Search Results for “FDA” – Page 14 – media

IceCure submits final breast cancer cryoablation data to FDA

BY SEAN WHOOLEYIceCure Medical (Nasdaq:ICCM) announced today that it submitted final data to the FDA requesting marketing authorization for its ProSense system. Caesarea, Israel-based IceCure designed ProSense to deliver cryoablation that treats breast cancer in a 20-40-minute outpatient procedure. It seeks FDA authorization for treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense already holds FDA breakthrough device designation and has clearance in the U.S. for other indications. Those include treating benign tumors of the breast, and tumors in the kidney and liver. However, the FDA in 2022 denied IceCure’s de novo classification request for ProSense to treat patients with early-stage, low-risk breast cancer. In January of this year, the FDA agreed to reopen the de novo file. An affirmative response from the FDA provided IceCure with a potential pathway to clearance. The company submitted a five-year follow-up dataset from the ICE3 study and ...
- Source: drugdu
- 112
- April 22, 2024
GSK’s Five-in-One Meningococcal Vaccine Under Review by the FDA

Don Tracy, Associate Editor With a final decision expected next February, MenABCWY combines the protective elements of GSK’s existing vaccines to target the five primary serogroups of Neisseria meningitidis. GSK announced that the FDA has accepted for review an application for its five-in-one meningococcal vaccine MenABCWY. MenABCWY is a combination of GSK’s two existing vaccines, Bexsero and Menveo, and targets the five primary serogroups (A, B, C, W, and Y) of Neisseria meningitidis. These serogroups are credited with causing the majority of meningococcal disease (IMD) cases around the world. According to the company, a final decision is expected on February 14, 2025.1 “In the Phase III trial (NCT04502693), all primary endpoints were achieved for the MenABCWY vaccine candidate, including immunological non-inferiority to one dose of GSK’s Meningococcal Groups A,C,Y and W Vaccine, and non-inferior immune responses against 110 diverse MenB invasive strains (representing 95% of MenB strains circulating in the ...
- Source: drugdu
- 144
- April 20, 2024
FDA Approves Stelara Biosimilar Selarsdi to Treat Psoriasis, Psoriatic Arthritis

Davy James Alvotech’s and Teva’s Selarsdi (ustekinumab-aekn), the second FDA-approved biosimilar to Stelara, is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for patients aged 6 years and above with active psoriatic arthritis. Image credit: Maria | stock.adobe.com Alvotech’s and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) has been approved by the FDA as a biosimilar to Stelara (ustekinumab), which represents the second approval for a Stelara biosimilar.1 Selarsdi is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and for patients aged 6 years and above with active psoriatic arthritis. “The approval of Selarsdi—which is our second biosimilar approval this year—underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the US,” Thomas Rainey, ...
- Source: drugdu
- 78
- April 19, 2024
Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

The FDA clinical hold keeps Neumora Therapeutics from catching up to the field of biopharmaceutical companies pursuing the same target for schizophrenia. But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder. A Neumora Therapeutics drug candidate addressing a promising and competitive target for schizophrenia has been placed under an FDA clinical hold after new preclinical data emerged showing convulsions in rabbits that received the experimental treatment. The Neumora drug, NMRA-266, began Phase 1 testing last November. The clinical hold announced Monday pauses the study, which had dosed about 30 healthy participants so far. Watertown, Massachusetts-based Neumora said no convulsions have been observed in any of the study participants. The company added that it is working with the FDA to resolve the clinical hold and will provide an update on the program’s status when new information becomes available. “We are ...
- Source: drugdu
- 82
- April 17, 2024
FDA approves new administration routes for Xcopri

South Korea-based SK Life Sciences has received US Food and Drug Administration (FDA) approval for two new forms of administration of its epilepsy drug Xcopri (cenobamate), as an oral suspension mixed with water for mouth administration or via a nasogastric tube. Discovered and developed by SK Biopharmaceuticals, Xcopri is an anti-epileptic drug indicated for partial-onset seizures in adults. The therapy reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents, leading to a decreased occurrence of seizures. The oral form of the treatment is taken once daily. The FDA-approved label revision is based on findings from an open-label study comparing the bioequivalence of three ways of administering the medication: swallowing a whole tablet, taking a crushed tablet in water by mouth, and using a nasogastric tube to administer a crushed tablet in water. The approval addresses the needs of patients living with epilepsy, who are unable to swallow Xcopri tablets whole, ...
- Source: drugdu
- 104
- April 16, 2024
Candel wins FDA orphan drug designation for pancreatic cancer drug

