Patient Access

An FDA advisory panel voted narrowly to recommend four unapproved peptides, BPC-157, KPV, TB-500, and MOTS-c.

In today's Pharmaceutical Executive Daily, FDA grants emergency use authorization for Seegene's multiplex PCR assay, a Pfizer medical lead makes the case for continued antiviral use among Covid-19 high-risk patients, and Nuvation Bio's CEO discusses the company's oncology pipeline and philosophy of developing better drugs rather than more of them.

FDA has granted Emergency Use Authorization to Seegene USA's Allplex multiplex PCR assay, making it the first U.S.-authorized test to simultaneously detect and differentiate HSV-1, HSV-2, VZV, and monkeypox virus in a single reaction.

Dr. Gurinder S. Sidhu, senior medical director and U.S. Antiviral Medical Lead, Pfizer, discusses how Covid-19 remains a serious threat to the roughly 75% of American adults who qualify as high-risk, and pushes back against clinician complacency.

Robert Allen, Ph.D., Chief Scientific Officer, outlines how the company's Invymab platform uses viral surveillance and predictive modeling to design monoclonal antibodies against likely future variants rather than current strains.

FDA has converted Fabhalta's accelerated approval to a traditional approval for IgA nephropathy after confirmatory Phase III data showed the oral complement inhibitor slowed annual kidney function decline.

FDA has approved Merck's Lipfendra as the first oral PCSK9 inhibitor, giving patients with high LDL cholesterol a once-daily pill alternative to injectable therapies.

FDA has approved Celcuity's Revtorpyk as the first pan-PI3K and mTORC1/2 inhibitor, clearing it for HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation.

FDA has approved a subcutaneous formulation of Leqembi, giving early Alzheimer's patients the option to self-administer the anti-amyloid therapy at home via weekly autoinjector.

FDA has approved Sarclisa Escena as the first anticancer treatment administered via an on-body injector, offering multiple myeloma patients and providers a subcutaneous alternative to time-intensive IV infusions across all three of isatuximab's existing indications.

Empower Pharmacy founder and CEO Shaun Noorian argues that declining patient engagement across demographics is a failure of system design not patient behavior.

Novo Nordisk has launched the Medicare GLP-1 Bridge, making Wegovy available to eligible Medicare beneficiaries for $50 a month through the end of 2027, giving millions of older adults with obesity a structured pathway to the FDA-approved weight management drug.

Once a niche pilot, direct-to-patient drug distribution is now a defining strategic priority, with manufacturers building the right infrastructure standing to capture margin, data, and patient relationships that used to belong to intermediaries.

Consolidation, specialty growth, and integrated networks are multiplying the entities manufacturers must classify, just as the IRA, 340B, and Medicaid rules raise the cost of getting any one of them wrong.

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.

As GLP-1 therapies reshape obesity care, Brian Hilberdink, president of U.S. Human Pharma, Boehringer Ingelheim, argues that lasting progress depends on targeting metabolic health, not just the number on the scale.

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.

Brian Hilberdink, president of U.S. Human Pharma, Boehringer Ingelheim, notes how the real obstacle in obesity care isn't how a drug is delivered, it's whether patients stay on treatment long enough to achieve lasting metabolic health.

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.

The framework’s key considerations for pharma brand managers.

Model N Senior Vice President Jesse Mendelsohn explores the hidden costs and realities of PBM-driven drug pricing and the growing challenges manufacturers face in ensuring contract compliance, formulary access and reimbursement accuracy.

Eli Lilly moves to deny 340B discounts to hospitals refusing to submit claims data under its documentation policy, escalating a months-long standoff with the American Hospital Association and prompting calls for federal intervention.

Ascidian Therapeutics has entered a global research and licensing deal with Eli Lilly to develop RNA exon-editing therapies for monogenic kidney diseases, a class of genetic conditions with an unmet need for treatment.

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.