and why is it necessary?

Drugdu.com expert’s response: FDA certification refers to the process in which the Food and Drug Administration of the United States reviews a product and recognizes that the product meets its qualification requirements. This certification is based on rigorous scientific evaluation and regulatory review to ensure that the safety, effectiveness, and quality of the product meet standards. The importance and reasons of FDA certification： 1.Ensuring product safety: FDA certification requires products to meet strict safety and effectiveness standards to ensure that consumers are purchasing safe and reliable products that do not pose a risk to human health. 2.Promote public trust: FDA certification is an important recognition of product quality and safety by the public, which can improve consumer trust and recognition of products and increase market competitiveness. 3.Encourage enterprises to operate in compliance with regulations: By obtaining FDA certification, enterprises need to strictly comply with relevant regulations and quality standards, which ...
- Source: drugdu
- 140
- June 12, 2024
FDA Approves GSK’s Arexvy to Prevent Respiratory Syncytial Virus in Adults Aged 50-59 with Increased Risk

Don Tracy, Associate Editor Arexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease. GSK’s Arexvy (RSV Vaccine, Adjuvanted) has been approved by the FDA for an expanded indication to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in adults aged 50-59 years with an increased risk. The approval for this age group was based on encouraging results from a Phase III trial (NCT05590403) that evaluated the immune response and safety of Arexvy in adults aged 50-59, including those with underlying medical conditions. Arexvy was previously approved for adults aged 60 years and older for the same purpose in May 2023. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommended its use through shared clinical decision-making.1 “[This] approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. For those ...
- Source: drugdu
- 104
- June 12, 2024
FDA Committee Votes Against Approval of Lykos Therapeutics’ MDMA Treatment for PTSD

Don Tracy, Associate Editor In a majority vote, the Psychopharmacologic Drugs Advisory Committee cited concerns regarding the data presented for MDMA as a treatment for post-traumatic stress disorder. The FDA’s Psychopharmacologic Drug Advisory Committee (PDAC) has voted against recommending Lykos Therapeutics’ New Drug Application (NDA) for midomafetamine (MDMA) capsules for use in combination with psychological intervention for the treatment of post-traumatic stress disorder (PTSD) in adults. The committee voted 2-to-9 against the efficacy of the treatment, and voted 1-to-10 against the benefits outweighing the risks, stating its doubts that MDMA-assisted therapy is effective in treating PTSD.1 “We are disappointed in today’s vote given the urgent unmet need in PTSD and appreciate that the committee faced a challenging and atypical assignment, which was to evaluate a therapeutic approach that combines drug therapy (MDMA) and psychological intervention,” said Amy Emerson, CEO, Lykos Therapeutics, in a press release. As a basis of their ...
- Source: drugdu
- 78
- June 11, 2024
Astellas Confirms FDA Acknowledgement of Zolbetuximab Resubmission

Mike Hollan The drug had previously been submitted, but required resubmission due to production issues. FDA acknowledged that Astellas has resubmitted zolbetuximab for a Biologics License Application (BLA).1 The drug is a first-in-class claudin 18.2-targets monoclonal antibody and is designed to treat various forms of gastric cancer. According to a press release issued by Astellas, FDA has set November 9, 2024, as its new target action date. The drug had been previously submitted, but had to be resubmitted after Astellas received a complete response letter from FDA in January, 2024. While the agency did not state any issues with the clinical data, efficacy, or safety of the drug, it required resubmission due to third-party manufacturing deficiencies. Astellas resubmitted the drug on May 9, 2024, but only just announced confirmation from FDA. In a press release, Astellas’ senior vice president and head of immuno-oncology development Moitreyee Chatterjee-Kishore, PhD, MBA, said, “Astellas ...
- Source: drugdu
- 121
- June 7, 2024
FDA fast tracks Quince Therapeutics’ rare ataxia drug EryDex

