FDA

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.

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.

METiS TechBio and Eli Lilly collaborate on next-generation LNP delivery technology, Incubate’s John Stanford on how MFN deals may shape future pharma decisions, and the FDA grants accelerated approval to GSK’s Jemperli for MSI-H/dMMR locally advanced rectal cancer.

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

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

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

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

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

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.

Regeneron and Sanofi expand their antibody alliance with four new drug candidates, FDA approves Camzyos for adolescents with obstructive hypertrophic cardiomyopathy, and Michael Abrams questions digital health's savings claims to employers.

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

Novo Nordisk data show real-world weight loss after switching to its oral semaglutide pill, FDA's peptide rulemaking stalls while its enforcement arm targets compounded peptide sellers, and Avi Pardo flags a compliance blind spot in field teams' text messages with doctors.

New U.S. guidance exempts orphan drugs, nuclear medicines, cell and gene therapies, and other specialty products from the 100% pharmaceutical tariff when imported from 19 named countries.

While the FDA weighs a narrow, regulated path for compounded peptides, its enforcement arm is already taking action.

FDA this week cleared three new treatments: Lilly's Olumiant for adolescent alopecia areata, AbbVie's Juvmo for Parkinson's disease, and Mirum and Incyte's Atebrioz for the rare bone disorder FOP.

FDA approves Merck and Eisai's Welireg-Lenvima combination for advanced kidney cancer, a platform-deal roundup covers Novo Nordisk, Genentech, and Roche's tie-ups with Nanexa, Earendil Labs, and Atavistik Bio, and Ron Lanton examines the fight to regulate pharmacy benefit managers.

FDA has approved Welireg plus Lenvima for previously treated advanced clear cell renal cell carcinoma.

InnoCare Pharma and Eli Lilly ink a multibillion-dollar research collaboration, FDA approves Lilly's once-weekly insulin Onswik for type 2 diabetes, and Jen Lamppa talks fixing clinical trial patient enrollment with real-world data.

FDA approves Onswik, Eli Lilly's once-weekly basal insulin for adults with type 2 diabetes.

FDA approves Ultragenyx's Fayuvi as the first treatment for Sanfilippo syndrome type A, Lisata Therapeutics acquires Marea Therapeutics as mAbxience partners with Sandoz on a hemophilia A biosimilar, and Joe Cunningham argues that executive drug-pricing deals alone won't fix costs.

FDA approved Ultragenyx's Fayuvi (rebisufligene etisparvovec-hopf) as the first treatment for MPS IIIA Sanfilippo syndrome type A.

FDA approves Kerendia as the first new treatment for kidney disease in type 1 diabetes in decades, Novo, Roche, and Aethlon Medical strike major deals and mergers with Orbis Medicines, Dualitas Therapeutics, and North Immunology, and Thani Jambulingam of Saint Joseph's University examines the fight to control the GLP-1 patient journey.

FDA has approved Bayer's Kerendia to reduce disease progression risk in adults with chronic kidney disease associated with type 1 diabetes.