The FDA has approved AstraZeneca’s anifrolumab for adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. This is the first new approval for these patients in 10 years, and just the second in the past 60 years. Para acessar a publicação na íntegra clique aqui Fonte: 658 | SEPTEMBER 2021 | volume 20 NEwS in BRiEf www.nature.com/nrd…
Drug pipeline 2Q21—accelerated approvals to the fore
Accelerated, rather than full, approvals were prominent. As usual, cancer registrations predominated—including Amgen’s Lumakras, a first-in-class covalent targeter of KRAS in lung cancer. The other big news was the controversial go-ahead from the US Food and Drug Administration (FDA) for Biogen’s Alzheimer’s monoclonal antibody (mAb) Aduhelm, which later was given a narrower label by the agency; the approval prompted calls by the acting FDA head for a federal investigation into interactions between the drug developer and regulators. Para acessar a publicação na íntegra…
FDA new drug approvals in Q2 2021
Among the 13 FDA approvals during the second quarter of 2021, one has undoubtedly been the biggest talking point. Biogen’s Alzheimer disease drug Aduhelm (aducanumab) has become one of the most controversial authorizations for some time, with much debate about whether the FDA… Para acessar a publicação na íntegra clique aqui Fonte: 578 | August 2021 | volume 20 www.nature.com/nrd…