FDA/Regulatory – PharmaLive

The European Medicines Agency announced on Friday that it has found no causal association between GLP-1 receptor agonists—a popular class of weight-loss treatments that include Novo Nordisk’s...

https://www.pharmalive.com/ema-finds-no-link-between-glp-1-drugs-and-suicidal-thoughts-self-harm/

A Florida judge on Tuesday dismissed Eli Lilly’s case against a compounding pharmacy, finding that the drugmaker cannot use state law in its campaign against reformulated versions of the compan...

https://www.pharmalive.com/lilly-suffers-legal-loss-in-tirzepatide-case-against-compounding-pharmacy/

The FDA on Thursday greenlit the label expansion of AstraZeneca’s subcutaneous IL-5 receptor blocker Fasenra (benralizumab), which can now be used as an add-on maintenance treatment for severe ...

https://www.pharmalive.com/astrazeneca-expands-fasenras-label-to-younger-children-with-severe-asthma/

The U.S. Department of Justice announced Wednesday it has filed a False Claims Act complaint against Regeneron Pharmaceuticals, alleging that the company “fraudulently inflated Medicare reimbur...

https://www.pharmalive.com/doj-sues-regeneron-for-allegedly-inflating-medicare-pricing-for-eye-drug-eylea/

Nigeria's health regulator is recalling a batch of Johnson & Johnson children's cough syrup after finding an unacceptably high level of a potentially fatal toxic substance, it said on Wednesday. ...

https://www.pharmalive.com/nigeria-recalls-jj-childrens-cough-syrup-over-toxic-substance/

Nearly 7 million low-income women and children will be able to purchase more fruits and vegetables but less dairy after the U.S. Department of Agriculture finalized changes to a key federal nutri...

https://www.pharmalive.com/more-produce-less-dairy-for-low-income-families-under-u-s-nutrition-program-changes/

The European Medicines Agency is set to review several diabetes and weight-loss treatments this week in connection with potential increased risk of suicidal ideation and self-harm, according to a...

https://www.pharmalive.com/ema-to-review-diabetes-and-weight-loss-drugs-for-suicidal-ideation-risk/

Supernus Pharmaceuticals said on Monday the U.S. FDA declined to approve its drug-device combination to treat movement-related symptoms of Parkinson's disease, sending its shares down 9% in early...

https://www.pharmalive.com/u-s-fda-declines-to-approve-supernus-parkinsons-combination-again/

The FDA on Friday approved AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of HER2-positive solid tumors in adults who have ...

https://www.pharmalive.com/astrazeneca-daiichi-sankyo-win-first-tumor-agnostic-her2-fda-approval-for-enhertu/

The FDA on Tuesday approved the use of Vanda Pharmaceuticals’ atypical antipsychotic Fanapt (iloperidone) for the treatment of manic or mixed episodes in adult patients with bipolar I disorder....

https://www.pharmalive.com/vanda-gets-fda-approval-for-fanapt-antipsychotic-expands-into-bipolar-disorder/