Evio Pharmacy Solutions plans to provide biosimilar alternatives for autoimmune and cancer therapeutics.
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Called Breyna, this drug-device combination generic product is a metered-dose inhaler, which contains both budesonide and formoterol.
In an interim analysis, Keytruda/Lynparza did not improve overall survival in patients with metastatic castration-resistant prostate cancer who progressed after treatment with chemotherapy.
After a phase 3 trial showed that Cabometyx/atezolizumab did not improve overall survival in patients with hepatocellular carcinoma, Exelixis officials have said they won’t be submitting an NDA for untreated patients with advanced liver cancer.
The FDA has asked for clinical data for Fasenra, which is being reviewed as a treatment for chronic rhinosinusitis with nasal polyps.
Adlarity delivers donepezil to patients using a skin patch, lowering the risk of gastrointestinal adverse events. It will be available in early fall 2022.
Opzelura is being reviewed as a treatment for vitiligo, a disease that causes the loss of skin color. The new PDUFA date is July 18, 2022.
Lynparza reduced the risk of death by 32% versus placebo. It is the first targeted treatment for patients with early breast cancer to be used after surgery or prior treatment.
The lots could contain trace amounts of sodium, silicon, chromium, aluminum, and cellulose, which could result in irritation or infection and has the potential to block blood vessels in the heart, lungs, or brain.
The FDA has granted first approval for cartridges for use with Apokyn for Parkinson’s. Other approvals include: a generic of anticancer therapy Vidaza, the antibacterial Erythrocin, and the anti-epilepsy therapy Lamictal.
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B. Braun is recalling five lots because of fluid leakage, which could expose patients to a bacterial or fungal infection.
This expands commercial coverage to 118 million lives and Medicare coverage to 7.1 million lives.
The company will distribute nalmefene for no profit, which is part of the company’s bankruptcy filing and settlement with states.
Supplemental applications have been submitted for the cancer therapies Nubeqa and Tibsovo, the gout treatment Krystexxa, and Oxlumo, which treats a rare disease.
Besremi is included as an option to treat the rare blood disorder polycythemia vera regardless of treatment history and for use in both low- and high-risk settings.
With a PDUFA date of Aug. 4, 2022, the FDA plans to hold an advisory committee meeting on resubmitted data for Nuplazid in patients with Alzheimer's disease who have psychosis.
Aadi Bioscience recently launched Fyarro, the first FDA-approved therapy to treat an ultra-rare sarcoma.
Generics are now available for the three therapies: Cystadane, Selzentry, and AmBisome.
This is the first generic available for Revlimid in the United States.
The FDA cited issues related to the compatibility of lenacapavir and the vial used. The agency has not requested new clinical studies.
A total of 28 lots have been recalled because of a high rate of allergic reactions.
Over time, Egaten, an antiparasitic, can increase the QTc interval, resulting in a heart rhythm condition that can cause chaotic heartbeats.
Amneal Pharmaceuticals received approval for Releuko to decrease incidence of infection after chemotherapy.
Once approved, the insulins will be available to patients for no more than $30 per vial.
Vonjo is the first treatment first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis.
The setback for GlaxoSmithKline comes amid a multicompany race to develop a vaccine against respiratory syncytial virus infections.
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