USA – FDA Warns of Dosing Errors With Compounded Injectables
The US Food and Drug Administration (FDA) last week warned that differences in how drugmakers and compounders label the strength of injectable drugs may...
USA – Clinical Trials: FDA Releases Two Draft Guidances
The US Food and Drug Administration (FDA) on Friday unveiled two draft guidances focused on adaptive clinical trial designs and master protocols for cancer...
USA – US green light for Pfizer’s lung cancer drug
The drug has been cleared under the brand name Vizimpro as a first-line treatment of patients with locally advanced or metastatic non-small cell lung...
USA – US approves AZ’ hairy cell leukaemia drug
The decision allows physicians to prescribe the drug for patients with relapsed or refractory HCL who have received at least two prior systemic therapies,...
USA – FDA awards another non-opioid pain drug breakthrough status
The US regulator yesterday awarded Concentric Analgesics and its pipeline drug CA-008 in post-surgical pain with an FDA Breakthrough Therapy designation (BTD).
Concentric specialises in...
USA – AstraZeneca, Amgen’s tezepelumab wins ‘breakthrough’ status
The therapy is being developed for use in patients who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.
The...
USA – FDA approves new dosage strength of buprenorphine and naloxone sublingual film as...
The U.S. Food and Drug Administration today approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid...
USA – FDA on Pace for Record Generic Approvals in 2018
With two months of data outstanding, the US Food and Drug Administration (FDA) is on pace to approve a record number of abbreviated new...
USA – Roche, Novo Nordisk and Merck Weigh in on FDA Draft Guidance on...
Companies took issue with specific elements of the draft guidance advising sponsors on the premarketing assessment of a drug’s effect on blood pressure.
Roche/Genentech explained,...
USA – Drug Prices in Ads: Senate Passes Amendment
The Senate spending bill passed Thursday and with it an amendment from Sens. Richard Durbin (D-IL) and Chuck Grassley (R-IA) to require prescription drug...
