The agency has removed the hold placed on the pharmaceutical company’s IND for injectable lenacapavir, which is intended for HIV treatment and prevention.
The US agency has expanded its approval of Veklury to include use in pediatric patients 28 days and older who have tested positive for the COVID-19 virus.
The CDMO has been awarded funding from the US government to work on treatments for sarin and other substances used frequently employed in chemical attacks.
Life science investor group, Novo Holdings, has agreed to buy Ritedose, the largest sterile CDMO in the US focused on advanced blow-fill-seal technology, from Hong-Kong based, AGIC Capital, and China’s Humanwell.
The pharmaceutical company has announced GMP-related challenges with a manufacturer contracted to fill syringes for Wegovy pens headed to the US market.
Stevanato Group is showcasing its SG Alina disposable, variable-dose pen injector platform, available with customizable features, at CPhI Worldwide 2021.
The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.
Nucala, a monoclonal antibody indicated for patients with chronic rhinosinusitis with nasal polyps, has been approved by the Food and Drug Administration.