Regulatory
The FDA and CDC warned Thursday of a small increased risk of developing Guillain-Barré syndrome in older adults after immunization with respiratory syncytial virus vaccines from GSK and Pfizer.
Despite the approval of two novel therapies for this uniformly fatal neurodegenerative disease, experts say regulatory standards and expectations are still evolving.
The FDA will kick off March with three target action dates, including one for an insomnia treatment and another for a multiple sclerosis therapy.
On Wednesday, the CDC’s Advisory Committee on Immunization Practices voted to recommend Valneva’s chikungunya virus vaccine Ixchiq for certain high-risk patient groups.
This episode explores the drug pricing gap between consumer experience and industry norms. Join Lori and our KOLs as we explore the drivers of healthcare costs, the CBO, rebates, and overall spend in this new series.
Stakeholders Hope Bill Will Create IRA Drug Negotiation Parity Between Biologics and Small Molecules
Congressional legislation seeks to “equalize” the negotiating period between biologics and small molecules under the Inflation Reduction Act’s Drug Price Negotiation Program.
The Canadian biotech’s regulatory setbacks continued on Tuesday with an FDA Refusal to File letter for its intramuscular formulation of the humanized monoclonal antibody Trogarzo.
Amid the dual crises of worsening medicine quality and growing drug shortages, the FDA plans to increase inspections of Indian manufacturing facilities this year, Reuters reported Tuesday.
The FDA has rejected Minerva Neurosciences’ treatment for negative symptoms in schizophrenia, noting a lack of data and other factors that led to the Complete Response Letter.
Despite a patent extension, Merck’s muscle relaxant reversal injection is now facing potential generic competition from Hikma Pharmaceuticals, which is seeking the FDA’s approval for a copycat version.
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