Not enough elderly patients are included in drug trials targeting some of their most common illnesses, a new study by FDA researchers concludes. Source: Drug Industry Daily

The FDA handed Akron Coating & Adhesives a Form 483 for not properly testing or controlling product at its Akron, Ohio, facility. Source: Drug Industry Daily

As part of its commitments for reauthorization of its user fee programs, the FDA today officially launched a new initiative to help sponsors of new drug and biologics products incorporate…

FDA Commissioner Robert Califf warned that the agency’s accelerated approval pathway is in dire need of reform during remarks at the 2022 National Organization for Rare Disorders (NORD) Breakthrough Summit…

An FDA advisory committee recommended 14-1 yesterday that the FDA withdraw accelerated approval for Covis Pharma’s preterm birth drug Makena. Source: Drug Industry Daily

The FDA has updated two compliance program guidances that provide instructions for agency staff conducting inspections, adding provisions for use of alternative inspection tools as well as bringing them into…

Eli Lilly plans to further expand into gene therapies with the $487 million purchase of Massachusetts-based biotech Akouos, a company developing gene treatments for hearing loss. Source: Drug Industry Daily

The FDA has postponed its decision date on Travere Therapeutics’ new drug application (NDA) for sparsentan by three months, pending an update of the drug’s risk evaluation and mitigation strategies…

Ublituximab — TG Therapeutics’ potential blockbuster infusion for multiple sclerosis (MS) — is probably more clinically effective than the approved oral disease-modifying therapies but wouldn’t be cost-effective if priced the…

The European Medicines Agency’s (EMA) human medicines committee gave a thumbs-up to 10 new drugs at its latest monthly meeting. Source: Drug Industry Daily