Search Results for “FDA” – Page 17 – media

FDA Fast Tracks ImmVira’s Oncolytic Herpes Simplex Virus Therapy for Head and Neck Squamous Cell Cancer

Davy James MVR-T3011 IT is in development to treat patients with recurrent or metastatic head and neck squamous cell cancer whose disease progressed following platinum-based chemotherapy and at least one prior line of a PD-1/PD-L1 therapy. ImmVira’s oncolytic herpes simplex virus (oHSV) therapy MVR-T3011 IT for intratumoral injection has been granted Fast Track designation by the FDA to treat patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC) whose disease progressed following platinum-based chemotherapy and at least one prior line of an anti–programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy.1 The novel oHSV treatment is a genetically engineered virus developed to produce replication potency in tumor cells as well as highly restricted replication in normal cells. The ability of MVR-T3011 to boost the immune response within the tumor microenvironment is increased by adding a PD-1 antibody and IL-12 into the construct, according to ImmVira. “Attaining ...
- Source: drugdu
- 84
- March 25, 2024
FDA Approves Johnson & Johnson’s Edurant PED for Pediatric Patients With HIV

Davy James Expanded indication for Edurant in combination with other antiretroviral therapies includes treatment-naïve children with HIV-1 RNA <100,000 copies/mL aged at least 2 years and weighing between 14 kg and 25 kg. The FDA has approved an expanded indication for Johnson & Johnson’s Edurant PED (rilpivirine) in combination with other antiretroviral therapies (ART) to treat HIV-1 in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) aged at least 2 years and weighing between 14 kg and 25 kg.1 Edurant is an HIV-1 specific, nonnucleoside reverse transcriptase inhibitor previously approved in combination with ART in treatment-naïve patients 12 years of age and older who weigh at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. “Decades of experience with the global HIV epidemic have made it clear that new and improved treatment options are needed to support the diverse population of people living with HIV on their ...
- Source: drugdu
- 149
- March 23, 2024
【EXPERT Q&A】What is FDA Food grade certification?

Drugdu.com expert’s response: FDA food-grade certification typically refers to the certification or approval by the U.S. Food and Drug Administration (FDA) for food-related products. This certification generally includes two types: 1.Food Additive Approval: FDA’s certification of food additives involves the FDA approving a substance for use in food processing to improve the quality, freshness, taste, or other characteristics of food. These food additives may include preservatives, sweeteners, colorants, thickeners, etc. Once FDA approval is obtained, these additives can be legally used in food processing. 2.Food Contact Material Certification: FDA’s certification of food contact materials refers to the FDA approving a material for use in the manufacture or processing of food or potable water. These materials may include food packaging, containers, manufacturing equipment, etc., used to protect food from contamination or pollution. FDA-certified food contact materials typically comply with FDA regulations, ensuring that they do not pose a hazard to food ...
- Source: drugdu
- 121
- March 22, 2024
FDA Approves Idorsia’s Tryvio for Once-Daily Treatment of Difficult-to-Control Hypertension

Davy James Tryvio (aprocitentan) approved in combination with other antihypertensive drugs to lower hypertension in adults whose blood pressure is not adequately controlled by other therapies. The FDA has approved Idorsia Ltd’s Tryvio (aprocitentan) to reduce hypertension in combination with other antihypertensive drugs in adults whose blood pressure is not adequately controlled by other therapies. Tryvio is an endothelin receptor antagonist that interferes with the binding of endothelin (ET)-1 to ETA and ETB receptors.1 “Today, there are millions of Americans whose blood pressure is not well-controlled despite existing therapies. This is a major public health issue leading to a high incidence of cardio- and cerebrovascular events,” Jean-Paul Clozel, MD, CEO of Idorsia said in a press release. “In order to help address this issue, Idorsia developed aprocitentan, an endothelin receptor antagonist suited to the treatment of these patients. Idorsia conducted an ambitious clinical program in patients remaining hypertensive despite a ...
- Source: drugdu
- 100
- March 22, 2024
FDA Grants Accelerated Approval to Takeda’s Iclusig for Ph-Positive Acute Lymphoblastic Leukemia

