FDA

The FDA has approved Ibrance (palbociclib) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.

In today's Pharmaceutical Executive Daily, an FDA advisory committee votes unanimously in favor of the benefit-risk profile of Moderna's investigational mRNA-1010 seasonal influenza vaccine across both younger and older adult populations, a pharma funding roundup covers Kardigan's upsized $400 million IPO debut on Nasdaq and cAMPfield Therapeutics' $180 million Series A launch, and Pharmaceutical Executive speaks with Brian Hilberdink of Boehringer Ingelheim on redefining what success looks like in obesity care in the GLP-1 era.

FDA advisory panel voted 9-0 to recommend approval of Moderna's mRNA flu vaccine mRNA-1010 across both the 50-to-64 and 65-and-older age groups, a unanimous outcome that validates the underlying clinical data.

In today's Pharmaceutical Executive Daily, Biogen announces its second acquisition of 2026, a deal worth up to $1 billion for private immunology biotech RayThera, FDA approves Utebzi as the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections, and FDA expands the indication for Merck's Capvaxive to include children and adolescents aged 2 through 17 with chronic medical conditions at increased risk for pneumococcal disease.

FDA has expanded Capvaxive's indication to high-risk children and adolescents aged 2 through 17 who have completed a primary pneumococcal series, making it the only conjugate vaccine in the U.S. specifically studied and approved for this population.

FDA has approved Utebzi as the first oral carbapenem antibiotic for complicated urinary tract infections, giving patients and providers an alternative to intravenous-only carbapenem therapy.

In today's Pharmaceutical Executive Daily, FDA staff release briefing documents flagging evidence gaps in Moderna's mRNA flu vaccine, a pharma roundup covers Merck's $510 million collaboration with Protillion Biosciences and Jazz Pharmaceuticals' multi-program antibody discovery deal with AbCellera, and Jack McFeely argues that behavioral and engagement insights are the missing ingredient in patient support programs that struggle to sustain long-term persistence.

FDA scientists have flagged evidence gaps in Moderna's mRNA flu vaccine mFlusiva ahead of an advisory committee vote, raising questions about its performance across influenza strains, high-risk patient subgroups, and co-administration scenarios.

FDA has approved Skinvive by Juvéderm as the first hyaluronic acid injectable specifically indicated for neck wrinkles, expanding the Allergan Aesthetics franchise into a new anatomical area.

In today's Pharmaceutical Executive Daily, Boehringer Ingelheim's Brian Hilberdink argues that obesity innovation must evolve beyond the scale, a pharma regulatory roundup covers two significant FDA approvals, and Pharmaceutical Executive speaks with Raj Indupuri, CEO of eClinical Solutions, on making the ROI case for smarter clinical trials in an era of exploding trial data complexity.

FDA approved two targeted combination regimens this week, clearing AstraZeneca's Truqap as the first biomarker-directed therapy for PTEN-deficient prostate cancer and Merck's Keytruda and Keytruday Qlex plus Welireg.

Jazz Pharmaceuticals' Zepzelca failed to improve overall survival in the Phase III Lagoon confirmatory trial for second-line small cell lung cancer, putting its accelerated approval in that setting at risk.

Eli Lilly and Company notes that the approval of an every-8-week maintenance dose of lebrikizumab offers sustained atopic dermatitis control with fewer annual injections.

FDA has accepted Roche's NDA for giredestrant under Priority Review, moving the investigational oral SERD closer to potential approval .

FDA has issued a Complete Response Letter to Cingulate’s ADHD candidate CTx-1301 over manufacturing-related deficiencies, delaying approval of the once-daily therapy while leaving its clinical safety and efficacy profile unchallenged.

FDA approves Shionogi’s Xocova as First Oral Post-Exposure Covid-19 Prevention Therapy, marking a major milestone for Covid-19 prevention treatments.

In today’s Pharmaceutical Executive Daily, Harpreet Singh discusses the evolving regulatory landscape for biopharma, the World Health Organization identifies three priority treatment candidates for the Bundibugyo strain of Ebola virus disease, and this week’s pharma roundup highlights new findings on Mounjaro and long COVID-related immune system changes.

FDA advisors are set to meet this week to determine whether Covid-19 vaccines should be updated to target the emerging XFG variant, a decision that could shape the composition of the 2026–2027 immunization season amid ongoing viral evolution.

Harpreet Singh, former FDA Oncology Division Director and current chief medical officer at Precision for Medicine notes how evolving FDA review standards, expedited approval programs, and emerging AI tools are reshaping the regulatory landscape for biopharma companies.

Harpreet Singh, MD, notes that FDA’s internal AI system could improve efficiency in drug review by helping reviewers aggregate and synthesize complex data.

In today’s Pharmaceutical Executive Daily, Eli Lilly announces three acquisitions totaling roughly $3 billion, the FDA approves Hepcludex as the first treatment for chronic hepatitis delta virus infection in the United States, and biotech finance leaders reflect on the lessons learned from navigating two decades of volatile markets.

FDA approves Gilead’s Hepcludex as the first treatment for chronic hepatitis delta virus in the U.S., marking a major milestone for a severe liver disease with limited therapeutic options.

FDA approves AstraZeneca and Daiichi Sankyo’s Datroway for first-line metastatic triple-negative breast cancer, expanding treatment options for patients ineligible for PD-1/PD-L1 inhibitor therapy.

Harpreet Singh, MD, notes that the FDA’s broader shift toward accepting single pivotal trials reflects an evolution in regulatory thinking, while noting the agency still weighs disease severity, unmet need, trial design, and long-term safety

Harpreet Singh, MD, says understanding regulatory precedent, division-level dynamics, and the agency’s data-driven culture is critical for biopharma sponsors navigating today’s oncology approval landscape.