FDA

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.

In today's Pharmaceutical Executive Daily, Invivyd's chief scientific officer discusses a platform designed to predict future viral variants ahead of time, Bristol Myers Squibb expands its AI compute infrastructure with Nvidia to build what it calls the most powerful AI factory in life sciences, and FDA clears Consano Bio's IND for a non-opioid biologic targeting chronic sciatica.

FDA has cleared Consano Bio's IND for C-1101, a platelet-derived biologic delivered via single epidural injection, enabling U.S. expansion of a Phase I trial targeting chronic sciatica.

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.

In today's Pharmaceutical Executive Daily, Steer Bio discusses its regenerative cell therapy platform for cancer-related lymphedema, FDA approves Celcuity's Revtorpyk as the first pan-PI3K and mTORC1/2 inhibitor for advanced breast cancer, and Insilico Medicine enters a strategic alliance with Bora Pharmaceuticals worth up to $2.5 billion.

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.

In today's Pharmaceutical Executive Daily, AstraZeneca acquires global rights to Dizal Pharmaceutical's lung cancer drug Zegfrovy in a deal worth up to $1.5 billion, FDA approves a subcutaneous formulation of Leqembi for early Alzheimer's disease, and a pharmacy executive weighs in on the education gap facing patients starting GLP-1 therapies.

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 issued a complete response letter to Elevar Therapeutics for its rivoceranib and camrelizumab combination in first-line hepatocellular carcinoma, rejecting the application over manufacturing deficiencies rather than clinical concerns.

FDA has paused public release of complete response letters while reviewing a citizen petition challenging the legal basis of the practice, stalling a transparency initiative the agency launched less than a year ago.

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.

In today's Pharmaceutical Executive Daily, FDA approves Ennumo, a pharma roundup covers Chemomab Therapeutics' merger with AI-enabled precision medicine company Scipher Medicine and Teva's global licensing agreement with Polpharma Biologics, and Alina Chesnokova of Cencora examines how the rise of cold chain-dependent specialty therapies is fundamentally changing how pharmaceutical manufacturers think about commercialization strategy and supply chain partnerships.

FDA has approved Accord BioPharma's Ennumo as a second pegfilgrastim biosimilar, giving the company what it claims is the world's largest G-CSF biosimilar portfolio from a single manufacture.

FDA selected seven companies to participate in its new PreCheck Pilot Program, offering earlier regulatory engagement and expedited facility review to incentivize domestic drug manufacturing.

In today's Pharmaceutical Executive Daily, the FDA approves Gilead's Trodelvy for the first-line treatment of metastatic triple-negative breast cancer — as both a monotherapy and in combination with Keytruda — marking the first new backbone therapy option for this aggressive disease in more than two decades, Novartis announces a $105 million collaborative agreement with Antares Therapeutics to jointly discover and develop first-in-class precision medicines in oncology and other serious diseases, with potential milestones totaling $1.8 billion, and Pharmaceutical Executive speaks with Kyle Smith, president and COO of Aprecia Pharmaceuticals, on the real-world benefits and persistent challenges of operating as a fully domestic manufacturer in an era of tariffs and supply chain pressure.

The FDA has approved Trodelvy (sacituzumab govitecan-hziy) for first-line treatment of metastatic triple-negative breast cancer as both a monotherapy and in combination with pembrolizumab, supported by Phase 3 data from the ASCENT-03 and ASCENT-04 trials.

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.