Regulatory
The complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve Lumryz.
FDA Weekly Review looks at the FDA’s actions related to drug approvals, IND approvals, designations and more. Here’s a look at what happened this week.
Sandoz hopes its high-concentration formulation of an already greenlit biosimilar will be approved by the time AbbVie’s blockbuster drug Humira loses patent protection in the United States.
In what it is calling a strategic decision, Sesen Bio announced Monday that it has paused development activities of Vicineum, its lead asset, in the United States.
Mid-July is a relatively quiet time for the FDA in terms of drug approvals, but Incyte and Arcutis will have all eyes on the regulator as they await decisions in vitiligo and psoriasis.
Omega Therapeutics announced Thursday that the Investigational New Drug (IND) application for its hepatocellular carcinoma (HCC) candidate OTX-2002 has been granted by the FDA.
Clene, Inc. released data that shows its add-on treatment, CNM-Au8, significantly improved survival in patients with amyotrophic lateral sclerosis (ALS) by 70%.
CytoDyn Inc. has tapped Cyrus Arman as its new president and he is expected to take over the reins of the company as chief executive officer and be added to the board of directors within six months.
The FDA granted Novavax’s COVID-19 vaccine Emergency Use Authorization after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older.
Aldeyra Therapeutics announced results from a crossover clinical trial, showing that its drug candidate reproxalap was effective in improving ocular redness and tear production in patients with dry eye disease.
PRESS RELEASES