Experimental lung cancer drug promising
AstraZeneca recently released positive new data on its experimental non-small cell lung cancer (NSCLC) drug, AZD9291 (osimertinib). Related: Pharmacy companies underinvest in cancer drugs The data was...
View ArticleFDA approves new treatment for pancreatic cancer
FDA approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated...
View ArticleFirst nasal spray helps with drug overdoses
It will now be easier for non-medical professionals to treat opioid overdoses, after FDA quickly approved Narcan nasal spray last week. Related: [BLOG]: Pain management: Can we balance patient access,...
View ArticleOpdivo approved for patients with metastatic renal cell carcinoma
FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients with metastatic renal cell carcinoma. Renal cell carcinoma is the most common form of kidney cancer in adults and...
View ArticleJ&J’s antibiotic faces $800M lawsuit
A new $800 million racketeering lawsuit alleges that Johnson & Johnson hid information about the devastating side effects of its antibiotic, Levaquin (Levofloxacin). Plus, an FDA panel said last...
View Article5 facts to know about the new asthma drug
FDA recently approved reslizumab (Cinqair, Teva Pharmaceuticals), an injectable used with other asthma medicines for the maintenance treatment of severe asthma. Cinqair is approved for patients who...
View ArticleControversy surrounds abortion pill access
Soon after FDA expanded access to the “abortion pill” or mifepristone (Mifeprex, Danco Laboratories), some states may be combating the decision. FDA recently expanded Mifeprex, in a regimen with...
View ArticleNew hypertension drug gets FDA approval
The first and only fixed-dose combination of a beta blocker (BB) and angiotensin II receptor blocker (ARB) for hypertension will be available in the United States in the second half of the year. FDA...
View ArticleTeva halts migraine patch sales over burns
Teva Pharmaceuticals is temporarily suspending sales and distribution of its sumatriptan iontophoretic transdermal system (Zecuity) patch for migraines, after FDA said it is investigating the risk of...
View ArticleFDA approves first treatment for acute GVHD
FDA granted breakthrough therapy designation to ruxolitinib (Jakafi, Incyte Corp.) as the first treatment for acute graft-versus-host disease (GVHD). Related: FDA approves are liver disease drug GVHD...
View ArticleZika vaccine on the horizon
The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) plans to help bring a vaccine for the Zika virus to market immediately via...
View ArticleGame-changing depression drug on horizon
FDA recently granted breakthrough therapy designation for esketamine (Janssen Research & Development), an investigational medication to treat major depressive disorder with imminent risk for...
View ArticleNew drug approved for heart patients
FDA approved a fixed-dose combination of aspirin, an antiplatelet agent, and omeprazole, a proton pump inhibitor (Yosprala, Aralez), for patients who require aspirin for secondary prevention of...
View ArticleBig savings expected with new generic antipsychotic
FDA tentatively approved the abbreviated new drug application (ANDA) for generic quetiapine fumarate extended-release tablets (brand Seroquel XR, AstraZeneca) to treat schizophrenia and manic/mixed...
View ArticleLung cancer drug approved
Soon after FDA granted accelerated approval for atezolizumab (Tecentriq, Genentech) to treat bladder cancer, the agency apporoved the drug to treat metastatic non-small cell lung cancer (NSCLC). This...
View ArticleAdvanced ovarian cancer drug approved
FDA recently approved rucaparib (Rubraca, Clovis Oncology) tablets to treat patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer, who have been treated...
View ArticleNew bladder cancer, kidney disease therapies available
FDA recently approved 2 new therapies: an expanded drug indication for locally advanced or metastatic urothelial carcinoma (mUC) and a treatment for secondary hyperparathyroidism (HPT) in adult...
View ArticleTests help aid in antibiotic control
FDA recently approved 2 tests that will aid healthcare providers in determining which antibiotics are needed, leading to better antibiotics management. FDA approved the PhenoTest BC Kit, performed on...
View ArticleGeneric versions of major depression drug available
Mylan received approval from FDA to market its desvenlafaxine extended-release (ER) tablets, the generic version of Pristiq (Pfizer), for major depressive disorder. Plus, 2 other manufacturers recently...
View ArticleFDA clears second Remicade biosimilar
In what is expected to produce hefty savings for rheumatoid arthritis (RA) patients and the healthcare system, FDA approved the second biosimilar to Remicade (Johnson & Johnson).Samsung Bioepis...
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