Policy
Following the FDA’s approval last month, a Centers for Disease Control and Prevention panel has recommended AstraZeneca’s and Sanofi’s Beyfortus for immunizing infants and high-risk young children.
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Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
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Following the Supreme Court’s decision to overturn Roe v. Wade, abortion rights activists are calling for the FDA to consider making abortion medication Mifeprex an over-the-counter option for patients.
The FDA lifted its clinical hold on Vertex Pharmaceuticals’ Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID).
Provention Bio announced the FDA extended its review period by three months for the Biologics License Application (BLA) of its diabetes prevention drug, teplizumab to Nov. 17.
Citing an unnamed FDA insider, the regulator is in the process of devising a plan to enable clinical testing on a larger scale.
Companies are still developing and refining treatments and preventions for COVID-19, but not all of them are approved or authorized. Here’s a look at the latest COVID-19 news.
There’s quite a bit of movement on the Omicron-specific booster shot and updated supply deals, despite world leaders shifting their attention away from the COVID-19 pandemic.
The FDA’s decision came after researchers found cases of drug-induced liver injury in some patients. Tolebrutinib is being evaluated for relapsing types of MS, MG, nrSPMS, and PPMS.
As the nation reacts to the overturning of Roe v. Wade, pharma companies must address the changes in demand for drugs and services, all while navigating increasingly muddy legal waters.
Voting 19-2, the Vaccines and Related Biological Products Advisory Committee favored redesigning booster shots to include the coronavirus’ Omicron variant.
Spero Therapeutics received a Complete Response Letter from the U.S. Food and Drug Administration for its complicated urinary tract infection therapy, tebipenem HBr oral tablets.