Know What's Happening in Healthcare
Know What's Happening in Healthcare
FDA approves KRESLADI, first CIRM‑backed gene‑editing therapy
The FDA cleared KRESLADI, a gene‑editing treatment from Rocket Pharmaceuticals for severe leukocyte adhesion deficiency‑I in children, eliminating the need for a bone‑marrow donor. It is the first product directly funded by California’s Institute for Regenerative Medicine to receive approval.
Also developing:
By the numbers: Syneron Bio raises $150M Series B
Between January and February 2026 the FDA issued a cascade of regulatory updates covering new drug approvals, safety‑label revisions, draft guidances, and consumer alerts. The agency granted approval for pembrolizumab combined with paclitaxel to treat platinum‑resistant ovarian, fallopian tube, or peritoneal carcinoma and added DPD‑deficiency warnings to capecitabine and 5‑FU labels. At the same time, multiple public notifications warned that several marketed sexual‑enhancement chocolates contain undeclared drug ingredients. Additionally, the Orange Book data files were refreshed and new draft guidances on medical gases, patient‑preference studies, and Bayesian trial methods were released.
CMS announced a comprehensive overhaul of its reimbursement rules for skin substitutes, high‑cost dressings used in chronic wound care. The policy tightens medical‑necessity criteria, promotes evidence‑based alternatives, and leverages negotiated pricing. The Congressional Budget Office incorporated these changes into its...
Healthcare interoperability is accelerating data exchange among hospitals, labs, insurers and pharmacies, but each connection expands the sector's attack surface. Misconfigured integrations, outdated protocols and weak identity controls can leak sensitive patient records, turning routine sharing into a security liability....
GLP‑1 therapies are entering a new regulatory phase as the FDA stripped suicide‑ideation warnings from Saxenda, Wegovy and Zepbound and signaled tighter controls on compounded pills. At the same time, Novo Nordisk’s oral Wegovy has become the fastest drug launch...
Pharmacy leaders are navigating tighter regulations and shifting reimbursement models while uncovering growth avenues in specialty and home‑infusion services. Executives emphasize the need for pharmacists to act as connectors between clinicians, payers, and manufacturers, blending clinical insight with business acumen....
The FDA has issued a warning that Boner Bears Chocolate, sold as a sexual‑enhancement supplement, contains undeclared sildenafil, the active ingredient in prescription Viagra. Laboratory testing confirmed the hidden drug, which is not listed on the product label. The agency...
Renown Health announced the promotion of longtime executive Jenny Juchtzer to vice president of payer contracting. Juchtzer, who has spent nearly two decades at the organization and most recently led payer contracting, will now oversee all hospital and professional managed‑care...
Dexcom is lobbying the Centers for Medicare & Medicaid Services for expanded coverage of its continuous glucose monitors (CGMs) for Type 2 diabetes patients who do not use insulin. The company estimates the change could make CGMs available to roughly 12 million...
The National Commission on Certification of Physician Assistants released its 2024 compensation report, showing a mean PA salary of $129,291 nationwide. California tops the list with a mean income of $151,351, while Nevada, Connecticut, Alaska, and Washington round out the...
Humana is negotiating a roughly $1 billion purchase of Florida‑based MaxHealth, a primary‑care network focused on adults and seniors. MaxHealth is owned by Arsenal Capital Partners’ Best Value Healthcare, and the deal would deepen Humana’s primary‑care footprint after recent growth in...
Hospitals are redefining supply chain leadership to encompass enterprise strategy, digital transformation, and resilience. This shift is prompting health systems nationwide to recruit senior supply chain executives with broader, analytics‑driven responsibilities. In the past week, ten systems—including Baptist Memorial, Boston...
Vertex Pharmaceuticals and CRISPR Therapeutics forecast combined Casgevy gene‑therapy and Journavx pain‑drug sales of $500 million in 2026, a 185 % jump from 2025. The therapy generated $115.8 million in 2025, with Q4 revenue of $54.8 million, and treated 111 patients that year, up...
Moonwalk Biosciences, founded by CRISPR pioneer Feng Zhang and former Illumina CTO Alex Aravanis, announced a strategic pivot from epigenetic editing to siRNA‑based obesity therapies. The company secured a $120 million Series A round to fund the new platform, which targets liver‑expressed...
