Search Results for “FDA” – Page 25 – media

FDA Accepts New Drug Application for Shorla Oncology’s Novel Treatment for Breast, Ovarian Cancer

Pharmaceutical Executive Editorial Staff SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation. The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. The NDA was given a Prescription Drug User Fee Act action date of June 29, 2024. “This innovative drug will offer hospital pharmacists and patients access to a differentiated, ready to administer, injectable product with unique characteristics that’s expected to facilitate rapid adoption once approved,” said Orlaith Ryan, Shorla Oncology chief technical officer and cofounder, in a press release. The novel therapy is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s. The ready-to-dilute liquid formulation eliminates the need for powder reconstitution, which Shorla stated will bolster the product’s efficiency and lower the ...
- Source: drugdu
- 203
- January 13, 2024
FDA Fast Tracks SELLAS Life Sciences’ CDK9 Inhibitor for Acute Myeloid Leukemia

Pharmaceutical Executive Editorial Staff SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in an ongoing Phase I/II study in combination with Venclexta and Vidaza for patients with relapsed or refractory acute myeloid leukemia. The FDA has granted Fast Track Designation to SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). The regulatory action was based on safety and efficacy data for the drug, which is being evaluated in an ongoing Phase I/II study (NCT04588922) in combination with Venclexta (venetoclax) and Vidaza (azacytidine) for patients with AML. “Receiving fast track designation for SLS009 for relapsed or refractory AML, following the recent orphan drug designation for the same indication, underscores the potential for SLS009 and highlights the critical unmet need for patients with AML who face a poor prognosis due to the progressive nature of the disease,” ...
- Source: drugdu
- 157
- January 12, 2024
FDA’s Preliminary Review of GLP-1 Meds Finds No Tie to Suicidal Thoughts, Actions

The FDA has found no clear relationship between GLP-1 drugs, such as Ozempic and Mounjaro, and reports of suicidal thoughts or actions. But the agency added that it can’t definitively rule out the risk, and its review is ongoing. By FRANK VINLUAN An FDA inquiry has found no evidence so far that GLP-1 drugs for diabetes and weight loss cause suicidal thoughts or actions. The review was prompted by reports in the FDA Adverse Event Reporting System, or FAERS, a database that collects information about adverse events that may be linked to a medication. A report in FAERS does not establish causation, nor has information in the reports been verified. The FDA said on Thursday that over the last several months, it has reviewed reports of suicidal thoughts or actions in FAERS as well as data from clinical trials. The information in these reports was limited and can be influenced ...
- Source: drugdu
- 97
- January 12, 2024
J&J’s Megadyne restricts use of electrodes over burn risk, triggering Class I FDA notice

Dive Brief The Food and Drug Administration has categorized an urgent medical device correction from Johnson & Johnson’s Megadyne as a Class I event. Megadyne contacted customers last month to restrict the use of four electrode products in children under the age of 12 years. The products are staying on the market with a narrower label. The J&J unit took the action after receiving reports of burn injuries that could be particularly harmful to children. Megadyne has received reports of 99 injuries and no deaths, according to the FDA’s Monday recall notice. Dive Insight The electrode pads help direct currents from certain instruments used during surgery through the patient’s body to prevent the risk of energy concentrating in one area and burning the patient, according to the FDA. Megadyne sent an urgent field safety notice about the burn risk in June, leading to a Class I notice from the FDA ...
- Source: drugdu
- 175
- January 11, 2024
ProfoundBio’s Rinatabart Sesutecan Granted FDA Fast Track Designation for Ovarian Cancer

Pharmaceutical Executive Editorial Staff Rinatabart sesutecan (Rina-S; PRO1184) is under evaluation for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. The FDA has granted Fast Track designation to ProfoundBio’s rinatabart sesutecan (Rina-S; PRO1184) to treat patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.1 The novel folate receptor alpha (FRα)–targeted antibody-drug conjugate (ADC) is comprised of an FRα-directed antibody linked to sesutecan, which is an investigational, cleavable hydrophilic linker, and the topoisomerase 1 inhibitor payload exatecan. “Our receipt of Fast Track designation from the FDA underscores our belief in the tremendous promise of Rina-S as a potential best-in-class FRα ADC to address the significant need for improved treatment options for advanced ovarian cancer,” said Naomi Hunder, chief medical officer of ProfoundBio, in a press release.1 “FRα is a highly prevalent antigen in ovarian cancer and Rina-S has shown encouraging antitumor activity and tolerability in ...
- Source: drugdu
- 84
- January 10, 2024
FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization

