UPLIZNA Offers gMG Patients Deep and Durable Symptom Control and Twice-Yearly Dosing* First and Only CD19-Targeted B Cell Therapy Approved in anti-AChR and anti-MuSK ...

More recently, the FDA posted two two letters: one backdated for September 9, regarding GSK’s HIV medication Apretude and one ...

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading ...

" It sounds wholesome, right? Pure. Like something your grandmother might have used in her kitchen. The clean label movement has exploded in recent years, with half of industry professionals ...

The drugs have soared in popularity, with some men taking them for unapproved uses like anti-aging or increasing muscle mass.

Promo materials should also refrain from positioning one approved biosimilar as better than another for the same reference ...

Groups representing major companies, including Kraft Heinz and Coca-Cola, argue the law misleads consumers and violates the ...

Simplifying nutrition information can empower consumers to make healthier, more informed dietary choices and reduce their risk of cardiovascular disease (CVD), according to guidance issued by the ...

Approval is based on results from the BRUIN CLL-321 trial, the only randomized Phase 3 study in CLL/SLL in which all patients were previously treated with ...

Tarlatamab-dlle received FDA approval for ES-SCLC after showing a 40% reduction in death risk compared with chemotherapy in the DeLLphi-304 trial. The trial demonstrated improved overall survival ...

Hormone therapies for menopause will no longer carry a black box warning about serious risks such as breast cancer, heart attack and stroke, the Food and Drug Administration announced Monday. In the ...

Studies in the early 2000s claimed there were major risks associated with HRT. The Food and Drug Administration said Monday it will remove the "black box" warning from hormone replacement therapy (HRT ...