Siemens Healthineers and Mayo Clinic have expanded their strategic partnership to accelerate AI‑driven imaging and interventional technologies for neurodegenerative disease, prostate cancer, and metastatic liver tumors. The agreement emphasizes AI‑enabled ultra‑high‑field MRI protocols for Alzheimer’s detection, AI tools to reduce...
University of Hertfordshire researchers, in partnership with regional NHS bodies, have built an AI forecasting model that uses five years of historical data to predict healthcare demand. The system integrates admissions, bed capacity, workforce availability, and demographic factors to generate...
A Korean nationwide cohort of 3.86 million adults found that diabetes raises the risk of pancreatic cystic neoplasms (PCNs), with longer disease duration conferring greater risk. Incidence rose from 0.72 per 1,000 person‑years in normoglycemic individuals to 1.82 in those with...
Coronary computed tomography angiography (CCTA) is becoming a core tool for interventional cardiologists, enabling comprehensive pre‑procedure planning and reducing reliance on costly intravascular imaging. The addition of fractional flow reserve derived from CT (FFR‑CT) merges anatomical and physiological assessment, streamlining...
Moderna’s chief financial officer indicated that the company cannot yet confirm whether its 2028 cash‑flow break‑even goal will hold, as the outlook for its seasonal flu vaccine remains uncertain. The flu shot, once expected to be a steady revenue stream,...
The FDA’s 2026 novel drug approvals catalogue highlights all new molecular entities receiving first‑time U.S. marketing authorization. A novel drug is defined as a product never previously approved or sold in the United States, and each entry links to the...
The AAPS National Biotechnology Conference will take place May 11‑14, 2026 in San Diego, gathering leading pharmaceutical scientists to discuss the latest advances in biologics, biotechnology products, and advanced therapies. The four‑day event offers sessions on new modalities, technologies, and novel strategies...
The episode examines the University of Minnesota Medical School’s decision to discontinue a UnitedHealth Group‑sponsored course after investigative reporting by Dr. Allison Leopold exposed the curriculum as corporate propaganda rather than unbiased medical education. Leopold, a participant in the pilot,...
Chronic kidney disease (CKD) impacts more than one in seven U.S. adults and kills more people annually than breast or prostate cancer, yet it remains under‑diagnosed, especially among women and minority groups. Value‑based care (VBC) models shift focus to early...
Oregon lawmakers are reviewing Senate Bill 1575, which would bar hospices with fraud histories or substandard care in other states from obtaining licenses in Oregon. The bill mandates the Oregon Health Authority to review applicants' Consumer Assessment of Healthcare Providers...
Eli Lilly has amassed roughly $1.5 billion worth of its experimental obesity drug orforglipron. The company began stockpiling the product months before the U.S. Food and Drug Administration is expected to grant approval later this year. Orforglipron, a GLP‑1 receptor agonist, joins...
The FDA unexpectedly refused to review Moderna’s mRNA‑based flu vaccine, sparking alarm across biotech firms. Pediatricians are confronting the Department of Health and Human Services (HHS), demanding transparent guidance on pediatric flu immunization. The decision highlights perceived regulatory volatility under...
The FDA has published a series of downloadable spreadsheets detailing self‑identified generic drug facilities, sites and organizations for fiscal years 2014 through 2026. Each annual file lists manufacturers, contract manufacturers, and other entities that the agency has flagged as part...
Intermountain Health’s chief information security officer Erik Decker unveiled the SMART toolkit, a framework that maps an organization’s critical clinical and administrative functions to assess cyber‑risk exposure. The tool helps leaders identify which services must remain operational during a breach...
The medical device sector is grappling with a wave of new and proposed tariffs that have lifted costs for metals, electronics, and finished components throughout global supply chains. Manufacturers must decide whether to absorb these higher expenses, pass them to...
Aveanna Healthcare Holdings CEO Jeff Shaner warned that hospice acquisition multiples remain excessively high, often exceeding 10x and sometimes reaching 15x‑17x. The company, which is evaluating growth options, says it will not pursue hospice deals unless valuations fall into the...
Immunic announced an oversubscribed private placement raising up to $400 million to fund its shift toward a commercial‑stage biotech. The capital injection will support late‑stage development programs and accelerate the search for a new chief executive officer. Meanwhile, Vertex Pharmaceuticals disclosed...
