Search Results for “FDA” – Page 34 – media

FDA Grants Fast Track Designation to Sellas Life Sciences’ SLS009 for Lymphoma

Don Tracy, Associate Editor SLS009 is a novel CDK9 inhibitor under investigation for the treatment of relapsed/refractory peripheral T-cell lymphomas. Sellas Life Sciences announced that the FDA has granted Fast Track Designation to SLS009, its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL). The designation intends to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.1 “The FDA’s decision to grant SLS009 Fast Track designation signifies an important milestone towards developing a safe and effective treatment for PTCL, a group of aggressive and rare non-Hodgkin lymphomas, and underscores the urgent need for innovative therapies such as SLS009 that can significantly improve the outcome of PTCL patients,” said Angelos Stergiou, MD, ScD hc, president, CEO, Sellas, in a company press release. “SLS009 has demonstrated very promising clinical responses in PTCL patients in the recently completed ...
- Source: drugdu
- 104
- November 3, 2023
Amgen scores FDA approval for Stelara biosimilar

Amgen’s interchangeable biosimilar version of Johnson & Johnson’s (J&J) Stelara, dubbed Wezlana (ustekinumab-auub), has received an US Food and Drug Administration (FDA) approval. The interchangeable biosimilar was approved for use in multiple inflammatory diseases, including for adults with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderate to severe active Crohn’s disease and moderate to severe active ulcerative colitis. The agency approved Wezlana after a comprehensive review of scientific evidence, which showed that Wezlana was highly similar to ustekinumab and there were no clinically meaningful differences between the products in regard to safety, purity, and potency. Stelara was first approved by the FDA for the treatment of adult patients with moderate to severe plaque psoriasis in September 2009. The FDA later approved the IL-12/IL-23 inhibitor’s use in moderate to severe Crohn’s disease in November 2016, and later for active psoriatic arthritis and ulcerative colitis. ...
- Source: drugdu
- 95
- November 3, 2023
Merck’s Keytruda nabs FDA nod in biliary tract cancer, catching up with AstraZeneca’s Imfinzi

After AstraZeneca’s Imfinzi last year claimed new territory in the biliary tract cancer space, Merck’s Keytruda has hit the scene with an FDA nod to match its rival. The approval in locally advanced unresectable or metastatic biliary tract cancer, combined with the chemotherapies gemcitabine and cisplatin, marks Keytruda’s sixth U.S. nod in gastrointestinal cancer, Merck said. The FDA based the approval on data from the company’s Phase 3 KEYNOTE-966 trial, which showed that the Keytruda-chemo combo extended patients’ survival time compared with chemotherapy alone. In the study, patients in the treatment arm lived a median 12.7 months, compared to 10.9 months for those on solo chemo. The Keytruda-chemo combo reduced the risk of death by 17% over solo chemotherapy, researchers found. In addition, Keytruda-treated patients experienced a longer median duration of response at 9.7 months, compared with 6.9 months for solo chemotherapy. Merck is “proud” to offer the new treatment ...
- Source: drugdu
- 97
- November 3, 2023
FDA posts updated safety data on Bayer’s Essure, notes progress on improving study

Dive Brief A postmarket surveillance study has linked Bayer’s Essure birth-control implant to a numerically higher rate of some safety outcomes than laparoscopic tubal sterilization (LTS). The latest interim analysis of the study, which the Food and Drug Administration asked Bayer to run, shows trends seen in previous years persisted. Rates of gynecologic surgical procedures and endometrial ablation were numerically higher in the Essure group. Bayer has acted on the FDA’s request for actions to improve follow-up rates in the study, leading the administration to remove the “inadequate” progress tag it applied to the trial last year. Dive Insight The origins of the postmarket surveillance study date back to 2016, when the FDA asked Bayer to collect data on the device. Bayer stopped selling the device in the U.S. two years later, framing the action as a business decision rather than a reflection of the safety of a product that ...
- Source: drugdu
- 112
- November 2, 2023
FDA approves UCB’s inflammatory disease drug Bimzelx for plaque psoriasis

The US Food and Drug Administration (FDA) has approved UCB’s inflammatory disease drug to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.The decision makes Bimzelx (bimekizumab-bkzx) the first and only approved psoriasis treatment designed to selectively inhibit IL-17A and IL-17F, two key cytokines driving inflammatory processes. More than 7.5 million adults in the US are affected by some form of psoriasis, a chronic inflammatory condition caused by dysfunction of the immune system, which results in skin cells reproducing at a faster rate than normal.Up to 90% of patients with psoriasis have plaque psoriasis, characterised by dry, raised, red skin lesions (plaques) covered with silvery scales. The plaques may be itchy or painful and can occur anywhere on the body, including the scalp, elbows, knees and lower back. As well as its physical manifestations, psychological impact has been increasingly recognised as a significant part of ...
- Source: drugdu
- 135
- October 20, 2023
Mirum’s plans to expand Livmarli’s market get hit as FDA pushes approval date

