This is the eighth generic version of the drug to treat insomnia.
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Orally dissolving film formulation of riluzole is now available for patients who have difficulty swallowing.
New data show efficacy in all forms of heart failure regardless of ejection fraction.
The prescribing information for Aduhelm now specifies its use in patients with a mild form of the disease.
The agency also granted tezepelumab priority review with a PDUFA date sometime in the first quarter of 2022.
The single-dose antibiotic with a one-hour infusion is approved to treat MRSA and other skin infections.
The company is transferring manufacturing of the final product to its own site in Austria.
Despite an advisory committee recommendation for approval, the FDA did not approve what would have been the first disease-modifying therapy for type 1 diabetes.
This approval comes days after Merck announced it would withdraw indication for third-line gastric cancer.
New, extended-release therapy for post-operative pain reduces the need for opioid pain relief.
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The move follows an April 29 vote by the FDA Oncology Drugs Advisory Committee.
Coverage now includes 85% of commercial lives.
Formulary adoption is a key step in achieving sales pull through starting in 2022, company officials said.
The therapy, a recombinant version, was developed to address supply and manufacturing issues.
Patients are being offered $500 to make the switch.
A recent study finds that the approval of a biosimilar was associated with a change in the trajectory of net prices.
Data from a phase 2/3 study will be presented in July.
The label for the type 2 diabetes treatment has been updated to include the risk of ketoacidosis and damage to the kidney.
But there is no benefit for patients receiving chemotherapy.
Kite plans to submit a supplemental BLA based on these findings.
The authorization is based on four studies that evaluated Actemra in more than 5,500 hospitalized patients.
Implementation of value-based approaches requires measurement of value, authors said.
Investigators looked at the association of antiparasitic drug prices with prescribing and prescription-filling behaviors and total outpatient treatment costs.
The start-up aims to develop real-world evidence that provides value to patients, insurers, and employers.
The anticancer therapy is now available in 21-count bottles to help accommodate dispensing.
The two organizations have created a fellowship program to help improve patient outcomes and reduce costs.
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