Search Results for “FDA” – Page 18 – media

BeiGene’s “tislelizumab” FDA approved

On March 15, 2024, BeiGene announced that the U.S. Food and Drug Administration (FDA) has approved tislelizumab (Chinese trade name: BAIZEAN®; English trade name: TEVIMBRA®) as mono-therapy to treat adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy (without PD-1/L1 inhibitors). Tislelizumab is expected to be available in the United States in the second half of 2024. The approval was based on results from the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population. Tislelizumab demonstrated a statistically significant and clinically meaningful survival benefit compared with chemotherapy. In the ITT population, median overall survival (OS) was 8.6 months (95% CI: 7.5, 10.4) in the tislelizumab group compared with 6.3 months (95% CI: 5.3, 7.0) in the chemotherapy group (p=0.0001; hazard ratio [HR]=0.70 [95% CI: 0.57, 0.85]). The safety profile of tislelizumab is superior to that of chemotherapy. The most common ...
- Source: drugdu
- 117
- March 19, 2024
FDA approves Mirum’s Livmarli to treat cholestatic pruritus in rare liver disease patients

The US Food and Drug Administration (FDA) has approved Mirum Pharmaceuticals’ Livmarli (maralixibat) oral solution to treat cholestatic pruritus in patients aged five years and older with progressive familial intrahepatic cholestasis (PFIC). Estimated to affect one in every 50,000 to 100,000 births in the US and Europe, PFIC is a rare genetic disorder that causes progressive liver disease, typically leading to liver failure. Signs and symptoms of the condition usually begin in infancy and include severe pruritus (itching), jaundice and a failure to grow at the expected rate. The FDA’s decision on the therapy covers a broad range of PFIC subtypes and is supported by positive results from the late-stage MARCH study, which included 93 patients across a range of genetic PFIC forms as well as unidentified mutational status. Results showed a “highly statistically significant” reduction in pruritus severity for those receiving Livmarli compared with placebo, Mirum outlined. Chris Peetz, ...
- Source: drugdu
- 128
- March 19, 2024
ImmVira’s oncolytic product MVR-T3011 IT Intratumoral Injection Receives FDA Fast Track Designation for HNSCC Treatment

SHENZHEN, China, March 15, 2024 /PRNewswire/ — ImmVira has recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for oncolytic virus product MVR-T3011 IT (intratumoral injection) for the treatment of recurrent or metastatic head and neck squamous cell cancer with disease progression after platinum-based chemotherapy and at least one prior line of anti-PD1/PDL1 therapy. Fast track designation is intended to facilitate the development and expedite the review of drugs targeting serious conditions with unmet medical needs. The Fast Track designation was sought based on the promising potential of MVR-T3011 IT to meet the unmet medical needs associated with HNSCC. Supporting evidence for this request was derived from Phase I/II trials conducted in both the United States and China, focusing on evaluating the efficacy, safety, and durability of response in patients with HNSCC. HNSCC has become a growing public health concern, with increases in incidence ...
- Source: drugdu
- 89
- March 19, 2024
Intuitive lands FDA clearance for new da Vinci robot

Dive Brief Intuitive Surgical said Thursday it received 510(k) clearance from the Food and Drug Administration for a fifth-generation robotic surgery system intended to help the company keep its dominant market share in the face of looming competition. The da Vinci 5 system incorporates features that surgeons have long sought, such as feedback that simulates the feel of the patient’s body tissue, a smaller physical footprint in the operating room, and better console ergonomics. The improvements “can help drive incremental demand for the system and raise the bar for competition in the future,” William Blair analyst Brandon Vazquez said Friday in a note to clients. Dive Insight Intuitive is preparing for competitive challenges from Medtronic and Johnson & Johnson, as well as a wave of startups hoping to vie for a piece of the growing market. The robot maker, which saw its procedure volumes increase by 21% in the fourth ...
- Source: drugdu
- 131
- March 18, 2024
Fresenius Kabi receives FDA warning letter over issues at ex-Ivenix site

Dive Brief Fresenius Kabi has received a warning letter related to the large-volume infusion pumps that it acquired through its $240 million takeover of Ivenix. The Food and Drug Administration sent the letter after inspectors found fault with the handling of corrective and preventive actions for the Ivenix Infusion System. Fresenius took too long to complete investigations, the inspectors found, and failed to establish certain procedures. FDA inspectors visited the site in Massachusetts five months after Fresenius began recalling Ivenix infusion pumps in response to a leak risk that could cause the devices to fail. Dive Insight Fresenius bought Ivenix to strengthen its medtech business, particularly in the U.S., and support its growth strategy. Management has called for patience as Ivenix rolls out its new pump, with Fresenius CEO Michael Sen telling investors that “any new product takes time to hit [its] stride” on an earnings call in February. The ...
- Source: drugdu
- 141
- March 18, 2024
FDA Approves Madrigal Pharma NASH Drug

