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March 29, 2016
Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.
The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.
March 25, 2016
The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.
March 22, 2016
The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.
The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.
March 15, 2016
Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).
March 11, 2016
Doctors and oncologists agree with pharma companies in opposing the latest proposal from the CMS to revise how it pays for drugs administered in doctors’ offices.
March 10, 2016
The group argues that the so-called “incentives” for physicians to prescribe more costly medications are essentially non-existent following a handful of prior cuts to Medicare Part B reimbursement.
March 09, 2016
The five-year Medicare initiative seeks to change the way in which drugs are reimbursed under Medicare Part B.
March 07, 2016
The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.