California-based biotech Quince Therapeutics has won fast track designation from the US Food and Drug Administration (FDA) for its ataxia-telangiectasia (A-T) drug EryDex. According to the 3 June announcement, fast track designation was awarded to address a high unmet medical need for patients with A-T. The status allows for earlier interactions with the FDA as Quince seeks accelerated approval, and also the possibility to undergo rolling reviews. A-T is a rare disease of the nervous and immune systems, affecting motor movement and speech. EryDex utilises autologous intracellular drug encapsulation (AIDE) technology to administer dexamethasone sodium phosphate (DSP) into a patient’s red blood cells. Red blood cells filled with DSP are then reinfused into the patient, allowing for the slow release of steroids over several weeks, without the long-term toxicity commonly associated with chronic administration. The FDA lifted a partial clinical hold that was on the drug in October 2023, advancing ...
- Source: drugdu
- 73
- June 6, 2024
FDA Grants Priority Review to Jazz Pharmaceuticals’ Zanidatamab for Multiple Forms of HER-2 Positive Biliary Tract Cancer

Don Tracy, Associate Editor Submission for the FDA approval of zanidatamab was based on promising data from the Phase IIb HERIZON-BTC-01 clinical trial in patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer. Jazz Pharmaceuticals announced that the FDA has granted Priority Review to zanidatamab, a bispecific antibody being evaluated for previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC). According to the company, the submission was based on positive results from Cohort 1 of the Phase IIb HERIZON-BTC-01 clinical trial, which showed a confirmed objective response rate (cORR) of 41.3%. The FDA assigned the application with a Prescription Drug User Fee Act target action date of November 29, 2024. A Phase III trial, HERIZON-BTC-302, is evaluating zanidatamab in combination with standard-of-care therapy against standard-of-care therapy alone in first-line advanced or metastatic HER2-positive BTC.1 “The priority review designation for zanidatamab underscores the critical ...
- Source: drugdu
- 108
- June 3, 2024
FDA Approves Breyanzi for Relapsed or Refractory Mantle Cell Lymphoma

Davy James Breyanzi, a CD19-directed CAR T-cell therapy, granted fourth FDA approval to treat a distinct subtype of non-Hodgkin lymphoma.The FDA has approved Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL) who were previously administered at least two lines of systemic therapy that included a Bruton tyrosine kinase (BTK) inhibitor.1 The regulatory action marks the fourth indication for Breyanzi to treat a distinct subtype of non-Hodgkin lymphoma. “With Breyanzi, we are delivering on the promise of cell therapy by offering a definitive treatment option for some of the most difficult-to-treat lymphomas,” Bryan Campbell, senior vice president, head of Commercial, Cell Therapy, BMS, said in a press release. “We are proud of the advances we are making to bring our differentiated CAR T cell therapy to the most patients across indications and lines of therapy to ensure treatment options that ...
- Source: drugdu
- 95
- June 3, 2024
FDA Grants Priority Review to Keytruda Combination as a First-Line Treatment for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

Don Tracy, Associate Editor Priority review designation for Keytruda is based on promising results from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated improved overall survival in patients with unresectable advanced or metastatic malignant pleural mesothelioma. Merck has announced that the FDA granted Priority Review designation to its application for Keytruda (pembrolizumab) plus chemotherapy as a first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma. According to the company, the application was a based on positive data from the Phase II/III IND.227/KEYNOTE-483 trial, which found that Keytruda in combination with chemotherapy significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to chemotherapy alone. Further, death was reduced by 21% (HR=0.79 [95% CI, 0.64-0.98]; two-sided p value=0.0324), with a median OS of 17.3 months (95% CI, 14.4-21.3) versus 16.1 months (95% CI, 13.1-18.2) for chemotherapy alone. After a year of treatment, the estimated PFS ...
- Source: drugdu
- 142
- June 1, 2024
FDA grants priority review to Genentech’s Inavolisib

Genentech, a member of the Roche Group, announced that the USFDA has accepted the company’s new drug application and granted priority review to inavolisib, an investigational oral therapy, in combination with palbociclib (Ibrance) and fulvestrant. The inavolisib-based regimen was evaluated in adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. The priority review is based on the positive Phase III INAVO120 results, which showed the inavolisib-based regimen more than doubled progression-free survival, reducing the risk of disease worsening or death by 57 per cent compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95 per cent CI: 0.32-0.59, p<0.0001) in the first-line setting. Overall survival (OS) data were immature at the time of primary analysis, but a clear positive trend was observed ...
- Source: drugdu
- 86
- May 31, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.