The FDA has approved Madrigal Pharmaceuticals drug Rezdiffra as a treatment for the fatty liver disease NASH (also called MASH). It’s the first treatment for the chronic condition, which has been growing in prevalence. By FRANK VINLUAN A chronic metabolic disease in which fat buildup leads to worsening liver function that can ultimately require an organ transplant now has its first FDA-approved therapy, a once-daily pill developed by Madrigal Pharmaceuticals. The FDA decision Thursday is for adults with noncirrhotic non-alcoholic steatohepatitis, or NASH. The approval specifically covers those who have reached the point of moderate-to-advanced liver scarring, which is also called fibrosis. The Conshohocken, Pennsylvania-based company’s drug, known in development as resmetirom, will be marketed under the brand name Rezdiffra. “We’ve had patients waiting and waiting for something that could impact underlying fibrosis in the setting of NASH, and this truly represents a milestone achievement that frankly I, and many ...
- Source: drugdu
- 119
- March 18, 2024
FDA Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical Product Safety, and Strengthen Public Health

Today, the U.S. Food and Drug Administration (FDA) announced it is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding will allow the agency to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s infrastructure and facilities. The request includes an increase of $495 million—or 7.4 percent above the FY 2023 funding level. The FDA’s request reflects the agency’s top priorities in key areas of importance for human and animal health. “The FDA continues to protect the health and well-being of millions of people,” said FDA Commissioner Robert M. Califf, M.D. “This new funding request will help us build on our accomplishments and also modernize our agency and operations as we plan for the future. Our request for critical investments will help us address our most urgent ...
- Source: drugdu
- 120
- March 15, 2024
Everest Medicines’ Partner Calliditas Therapeutics Announces U.S. FDA Grants an Additional Seven-Year Orphan Drug Exclusivity Period for Nefecon®

SHANGHAI, March 12, 2024 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”)’s licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) announced that the U.S. FDA has granted an orphan drug exclusivity period of seven years for Nefecon®, expiring in December 2030 based on Calliditas obtaining full approval with a new indication for this drug product in December 2023. Following full approval in December 2023, Nefecon® is indicated “to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression”. The exclusivity period reflects the new indication covering all adult patients with primary IgAN at risk of disease progression based on a confirmed reduction of kidney loss reflecting a clinical benefit on kidney function for adult patients with primary IgAN. “We congratulate our partner for receiving seven more years of market exclusivity for Nefecon® in the ...
- Source: drugdu
- 96
- March 15, 2024
FDA Approves Expanded Indication for Praluent to Lower LDL-C in Pediatric Patients with HeFH

Davy James Regeneron’s PCSK9 inhibitor approved to reduce low-density lipoprotein cholesterol in patients 8 years of age and older with heterozygous familial hypercholesterolemia. The FDA has approved an expanded indication for Regeneron’s PCSK9 inhibitor Praluent (alirocumab) to include patients 8 years of age and older for the reduction of low-density lipoprotein cholesterol (LDL-C) in those with heterozygous familial hypercholesterolemia (HeFH).1 In clinical trials, the fully human monoclonal antibody, which binds and inhibits to circulating PCSK9, has been found to lower LDL-C in patients with hyperlipidemia either as a monotherapy or combined with other lipid-lowering therapies (LLTs).2 “Many children with (HeFH) are able to substantially improve their LDL-C (bad cholesterol) with currently available therapies,” said Mary P. McGowan, MD, chief medical officer of the Family Heart Foundation, in a press release. “But for those children whose LDL-C remains dangerously high, this approval is an important milestone as it gives these children ...
- Source: drugdu
- 171
- March 13, 2024
FDA Grants Accelerated Approval to Brukinsa Plus Gazyva for Relapsed or Refractory Follicular Lymphoma

Davy James BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies. The FDA has granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) in combination with Roche’s Gazyva (obinutuzumab) for patients with relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy.1 Brukinsa is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies, such as chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma; Waldenström’s macroglobulinemia; patients with mantle cell lymphoma (MCL) previously treated with at least one prior therapy; and patients with relapsed or refractory marginal zone lymphoma previously treated with at least one anti-CD20-based regimen.1 Gazyva is a CD20-directed cytolytic antibody indicated in combination with chlorambucil for the treatment of patients with previously untreated CLL; in combination with chemotherapy ...
- Source: drugdu
- 133
- March 12, 2024

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