The FDA’s approval process has garnered many criticisms over the years. For one, generic drugs and devices often make it to market simply because the manufacturers can demonstrate they are similar to products that were approved in the past — even if those products have known safety concerns....
In 2000, one year after the FDA approvedVioxx, a clinical trial identified numerous heart risks associated with the drug, but drug maker Merck downplayed Vioxx’s dangers. In a congressional investigation into how Merck and the FDA handled the Vioxx recall, documents revealed that Merck knew abo...
She sued the drug-maker, Wyeth, because (she claimed) its FDA-approved label did not contain adequate warnings about the danger of injecting near an artery. In lower courts, she was awarded several millions in damages, but Wyeth appealed, stating its belief the FDA-mandated label required no...
We highly expect to see more ADC approvals in the not-so-distant future, whether they be in the form of new ADCs, or label expansions of those already approved. Arguably, the lack of variety in the MoA for payloads, linker type, and an avoidance of engineered antibodies to improve DAR...
Approved:May 19 Companies:AbbVie and Genmab The scoop:After an approval in May, Epkinly is going toe-to-toe with Roche’s Columvi in large B-cell lymphoma. Epkinly not onlyarrivedabout a month earlier than its rival, but it also boasts a broader label. Compared with Colum...
The FDA's approved label for Paxlovid is limited to treating infected "adults who are at high risk for progression to severe COVID-19." Doctors typically have the freedom to prescribe fully approved drugs "off-label" for other reasons to their patients, beyond the FDA's approval. But bec...
The Food and Drug Administration approved a request by Eli Lilly on Wednesday to begin marketing its tirzepatide medication, which is branded as Mounjaro for diabetes, under a new brand for weight loss as well. While Mounjaro had already been used by some patients "off-label" for weight lo...
Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but ...
manufacturer has voluntarily withdrawn their marketing application, generics that reference the brand medicine can still be approved and marketed. But the brand drug manufacturer is no longer responsible for making any necessary label updates that generic applicants can follow. This means that some d...
Off-label uses don't always stay off-label. For example, in the past, beta-blockers were often prescribed off-label for heart failure, but now, with more studies completed, several are approved for that use. Off-label prescribing is especially common if you have a rare health issue and ...