Industry News

The new drug may help vulnerable children resist RSV in the coming fall and winter season.

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

Westlake’s third fund of $450 million will be used to grow early stage biotechnology companies.

Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.

FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.

UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.

The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.

The prestigious award, worth €20,000 (US$22,000), goes to Maurice Michel of the Science for Life Laboratory at Karolinska Institutet, Stockholm, Sweden.

The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

FDA’s new voluntary pilot program is designed to help clinicians select appropriate cancer treatments for patients.

There is concern that debates will delay the five-year reauthorization of PEPFAR under review by Congress.

World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration.

The complaint alleges that Medicaid price controls implemented in the Inflation Reduction Act will negatively impact biopharmaceutical innovation.

The document builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.

Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.

FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products.

The project is being coordinated by the recently formed not-for-profit CCRM Nordic AB and gathers engaged stakeholders to move the initiative forward.

The next Cannabis Science Conference Fall meeting is soliciting a call for abstracts.

The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.

FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.

FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.

Biotech firm Lumen Bioscience has received fast track designation from FDA for its oral biologic drug candidate for treating C. difficile infection.