Soon after FDA warned about a potential increased risk of foot and leg amputations with the use of the type 2 diabetes medication canagliflozin (Invokana and Invokamet, Janssen Biotech), the agency strengthened the existing warning about the risk of acute kidney injury with Invokana and Invokamet, as well as dapagliflozin (Farxiga and Xigduo XR, AstraZeneca).
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 serious burns with the use of the patch.
FDA approved the first US vaccine for cholera, Vaxchora, made by PaxVax Bermuda Ltd. in Hamilton, Bermuda. Vaxchora is the only single-dose vaccine for cholera currently licensed anywhere in the world.
FDA is warning consumers about the risk of serious bleeding when using over-the-counter aspirin-containing antacid products to treat heartburn. The agency also issued a separate warning about loperamide (Imodium, Johnson & Johnson), saying that abuse or misuse of the product can cause serious heart problems that can lead to death.
The first and only fixed-dose combination of a beta blocker beta blocker (BB) and angiotensin II receptor blocker (ARB) for hypertension will be available in the US in the second half of the year. FDA approved nebivolol and valsartan (Byvalson, Allergan) 5 mg/80 mg tablets in early June.
FDA recently approved daclizumab (Zinbryta, Biogen and AbbVie), a once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS).
The global oncology market was worth $107 billion in 2015, and global annual cancer drug costs surged by 11.5% from 2011 to 2015, according to a new report.
FDA recently approved the first 4-strain, cell culture-derived, inactivated seasonal flu vaccine available in the United States. Flucelvax Quadrivalent influenza vaccine (Seqirus) helps protect against the 2 influenza A viruses and two B viruses recommended by the World Health Organization (WHO) and the FDA for the current influenza season.
In a major new entry in the diabetes market, FDA just approved linagliptin and metformin hydrochloride extended-release tablets (Jentadueto XR, Boehringer Ingelheim and Eli Lilly and Company) to treat type 2 diabetes.
Novo Nordisk’s new diabetes drug production facility in Clayton, N.C., will ensure production capacity for these drugs in the United States for the decade ahead.
A systemic review highlights studies that improved medication adherence and patient outcomes using strategies that could be effective if employed in real-world healthcare settings.
FDA recently granted accelerated approval for atezolizumab (Tecentriq, Genentech), the first drug for bladder cancer that utilizes the body’s immune system. The drug will be available by early June.
FDA has approved lenvatinib (Lenvima, Eisai Inc.) in combination with everolimus for the treatment of advanced renal cell carcinoma.
In alarming news for diabetic patients taking canagliflozin (Invokana, Invokamet) medications, FDA is warning that interim safety results from an ongoing clinical trial found an increase in foot and leg amputations with the drugs.
Nivolumab (Opdivo, Bristol-Myers Squibb) received two new approvals from FDA to treat two different cancers.
After heavy criticism by Congress, presidential candidates and others, Valeant Pharmaceuticals is offering a discount program on its heart drugs Nitropress and Isuprel.
There's a growing need for improved access to medication-assisted treatment among patients with opioid use disorder, according to a new study presented at the American Society of Addiction Medicine 47th Annual Conference.
If a proposed Vermont bill is successful, drug companies would have to explain why they hiked prices on certain drugs.
FDA issued a new warning about potentially serious side effects associated with fluoroquinolone antibacterial drugs. Affected brands include Cipro, Levaquin, Avelox, Factive and Moxaflaxacin injection, as well as the generic Ofloxacin.
FDA is warning that the antipsychotic medicine olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body.
FDA recently fast-tracked approval of cabozantinib (Cabometyx, Exelixis, Inc.) to treat advanced renal cell carcinoma. Here are the top 5 facts to know about Cabometyx.
Express Scripts will implement more programs that pay for drugs based on their effectiveness, according to the PBM’s chief medical officer Steve Miller, MD. Simultaneously, the PBM plans to implement a spending cap on diabetes medications.
FDA approved the first drug to hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.
The first US test for the Zika virus is available after Quest Diagnostics received an Emergency Use Authorization (EUA) for its Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test).
FDA recently approved a new indication for afatinib (Gilotrif, Boehringer Ingelheim) for patients with squamous cell carcinoma of the lung. The once-daily tablets are now indicated for the treatment of patients with the lung cancer, whose disease has progressed after treatment with platinum-based chemotherapy. Here are the top 6 facts to know about Gilotrif.
FDA expanded the use of ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets without ribavirin (Viekira Pak, AbbVie) this week to treat patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A).
Surprisingly, Medicare beneficiaries are likely to pay much more for biosimilars than the referenced brand medication, according to a new report.
The generic metformin (Mallinkrodt) significantly reduced the risk of dying from heart attack and stroke compared to other common diabetes medications, according to a new study.
