Sales of Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab) have been exceedingly low. Source: Drug Industry Daily

The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in 2021 — slightly fewer than 53 approved in 2020. Source: Drug Industry Daily

The FDA has issued nasal-spray maker Amcyte Pharma of Kirkland, Wash., a warning letter for marketing an unapproved and misbranded product related to COVID-19. Source: Drug Industry Daily

An appraisal committee for the UK’s National Institute for Health and Care Evidence (NICE) has recommended against National Health Service (NHS) use of Lynparza (olaparib), AstraZeneca’s blockbuster cancer drug, for…

Sen. Joe Manchin (D-W.Va.) reiterated his opposition yesterday to President Biden’s nearly $2 trillion social spending package, saying there are currently no negotiations underway — further sinking the Build Back…

The FDA has announced that due to the fast-spreading Omicron variant of COVID-19, it will postpone the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in…

Applied Therapeutics got some coal in its stocking last week, when the FDA said the company needs clinical outcomes data, not just biomarker numbers, to support a New Drug Application…

The Centers for Medicare and Medicaid Services (CMS) has formally rescinded a Trump-era policy seeking to tie what Medicare pays for certain outpatient drugs to the lowest price paid by…

In the latest chapter in the 340B Drug Discount Program saga, HHS has appealed decisions issued in three federal courts that called into question the agency’s authority to punish drug…

A federal court has upheld the validity of Novartis’ patent covering a dosing regimen for its blockbuster multiple sclerosis therapy, Gilenya (fingolimod), rejecting a challenge from Chinese drugmaker HEC Pharma.…