Search Results for “FDA” – Page 48 – media

Abiomed heart pump recall labeled Class I by FDA, no deaths reported

The FDA said Monday that Abiomed, the heart device maker bought by Johnson & Johnson last year for $16.6 billion, is recalling some sets of the Impella 5.5 heart pump with the SmartAssist function after receiving complaints that purge fluid has leaked from the purge sidearm of the pump. The FDA has identified the action as a Class I recall, the most serious kind, meaning that continued use may cause serious injuries or death, unless corrective measures are taken. The Impella 5.5 with SmartAssist System is used for up to 14 days to support the pumping chambers of the heart when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack, open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy, the FDA said in a statement. The FDA warned that if a purge leak occurs, “the system ...
- Source: drugdu
- 147
- June 7, 2023
FDA OKs Injectafer for Iron Deficiency Anemia in Heart Failure

Megan Brooks The US Food and Drug Administration (FDA) has expanded the indication for ferric carboxymaltose injection (Injectafer, Daiichi Sankyo/American Regent) to include treatment of iron deficiency in adults with New York Heart Association (NYHA) class II/III heart failure (HF). “This new indication for Injectafer marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure,” Ravi Tayi, MD, MPH, chief medical officer at American Regent, said in a news release. Ferric carboxymaltose injection is also indicated for the treatment of iron deficiency anemia in adults and children as young as 1 year of age who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have nondialysis dependent chronic kidney disease. The new indication in HF was supported by data from the CONFIRM-HF randomized controlled trial that evaluated the efficacy and safety of ferric carboxymaltose injection ...
- Source: drugdu
- 131
- June 7, 2023
Dana-Farber research supports FDA approval of new therapy for metastatic breast cancer

Sacituzumab govitecan, a novel antibody drug-conjugate therapy was granted accelerated approval on February 3, 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic HR+, HER2- breast cancer. The FDA action was based on the results of TROPICS-02, a study in which Dana-Farber Cancer Institute’s Sara Tolaney, MD, MPH, helped lead and which was presented at the European Society of Medical Oncology annual meeting in September 2022 as well as the American Society of Clinical Oncology meeting in June 2022. Researchers reported that the sacituzumab govitecan produced a statistically significant improvement in overall survival rates compared to chemotherapy. The overall survival rate for patients taking part in the global phase 3 study was 14.4 months for those who received sacituzumab govitecan and 11.2 for those given chemotherapy. The sacituzumab arm of the study also showed superior response rates as well as prolonged median progression free survival ...
- Source: drugdu
- 146
- June 6, 2023
FDA allows temporary import of unapproved Chinese cancer drug to ease U.S. shortage

The U.S. Food and Drug Administration has authorized the temporary importation of an unapproved chemotherapy drug from China in effort to ease an acute shortage of cancer drugs in the United States, according to an update posted to the agency’s website Friday. Qilu Pharmaceutical, which makes and markets cisplatin injections in China, received FDA permission to export the drug to the U.S. market weeks ago, a document shows. A letter dated May 24 from Qilu’s deputy general manager notified health care professionals of the approval. Qilu is coordinating with a Toronto-based company, Apotex, to distribute 50-milligram cisplatin vials in the U.S. Health care providers can begin ordering the drug Tuesday through their wholesalers. Cisplatin is a generic drug that has been available for decades in the U.S. and is distributed by several approved manufacturers. Those manufacturers have been unable to keep up with demand. Qilu’s version of cisplatin is not ...
- Source: drugdu
- 129
- June 6, 2023
Coherus, Junshi eye FDA finish line after agency finally conducts plant inspection

It’s been a long road for PD-1 partners Coherus BioSciences and Junshi Biosciences since their FDA rejection for cancer drug toripalimab more than a year ago, but the companies appear to be nearing the regulatory finish line in the U.S.Wednesday, Coherus said in a Securities and Exchange Commission filing that the U.S. FDA “successfully completed the required pre-licensing inspection” of Junshi’s manufacturing site in China. The FDA made three observations about plant deficiencies, but Coherus believes those are “readily addressable.” The partners plan to submit their response to the FDA in the coming weeks. Coherus says it’s planning to launch toripalimab in the U.S. after a potential FDA approval. The inspection comes after multiple regulatory delays. In May 2022, the FDA rejected the drug and requested a quality process change. At the time, the companies noted that a resubmission would take about six months because plant inspections had been delayed ...
- Source: drugdu
- 131
- June 5, 2023
FDA approves ANDA of 20mg generic Nitisinone capsules

