FDA is reviewing Hemispherx’s reanalysis of data from its Ampligen Phase III trial to determine if an additional confirmatory study is necessary.
Hemispherx Biopharma Inc. may not have to do an additional confirmatory Phase III trial to gain FDA approval of its chronic fatigue syndrome drug Ampligen (rintatolimod), the company announced July 11.
According to the company, FDA has agreed to review new analyses of the AMP-516 Phase III trial supporting its NDA....
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.
With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