The US Food and Drug Administration (FDA) has granted Candel Therapeutics’ immunotherapy candidate CAN-2409 (aglatimagene besadenovec) orphan drug designation for the treatment of pancreatic cancer. Orphan drug designations are granted to medicines intended to treat rare conditions and come with benefits such as tax credits for US-based clinical trials and potentially seven years of market exclusivity in the designated indication upon agency approval. Pancreatic cancer is one of the most lethal forms of cancer, with a survival rate beyond ten years of around 5%. CAN-2409 was also granted fast track designation in pancreatic cancer by the FDA in December 2023, meaning the candidate is in line for expedited development and review times. CAN-2409 is an off-the-shelf immunotherapy that is a combination of a genetically modified adenovirus and the herpes simplex virus thymidine kinase (HSV-tk) gene. The drug works by inducing T cell response at both the targeted tumour and at ...
- Source: drugdu
- 74
- April 16, 2024
Pfizer Asks FDA to Approve RSV Vaccine for Adults as Young as 18 Years Old

Mike HollanIt could be time for many Americans to add another vaccine to their list. Pfizer recently announced the results of a study for its RSV vaccine. While the vaccine is already approved for older Americans, the results of the study reportedly show that it is also effective for adults as young as 18. As such, Pfizer is asking FDA to approve the vaccine for adults aged 18 to 59. In a press release, Pfizer stated that Abrysvo met all of its primary endpoints for adults in specified age range who had an increased risk of RSV.1 The study was named MONeT, which is short for RSV Immunization Study in Adults at Higher Risk of Severe Illness. It was conducted to see the efficacy of the vaccine in adults who suffer from certain conditions, such as asthma, diabetes, and chronic obstructive pulmonary disease. These conditions put the patients at a ...
- Source: drugdu
- 142
- April 15, 2024
FDA Approves New Administration Methods for SK Life Science’s Xcorpi for Adults with Partial-Onset Seizures

Don Tracy, Associate Editor New methods allow the antiseizure treatment to be crushed and mixed with water for oral suspension or for use through a nasogastric tube. SK Life Science announced that the FDA has approved two new ingestion methods for Xcorpi (cenobamate tablets) CV, an antiseizure medication. As of today, the medication can be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube. These new methods of administration were approved as a result of the results of an open-label, randomized, single-center, three-period, six-sequence, crossover study showing biochemical similarity between three administration routes, including the aforementioned methods.1 “The approval addresses the needs of patients living with epilepsy who are currently taking, or who may benefit from starting XCOPRI, but are unable to swallow the tablets whole,” said Louis Ferrari, BS, RPh, MBA, VP, medical affairs, SK Life Science, in ...
- Source: drugdu
- 118
- April 13, 2024
Oryzon wins FDA approval to begin SCLC treatment trial

Oryzon Genomics is set to commence a Phase I/II clinical trial of iadademstat (ORY-1001) plus immune checkpoint inhibitors (ICI) in patients with first-line small cell lung cancer (SCLC). The development comes after the US Food and Drug Administration (FDA) cleared the Spain-based biotech’s investigational new drug application (IND) to initiate the study. The Phase I/II trial (NCT06287775) will be conducted and sponsored by the National Cancer Institute (NCI), enrolling 45-50 patients. In the first phase, patients will receive iadademstat on days 1, 8, 15, and 22 or days 1 and 15 of each cycle. Patients will also continue to receive their initial ICI treatment, Tecentriq (atezolizumab) intravenously (IV), or Imfinzi (durvalumab) IV over 60 minutes on day one of each cycle. Cycles will repeat every 28 days in the absence of disease progression or unacceptable toxicity. In the second phase of the study, patients are randomised to two different arms ...
- Source: drugdu
- 77
- April 11, 2024
Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

The CAR T-therapies Abecma and Carvykti may now be used in earlier lines of treatment for multiple myeloma. The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products.Relapse is common in multiple myeloma, and when it happens, a drug that worked for a patient before might no longer help. Two cell therapies already approved for this cancer may now be used in earlier lines of treatment, a regulatory decision that brings additional choices for patients who have exhausted standard multiple myeloma treatment options. Multiple myeloma is a blood cancer that develops in the plasma cells in bone marrow. The expanded FDA approvals announced Friday cover Abecma, from Bristol Myers Squibb and 2seventy bio, and Carvykti, from Johnson & Johnson and Legend Biotech. Both products are CAR T-therapies made by engineering a patient’s own immune cells to go after BCMA, a protein ...
- Source: drugdu
- 97
- April 10, 2024

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