The manufacturer of eye drops linked to more than 80 adverse reactions, including 14 cases of blindness and four deaths, received a 15-page FDA warning letter calling the company out…
IQVIA, the global contract research organization juggernaut, has filed its opposition to the FTC’s proposed preliminary injunction halting its acquisition of Propel Media, the latest in its back and forth…
Cisplatin, a commonly used chemotherapy drug prescribed to treat several advanced forms of cancer, is again under production by Accord Healthcare, the FDA said Monday. Source: Drug Industry Daily
Bayer is issuing a voluntary withdrawal of Aliqopa (copanlisib) after the PI3K inhibitor failed to meet the primary endpoint of progression-free survival in its postmarketing confirmatory trial. Source: Drug Industry…
Our health care delivery system is changing every day. New medicines, innovative research, new reimbursement policies, doctors burning out and retiring, telemedicine, emergency room delays — these and other changes…
Stolen defective laryngoscopes offered for sale on Facebook Marketplace are now part of a manufacturer recall the FDA has deemed as class I, the most serious type of recall as…
An FDA draft guidance on reporting manufacturing changes in cellular and genetic therapy (CGT) products puts too much emphasis on clinical trials and neglects the benefits and efficacy of bridging…
At first, the idea of repurposing a drug seems so logical. A reasonable person could be forgiven for thinking this is already common practice. Since safety and efficacy have been…
In this edition of Quick Notes, we review recent FDA drug approvals of Zepbound for weight loss, Fruzaqla for colorectal cancer, Cosentyx for hidradenitis suppurativa, Keytruda for biliary cancer, and…
After 19 pilot programs conducted with medical device companies, regulators and patient communities, CDRH’s revised CAPA process is showing a 60 percent closure rate in under 60 days and a…