Regulatory

Pfizer’s talazoparib-enzalutamide combination moves to earlier line in prostate cancer, with eligibility tied to genetic testing and immature survival data.

Bristol Myers Squibb discloses results from it's Phase I Breakfree-2 trial of CAR-T therapy zola-cel for multiple sclerosis.

FDA approved an at-home induction option for risankizumab-rzaa in adults with moderate-to-severe Crohn's disease, based on the phase 3 AFFIRM trial.

The Treasury Department is proposing rules to add biotechnology to its Outbound Investment Security Program under the COINS Act.

Incubate’s John Stanford on why MFN is voluntary in name only — and why the moonshot is the first casualty of drug pricing pressure.

FDA grants Ultomiris accelerated approval for primary immunoglobulin A nephropathy, a pharma funding roundup covers Alcon’s $550 million acquisition of Neurotech and AI Proteins’ collaboration with Astellas, and Incubate’s John Stanford on which therapeutic areas MFN deals might hit hardest.

FDA has granted accelerated approval to Ultomiris based on Phase III data showing a 43.4% placebo-adjusted reduction at 34 weeks.

The FDA approved GSK's bepirovirsen for adults with chronic hepatitis B on nucleoside therapy, based on phase 3 trials showing 19% functional cure.

Incubate’s John Stanford on why MFN’s first casualty is the moonshot — and why cancer, Alzheimer’s, and rare disease bear the cost.

FDA’s conditional approval of Jemperli (dostarlimab-gxly) rests on a single-arm phase 2 trial, with independent-review data still maturing.

Foundayo’s EU backing, Enspryng for TED, Gilead’s masked TCE deal, FDA’s rare disease reset, and Bausch + Lomb’s new interim CEO — explained.

Lilly’s Foundayo receives a positive CHMP opinion for obesity and type 2 diabetes — putting the oral GLP-1 pill on course for EU approval.

The interleukin-6 receptor inhibitor gains a second indication, though one of two phase 3 trials missed its primary endpoint.

European regulators are increasing pressure on clinical trial sponsors to report study results on time, rolling out new monitoring, reminders and guidance as patient advocates welcome the progress but question whether stronger oversight and enforcement will follow.

Fox Rothschild's Mark Wagner on why drug shortages are so hard to fix — from the definition gap to API dependency to three-year site approvals.

FDA is launching the Rare Disease Framework Initiative, aiming to tailor drug development and review requirements to the realities of small patient populations.

Fox Rothschild's Marc Wagner on why scaling drug production is so slow — overseas API sourcing, supplier qualification, and FDA site approvals that take years.

Fox Rothschild's Marc Wagner on why the FDA counts 70 drugs in shortage while ASHP counts 188 — and what's driving the gap.

The FDA approved Tecentriq plus chemotherapy for stage III dMMR colon cancer, Roche’s 12th US indication for the immunotherapy.

Ultragenyx is selling it's Rare Pediatric Disease Priority Review Voucher earned for Genglycos’s approval for $210 million.

A passing FDA inspection tells pharma senior leadership very little about whether the next significant revenue vulnerability is already taking shape. But continuous, AI-enabled quality management maturity (QMM) has the potential to do so months before the issue reaches the realm of P&L.

Tukysa adds a chemotherapy-free maintenance option for HER2-positive metastatic breast cancer; liver toxicity monitoring remains a key consideration.

What North American and APAC sponsors need to know about EU Joint Clinical Assessment — and why EMA approval doesn't guarantee reimbursement.

Trialbee CEO Matt Walz explores the current impact of AI in delivering practical gains in clinical development and reflects on its future potential, where enrollment predictability may be the biggest prize of all.

FDA has expanded Camzyos's approval to treat symptomatic obstructive hypertrophic cardiomyopathy in pediatric patients as young as 12.