The FDA’s consumer‑updates page aggregates more than 60 articles that explain how the agency regulates prescription and over‑the‑counter drugs and communicates risks and benefits to the public. Topics range from hormone‑replacement therapy and antibiotic stewardship to product recalls, safe disposal,...
A new psoriasis severity tool, G2‑PASE, combines Physician Global Assessment and body surface area with a nonlinear weighting to approximate the Psoriasis Area and Severity Index. In a Canadian registry of 1,803 patients, it demonstrated a Pearson correlation of 0.83...
The episode breaks down CMS’s new ACCESS Model, which replaces fee‑for‑service chronic care payments with a per‑beneficiary Outcome‑Aligned Payment (OAP) that is partly withheld until specific clinical and patient‑reported outcomes are met. It explains the four clinical tracks—early and advanced...
The CDC announced a multistate outbreak of extensively drug‑resistant Salmonella linked to Rosabella brand moringa powder capsules, with seven confirmed illnesses across seven states and three hospitalizations. The strain’s resistance means standard antibiotics may be ineffective, requiring alternative treatments. Listeners...
Virtual care has shifted from a convenience to a core delivery model, prompting physicians to rethink how they build trust through a screen. Small adjustments in communication style, workflow, and technology can deepen patient connections and mitigate the risk of...
Healthcare systems are rapidly deploying AI for diagnosis, documentation, scheduling and patient communication, but many clinicians and support staff lack the training to use these tools effectively. The article argues that one‑time, checkbox‑style training creates risks such as automation bias...
The episode opens with a celebration of Women in Science Day, highlighting the historic origin of the term “scientist” and the push for greater female leadership in biotech. Medra CEO Michelle Lee discusses how the company is merging robotics with...
$CMPS first-in-line for potential psychedelic approval for Treatment Resistant Depression (TRD) . Likely war between "Old School FDA" and MAHA movement. Will be exciting to see the outcome. $HELP with strong data for Major Depressive Disorder (MDD) and Breakthrough Therapy Designation. New...
Working on a story about where AI is actually creating more, rather than less, work for clinicians. (As in, adding additional grunt work or even creating entirely new and tiresome workflows.) Reach out if you'd like to contribute.
Ovid Therapeutics, under new CEO Meg Alexander, is re‑orienting its neuroscience pipeline toward first‑in‑class KCC2 modulators while advancing a drug‑resistant epilepsy candidate toward Phase 2. The company’s earlier flagship, soticlestat, failed in Phase 3, eliminating $600 million in potential milestones, prompting a strategic...
To invest the billions it costs to make new medicines, companies need to be able to trust the word and actions of the FDA. To capaciously change the rules at the end of the game ultimately hurts patients.
A successful hunt of human genome variants identifying some (with MR) that provide causal evidence that BMI affects microbe composition @NatureGenet https://t.co/1uxvnFNrbK https://t.co/SuItRHAnFe
Vertex Pharmaceuticals reported that its late‑stage RAINIER trial of povetacicept in IgA nephropathy is proceeding without safety concerns, with primary data expected in the first half of 2026. The company is leveraging a priority‑review voucher for the upcoming FDA filing...
The American Academy of Pediatrics has become a leader in the effort to reverse RFK Jr.'s vaccine policies. The success — or failure — of the group's approach will have consequences for kids' health nationwide. Inside the AAP's plan for the MAHA...
Organotics, a new biotech startup, is leveraging patient‑derived brain organoids to accelerate early‑stage testing of neuropsychiatric drugs. By reprogramming a patient’s blood or skin cells into induced pluripotent stem cells, the company creates vascularized, multi‑region mini‑brains that reflect individual genetics....
India‑based health‑AI startup Krigat captured the Supernova AI MEA Champion title in Cairo, outpacing 74 finalists from over 30 countries. The win includes a $10,000 equity‑free cash prize and heightened visibility at the AI Everything MEA summit. Krigat’s platform leverages...
Jason Wilt, an emergency and sports‑medicine physician, recounts his stint at Williams‑Sonoma and how the harsh retail environment taught him to handle difficult patients. He draws parallels between customer aggression and patient hostility, noting that many patients’ frustration stems from...
Paul Hudson has struggled to revitalize Sanofi’s R&D engine despite a series of high‑profile acquisitions since becoming CEO in 2019. The French group’s pipeline has underperformed, and recent buyouts have failed to deliver the expected boost in innovative drug candidates....
