Pharmaceuticals
Today is the PDUFA decision date for Moderna's mFlusiva, the first mRNA-based seasonal flu vaccine ever to seek US approval. A unanimous 9-0 advisory panel vote, a 27% efficacy advantage over standard flu shots, and a dramatic regulatory reversal set the stage for a landmark decision.
Pharmaceuticals
Novartis receives FDA approval for Pluvicto in metastatic hormone-sensitive prostate cancer, nearly doubling the eligible patient population and validating radioligand therapy's role earlier in the treatment journey.
Pharmaceuticals
Novo Nordisk's ZEUS trial failure reveals a critical gap in cardiovascular drug development: reducing inflammation doesn't guarantee clinical benefit. What this means for the future of anti-inflammatory therapies.
Biotechnology
On July 30, 2026, an FDA advisory panel voted 10-3 in favor of Replimune's RP1, an oncolytic virus therapy for advanced melanoma. The vote represents a potential turning point after two prior rejections and signals a possible shift in the FDA's approach to single-arm trials in oncology.
Biotechnology
Altimmune's pemvidutide just posted positive Phase 2 data in alcohol use disorder. The result is more than a single trial win. It is the latest signal that GLP-1 biology is expanding into addiction medicine in ways the field is only beginning to understand.
Biotechnology
argenx's $2.2 billion acquisition of Forte Biosciences is more than an immunology M&A deal. It is a strategic bet on CD122 biology and a mechanism that targets the T-cell and NK-cell axis in ways the company's existing portfolio does not.
Pharmaceuticals
Eli Lilly's positive Phase 3 results for retatrutide show 22.6% average weight loss in patients with severe obesity and cardiovascular disease—a level historically associated with bariatric surgery. What the data mean for the future of obesity medicine.
Pharmaceuticals
The FDA's approval of Lytenava formalizes what retina specialists have done off-label for over 20 years. The regulatory hurdle is cleared. The commercial one may prove harder.
Pharmaceuticals
Centanafadine's FDA decision on July 24, 2026 marks a potential breakthrough in ADHD treatment. As the first triple monoamine reuptake inhibitor, it could offer a new option for patients who cannot tolerate stimulants.
Biotechnology
GSK's FDA approval of Jideytro marks more than a drug launch—it signals the arrival of second-generation targeted therapies in oncology with meaningful clinical advantages over first-generation inhibitors.
Biotechnology
Agios Pharmaceuticals discontinues tebapivat in sickle cell disease after Phase 2 data fails to show meaningful differentiation from competitors, removing the company's backup narrative and concentrating risk on mitapivat's November FDA decision.
Policy
The FDA's finalized guidance on psychedelic drug development provides the clearest regulatory roadmap yet for companies developing psilocybin, MDMA, and related compounds as treatments for psychiatric disorders.