Today, the U.S. Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization. This update will facilitate broader adoption of VHP as a sterilization method for the medical device industry, is part of the agency’s multi-pronged approach to reducing the use of ethylene oxide (EtO) where possible and further supports the agency’s efforts to advance medical device supply chain resiliency. Effective sterilization processes are necessary for certain devices to be safe because sterilization inactivates or kills potentially harmful microorganisms. In addition to effectively inactivating or killing potentially harmful microorganisms, sterilization processes must ...
- Source: drugdu
- 131
- January 10, 2024
Nanowear gets FDA clearance for undergarment that estimates blood pressure

Dive Brief Nanowear has received 510(k) clearance for AI-enabled software that allows its wearable undergarment to estimate blood pressure. The Food and Drug Administration decision covers software that processes electrocardiogram (ECG) data, heart sounds and thoracic impedance captured by the Simplesense wearable device to monitor blood pressure at home, in healthcare facilities and during medical research. Nanowear is pitching the software as the “first non-invasive, cuffless, continuous blood pressure monitor, and diagnostic.” The company cited Biobeat Technologies’ wrist and chest monitor as a predicate blood pressure device in its 510(k) filing. Dive Insight Simplesense is a cloth-based undergarment that wraps around the wearer’s torso and over one shoulder. The medical device features two ECG leads, plus sensors for recording heart sounds and activity, and for measuring respiration rate through thoracic impedance. Nanowear made the device to enable physicians and researchers to remotely capture data on patients without disrupting their lives. ...
- Source: drugdu
- 160
- January 9, 2024
FDA Authorizes Florida’s Drug Importation Program

Today, the U.S. Food and Drug Administration authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada. Through this pathway, the FDA may authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety. President Biden’s Executive Order on Promoting Competition in the American Economy directed the FDA to work with states and Indian tribes on these plans to reduce costs to American consumers while supporting public health and safety. Florida’s SIP is authorized for two years from the date the FDA is notified of the first shipment of drugs ...
- Source: drugdu
- 83
- January 9, 2024
BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod

By PharmaCompass BMS buys Karuna for US$ 14 billion; Astra-Ionis’ nerve damage drug bags FDA nod This week’s Phispers is a double bill with news from last week and the first days of the New Year. Bristol Myers Squibb (BMS) and AstraZeneca have been on year-end shopping sprees with the former picking up Karuna Therapeutics for a whopping US$ 14 billion and the latter expanding its already dominant presence in China through an acquisition and a deal. Novo Nordisk is investing over US$ 2 billion, this time in Ireland, to meet the skyrocketing demand for its blockbuster diabetes and weight-loss drugs, Ozempic and Wegovy. In drug approvals, AstraZeneca and Ionis Pharmaceuticals’ drug Wainua became the first self-administered treatment in the United States for a rare nerve damage disease. In trial news, a potential first-in-class small molecule that was on course to becoming the first new drug approved in 20 years ...
- Source: drugdu
- 122
- January 8, 2024
FDA Grants Fast Track, Breakthrough Designations to CG Oncology Inc’s Cretostimogene Grenadenorepvec

Pharmaceutical Executive Editorial Staff Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors. The FDA granted Fast Track and Breakthrough Therapy designations to CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 tumors.1 The novel, intravesically delivered oncolytic immunotherapy is currently being evaluated in the Phase III BOND-003 and the Phase II CORE-001 clinical trial in combination with pembrolizumab (Keytruda) in the same indication. An investigator-sponsored clinical trial is evaluating cretostimogene grenadenorepvec in combination with nivolumab (Opdivo) for the treatment of muscle invasive bladder cancer. The regulatory action was based on data from an ongoing clinical trial program, including the Phase III BOND-003 trial (NCT04452591), which ...
- Source: drugdu
- 145
- January 6, 2024

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