Davy James Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia. The FDA has granted accelerated approval to Takeda’s supplemental New Drug Application for Iclusig (ponatinib) plus chemotherapy to treat adults with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL).1,2 Iclusig is the only pan-mutational, third-generation tyrosine kinase inhibitor (TKI) that targets BCR::ABL1, an abnormal tyrosine kinase expressed in Ph-positive ALL and chronic myeloid leukemia (CML). Iclusig can also treat all known single, treatment-resistant mutations, including T315I. “This label expansion for Iclusig is an incredibly exciting milestone, allowing US adult patients with newly diagnosed Ph-positive ALL to have an approved, targeted treatment option in the frontline,” Awny Farajallah, MD, chief medical officer, oncology at Takeda, said in a press release. “We are thrilled that the FDA has recognized the potential of Iclusig to fill a large gap in care for these ...
- Source: drugdu
- 158
- March 21, 2024
March 19, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA provided an update on our evaluation of quality and performance issues related to plastic syringes made in China, and announced additional recommendations and actions the FDA is taking to address these issues. The FDA issued warning letters to three entities that describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S. The FDA expects these entities to fully address the violations described in the warning letters and will take additional steps as appropriate. We remain concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance, and our evaluation is ongoing. This is an evolving situation, and we will continue to keep the ...
- Source: drugdu
- 93
- March 21, 2024
FDA’s Oncologic Drugs Advisory Committee Recommends Earlier Treatment with Carvykti for Relapsed or Refractory Multiple Myeloma

Don Tracy, Associate Editor In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment. Johnson & Johnson (J&J) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended Carvykti (ciltacabtagene autoleucel, cilta-cel) in earlier lines of treatment for adult patients with relapsed or refractory multiple myeloma who have previously undergone at least one line of therapy, including both a proteasome inhibitor and an immunomodulatory agent, and who are also refractory to lenalidomide. The 11-0 unanimous vote in favor of the treatment resulted from Phase III CARTITUDE-4 study data, which showed an encouraging risk-benefit evaluation for its proposed indication.1 “We are pleased with the advisory committee’s support for Carvykti in earlier lines of treatment based on the CARTITUDE-4 data,” said Jordan Schecter, MD, VP, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine, in a press ...
- Source: drugdu
- 150
- March 20, 2024
FDA Approves First Gene Therapy for Children with Metachromatic Leukodystroph

Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and nervous system. It is caused by a deficiency of an enzyme called arylsulfatase A (ARSA), leading to a buildup of sulfatides (fatty substances) in the cells. This buildup causes damage to the central and peripheral nervous system, manifesting with loss of motor and cognitive function and early death. It is estimated that MLD affects one in every 40,000 individuals in the United States. There is no cure for MLD, and treatment typically focuses on supportive care and symptom management. “This is the first FDA-approved treatment option for children who have this rare genetic disease,” said Peter Marks, M.D., Ph.D., director of ...
- Source: drugdu
- 150
- March 20, 2024
BeiGene’s Tevimbra receives FDA approval to treat advanced oesophageal cancer

BeiGene’s PD-1 inhibitor Tevimbra (tislelizumab-jsgr) has been approved by the US Food and Drug Administration (FDA) to treat advanced oesophageal squamous cell carcinoma (ESCC). The authorisation specifically applies to adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Oesophageal cancer is the sixth most common cause of cancer-related deaths globally and ESCC accounts for almost 90% of cases. More than two-thirds of patients with oesophageal cancer have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases. BeiGene’s Tevimbra, which is already approved in the EU for advanced or metastatic ESCC after prior chemotherapy, is designed to aid the body’s immune cells to detect and fight tumours. The FDA’s decision on the therapy was based on positive results from the late-stage RATIONALE 302 trial, which compared its ...
- Source: drugdu
- 123
- March 20, 2024
FDA Approves Tevimbra, BeiGene’s Treatment for Adults with Unresectable or Metastatic Esophageal Squamous Carcinoma

Don Tracy, Associate Editor Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors. The FDA has approved BeiGene’s Tevimbra (tislelizumab-jsgr) for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors. The FDA based the approval on findings from the Phase III RATIONALE 302 trial (NCT03430843), which showed a significant survival benefit with Tevimbra compared to chemotherapy, with an overall survival rate of 8.6 months compared with 6.3 months in patients administered chemotherapy. Further, the treatment was found to be safer altogether, with manageable adverse effects.1 “Today’s FDA approval of Tevimbra for patients with ESCC who have previously received chemotherapy, along with its ongoing review of our [biologics license application] for first line ESCC patients, represents a significant step in our commitment ...
- Source: drugdu
- 133
- March 19, 2024

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