Nitisinone capsules are indicated for patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine Analog Pharma and Dipharma have announced that the US Food and Drug Administration (FDA) has approved their 20mg nitisinone capsules, a generic equivalent of Swedish Orphan Biovitrum’s Orfadin. Analog already distributed the 2mg, 5mg and 10mg doses. Nitisinone capsules are used in the treatment of adult and paediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Tanya Carro, executive vice president of Analog Pharma, commented: “With the approval of the 20mg capsule, we now have a full complement of room temperature stable strengths for our generic Nitisinone. Considering that the 20mg is the most commonly prescribed strength of Orfadin, this will bring American patients with HT-1 a room temperature-stable treatment option. The addition of this new dosage form to our portfolio demonstrates ...
- Source: drugdu
- 106
- June 5, 2023
FDA hits iRhythm with warning letter over problems at heart monitor facility

Dive Brief The U.S. Food and Drug Administration has issued a warning letter to iRhythm Technologies after inspectors found fault with practices at a facility that makes its heart monitors. According to iRhythm, the FDA has alleged “nonconformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements.” iRhythm can continue to manufacture and sell its products and does not expect the warning letter to materially affect its financial results. However, the situation comes at a time when iRhythm is working to continue the recent recovery of sales of Zio AT. Dive Insight FDA inspectors concluded their assessment of iRhythm’s facility in Cypress, Calif. in August 2022. The FDA visit led to a Form 483 later that month. iRhythm took steps to address the concerns raised in the 483 but its actions failed to stop the FDA ...
- Source: drugdu
- 129
- June 4, 2023
AZ, Merck’s Lynparza wins FDA nod in prostate cancer subgroup following advisory committee vote

After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has followed suit.Lynparza can now be used in combination with Johnson & Johnson’s Zytiga and a corticosteroid to treat patients with mCRPC whose tumors have BRCA mutations. The approval limits Lynparza’s use in the mCRPC population to about 10% of patients. The FDA’s decision comes after agency staffers and a committee of outside experts argued that the drug only showed a favorable risk-benefit in that population. Results from the phase 3 PROpel trial showed that the combo cut the risk of disease progression or death by 34% compared with solo Zytiga in newly diagnosed mCRPC patients regardless of mutation status. However, the FDA noted a “significant design flaw” with the trial in its briefing documents ahead of the meeting. Specifically, the FDA argued that the study didn’t ...
- Source: drugdu
- 141
- June 3, 2023
FDA warns patients about compounded versions of Novo Nordisk’s Ozempic, Wegovy

In the rush to supply prescriptions of Novo Nordisk’s popular diabetes and weight loss meds, some pharmacies are making unauthorized versions of Ozempic and Wegovy, the FDA warned on Tuesday. Some compounding pharmacies, which are permitted to make drugs during times of shortage, are using unauthorized versions of semaglutide—the key active ingredient in the GLP-1 drugs. Compounding pharmacies are currently allowed to make Ozempic and Wegovy because they are in short supply. But they must use approved ingredients, the FDA points out. The agency has received adverse event reports after patients have used compounded semaglutide. In some cases, compounders may be using salt forms of semaglutide, called semaglutide sodium or semaglutide acetate, which have not been proven to be safe or effective. The FDA asks users of Ozempic and Wegovy to get a prescription from a licensed provider and only obtain drugs from state-licensed pharmacies or outsourcing facilities registered with ...
- Source: drugdu
- 169
- June 2, 2023
FDA warns about compounded semaglutide-based drugs

Tyler Patchen The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness. The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective. Novo Nordisk’s Ozempic and Wegovy, both of which contain semaglutide, are approved to treat type 2 diabetes and obesity, and demand for the drugs has soared over the last two years, given the ability of both therapies to help people lose weight. That demand has created a supply crunch, with both medications on the FDA’s shortages list. Though compounding medications is legal when drug shortages occur, the compounded versions ...
- Source: drugdu
- 116
- June 2, 2023

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