Search Results for “FDA” – Page 23 – media

FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting to discuss applications for Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti. The FDA will convene its Oncologic Drugs Advisory Committee (ODAC) for a full-day meeting March 15 to review the applications for BMS and 2seventy bio’s Abecma and J&J and Legend Biotech’s Carvykti in earlier treatment of multiple myeloma, a government filing shows. External experts invited by the FDA will review clinical data from Carvykti’s CARTITUDE-4 trial and Abecma’s KarMMa-3 study. In both cases, overall survival data will be the focus of the discussions. The meeting is expected to carry a lot of weight in the oncology community. For one, industry watchers are trying to take the FDA’s pulse around the benefit-risk profile of CAR-T cell therapies amid an investigation into a new safety signal ...
- Source: drugdu
- 98
- February 6, 2024
FDA Issues Warning of Contaminated Copycat Eyedrops

Mike Hollan The agency issued the warning against three brands of unapproved eyedrops designed to look like an approved brand. Be careful what you put in your eye. FDA has issued a warning for consumers to be on the lookout for copycat eyedrops.1 Specifically, consumers should be wary of purchasing eye drops that are designed to look like Bausch + Lomb’s Lumify brand. While Lumify is approved for redness relief, the noted brands are not approved by FDA. The brands are as follows: South Moon, Rebright, and FivFivGo. The agency’s warning was posted with an image showing how the three brands packaging and branding is designed to look exactly like Lumify. While each brand is clearly marked with its own name, the box’s all use the same color scheme and each feature the same drawing of a women’s eye with a purple tint to it. The drug information is also ...
- Source: drugdu
- 125
- February 5, 2024
Edwards receives FDA approval for first transcatheter tricuspid valve replacement treatment

Dive Brief Edwards Lifesciences received approval from the Food and Drug Administration for its Evoque tricuspid valve replacement system, making it the first company to bring a transcatheter treatment for tricuspid regurgitation to the U.S. Tricuspid regurgitation is a condition where the valve between the two right heart chambers doesn’t close properly, allowing blood to leak backward. Edwards’ Evoque device is inserted through a minimally invasive surgery and is designed to replace the tricuspid valve. Competitor Abbott has submitted a device for FDA approval called TriClip, which clips together a portion of the leaflets of the tricuspid valve to prevent blood from leaking back. The FDA plans to hold an advisory panel on Feb. 13 to discuss the device. Dive Insight The approval for Evoque is a “meaningful milestone for [Edwards] as well as for the industry,” Shagun Singh, an RBC Capital Markets analyst, wrote in a research note. The ...
- Source: drugdu
- 94
- February 4, 2024
FDA rejects Defender Pharma’s motion sickness nasal gel candidate

A nasal gel version of the motion sickness drug scopolamine has failed to make the grade with the FDA. The U.S. regulator has sent a complete response letter (CRL) to Defender Pharmaceuticals, rejecting DPI-396 for the prevention of nausea and vomiting induced by motion. Barry Feinberg, M.D., the CEO of Defender, a privately held St. Louis company, said in a release that the firm will schedule a meeting with the FDA so it can “understand the issues raised in the CRL so we can develop and implement a comprehensive action plan.” “We remain confident that our intranasal scopolamine is a safe and effective therapy,” Feinberg added. In 2012, the NASA teamed with Irvine, California-based Epiomed Therapeutics to develop a nasal spray version of scopolamine. Astronauts often experience motion sickness in space. Two years later, Defender purchased Epiomed, according to the St. Louis Post-Dispatch. Also working to develop the treatment has ...
- Source: drugdu
- 113
- February 1, 2024
FDA Grants Priority Review to AstraZeneca and Daiichi Sankyo’s Enhertu for HER2+ Solid Tumors