The US Food and Drug Administration (FDA) has announced an extended review of the Supplemental New Drug Application (sNDA) for Mirum Pharmaceutical’s Livmarli (maralixibat) to treat patients with cholestatic pruritus in progressive familial intrahepatic cholestasis (PFIC). The company announced that the FDA extended the prescription drug user fee act (PDUFA) date to allow time for a full review of a submission provided in response to an FDA information request, which is deemed to be a major amendment. The date has been pushed from 13 December to 13 March, 2024. The news was announced after markets closed on 17 October. Earlier today, Mirum’s stock opened more than 4% lower than the previous day. Mirum submitted the sNDA in February of this year based on the Phase III MARCH trial. The study was the largest randomised trial conducted for patients with PFIC. A statistically significant difference in efficacy was reported between the ...
- Source: drugdu
- 155
- October 20, 2023
Ardelyx Nabs FDA Approval for First Phosphate Absorption Blocker in CKD

Pictured: Test-tube containing a blood sample for measuring serum phosphorus levels/iStock, Md Saiful Islam Khan The FDA on Tuesday gave the greenlight to Ardelyx’s tenapanor, now to be marketed under the brand name Xphozah, indicated to reduce serum phosphorus levels in patients with chronic kidney disease. Tuesday’s approval covers chronic kidney disease (CKD) patients on dialysis who had previously shown an inadequate response to phosphate binders, or who are otherwise intolerant to such therapies. Xphozah’s label bears no boxed warning but carries a precaution against severe diarrhea, the most common observed adverse event during the drug’s development. Ardelyx CEO Mike Raab called Tuesday’s approval an “important milestone” for dialysis patients, their families and the larger nephrology care community. Xphozah “represents a new mechanism and new option for patients who, despite treatment with phosphate binders, continue to have elevated phosphorus.” Xphozah is taken as 30-mg oral tablets twice-daily, before the morning and evening meals. Its ...
- Source: drugdu
- 107
- October 20, 2023
Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. Thanks to a new FDA approval, a continuous immunotherapy regimen for use on both sides of surgery is now available for certain patients. The approval, for Merck’s Keytruda, clears the PD-1 inhibitor to be used both as part of a neoadjuvant regimen before surgery and as an adjuvant therapy after surgery in patients with resectable NSCLC. Patients also take chemotherapy during presurgical treatment. In a coveted win for Merck, Keytruda’s updated label (PDF) already includes data showing that, compared with neoadjuvant chemo alone, the addition of perioperative Keytruda significantly cut the risk of death by 28% in the Keynote-671 study. Patients who took neoadjuvant chemo alone lived a median 52.4 months, while the median result for the Keytruda arm wasn’t reached by the time of the analysis, ...
- Source: drugdu
- 170
- October 19, 2023
FDA establishes new advisory committee to provide expertise on digital health

The US Food and Drug Administration (FDA) has set up a new advisory committee to provide expertise on digital health technologies (DHTs), such as artificial intelligence, digital therapeutics and remote patient monitoring. The Digital Health Advisory Committee, which should be fully operational next year, will advise the regulator on the benefits, risks and clinical outcomes associated with the use of DHTs, as well as identify risks, barriers or consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. The committee will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds, the FDA said, to “help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations”. The agency said it is currently seeking nominations of “appropriately qualified” candidates, setting an application deadline of 11 December. Jeff Shuren, director of the FDA’s Center for Devices ...
- Source: drugdu
- 202
- October 18, 2023
Bristol Myers Squibb’s Opdivo approved by FDA for expanded melanoma use

Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved by the US Food and Drug Administration (FDA) as an adjuvant treatment for adults and adolescents aged 12 years and older with completely resected stage 2B or 2C melanoma. The decision makes Opdivo, which is already approved in the US for use in certain melanoma patients, the only PD-1 inhibitor indicated as an adjuvant treatment for eligible patients with stages 2B, 2C and 3, as well as stage 4 completely resected melanoma. The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with more than 97,000 new cases expected to be diagnosed in the US overall this year. Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses. “Within five years ...
- Source: drugdu
- 115
- October 18, 2023

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