Phase III
Data from a Phase III trial of apraglutide for a type of short bowel syndrome with intestinal failure is expected by the end of the year. It is also in a Phase II study for acute graft-versus-host disease.
Sanofi and Regeneron reported positive results for the anti-inflammatory drug in a chronic obstructive pulmonary disease trial. The companies hope to see approval before a 2024 read-out of a second trial.
In a 12-2 vote with two abstentions, the advisers said the benefits did not outweigh the risks.
The Phase III trial met its primary endpoint, a significant reduction of phenylalanine levels in the blood, with no severe adverse events reported, PTC Therapeutics reported Wednesday.
Veozah, an oral once-daily medication, is the first FDA-approved NK3 receptor antagonist for hot flashes, a common symptom of menopause that can affect health and quality of life.
Preliminary trial results show the GSK five-in-one meningitis vaccine is immunologically effective against the most common strains, as the FDA decision date for Pfizer’s candidate looms.
Nirsevimab lowered hospitalizations due to RSV-related lower respiratory tract disease by 83.21%. Friday’s data drop comes ahead of next week’s advisory committee meeting for Pfizer’s RSV hopeful.
The FDA has four events lined up this week, including a target action date for Krystal Biotech’s gene therapy for a rare skin disease and an adcomm meeting for Pfizer’s RSV vaccine candidate.
Developers of psychedelics-based therapies say the industry is poised to explode, with several reporting strong clinical trial results and the FDA granting breakthrough status for two hallucinogenic drugs.
After a brief slump, interest in ADCs is at an all-time high, highlighted by a handful of recent multi-million- and billion-dollar acquisitions.
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