Enhertu has been approved by the FDA for indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. Image credit: David A Litman | stock.adobe.com The FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) from AstraZeneca and Daiichi Sankyo’s for Enhertu (trastuzumab deruxtecan [DXd]) to treat adults with previously treated unresectable or metastatic human epidermal growth factor 2 (HER2)-positive (immunohistochemistry [IHC] 3+) solid tumors with no satisfactory alternative therapeutic options.1 Enhertu is a HER2-directed antibody-drug conjugate (ADC) with approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction (GEJ) adenocarcinoma. “Today’s Priority Review for the first tumor-agnostic submission for Enhertu reflects the potential of this medicine to redefine the treatment of HER2-expressing cancers,” Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a press release. “Biomarkers for HER2 expression are already established in breast and gastric cancers, but we must now define them across tumor types. ...
- Source: https://www.pharmexec.com/authors/pharmaceutical-executive-editorial-staff
- 139
- January 31, 2024
Citing Severe Health Risks, FDA Issues Warning Against Using Tianeptine Products

Don Tracy, Associate Editor Atypical antidepressant linked to severe adverse effects and death as a result of misuse. This week, the FDA released a statement warning consumers to stay away from Neptune Resources’ Fix Elixir, Fix Extra Strength Elixir, and Fix Tablets. Citing potential adverse events (AEs) such as seizures, loss of consciousness, and death, the agency stated that they have continued to receive several reports of these AEs. After releasing an initial warning statement in November, the FDA sent a letter on January 11, 2024, to multiple retailers, stressing the need to pull Neptune’s Fix and any other tianeptine-containing products from their inventory. “Neptune’s Fix labels state the product contains tianeptine, but the product may contain other harmful ingredients not listed on the label,” the agency said in the statement “These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops, or ...
- Source: drugdu
- 97
- January 30, 2024
FDA Warns Drugmakers of Additional Cancer Risks Associated with CAR T-Cell Therapy

January 24, 2024 Don Tracy, Associate Editor New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products. On January 19, 2024, the FDA issued multiple notifications to drugmakers requiring boxed warnings to be added to all chimeric antigen receptor (CAR) T-cell therapy products, citing additional cancer risks associated with the treatment. The agency states that the letters “notify manufacturers of each such licensed product to update the package insert to include available information related to the risks and to update the Medication Guide for these products to identify the possibility of the increased risk of getting cancers, including certain types of cancers of the immune system.” Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. The letter stating these requirements has been sent to the manufacturers of Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, ...
- Source: drugdu
- 103
- January 26, 2024
Gilead’s Tecartus gets revised safety demand amid FDA’s push for CAR-T boxed warnings

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. Instead, the agency has adjusted the wording of a proposed boxed warning. In a revised letter (PDF) dated Jan. 23, the FDA is still pressing Gilead’s cell therapy unit Kite Pharma to include new language about the risk of T-cell malignancies in the black-box warning section of Tecartus’ label. But unlike its proposed boxed warning for other commercial CAR-T therapies, the FDA’s updated letter for Tecartus no longer names Tecartus patients specifically as having experienced T-cell malignancies. The FDA apparently took some time before uploading the new letter after taking down the original one, dated Jan. 19. The missing letter for Tecartus caused a brief period of confusion because the FDA says in all letters to ...
- Source: drugdu
- 90
- January 26, 2024
FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply. By FRANK VINLUAN Post a comment / at 7:04 PM Stricter safety warnings are coming for the cancer treatments known as CAR T-therapies. The FDA is instructing makers of the six approved cell therapies in the class to revise their labels to state that these treatments for cancer come with the risk of causing new cancers. The labels of CAR T-therapies already come with black box warnings that alert physicians and patients of risks that include an excessive immune response and neurotoxicity. Letters sent to the drugmakers last Friday instruct them to add additional language to the boxed warning stating that T cell malignancies have occurred following the treatment of ...
- Source: drugdu
- 95
- January 25, 2024
FDA Approves Balversa for Locally Advanced, Metastatic Urothelial Carcinoma

Today’s FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy. The FDA has approved Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.1 The regulatory action amends the accelerated approval granted by the FDA in April 2019 for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy. Balversa, a fibroblast growth factor (FGFR) inhibitor, is not recommended for patients who are eligible for, and were not previously administered, prior treatment with a PD-1 or PD-L1 inhibitor, according to the FDA.The FDA based the approval on data from Study BLC3001 cohort 1, which evaluated data from 266 patients with metastatic urothelial carcinoma harboring selected FGFR3 alterations and who previously received ...
- Source: drugdu
- 265
- January 23, 2024

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