Layoffs tied to AI adoption will not be uniform; they will vary by sector, job function, and regulatory exposure. Nowhere is this more complex than in healthcare, where legal constraints, patient safety obligations, and labor dynamics intersect with rapid technological change.

The post AI-Driven Layoffs In Healthcare: Navigating Legal Risks and Operational Challenges appeared first on MedCity News.

Merck’s HIV drug Idvynso could become a drug choice for patients who need to switch from Gilead Sciences’ Biktarvy for safety or tolerability reasons. The Merck combination drug pairs two molecules that bring different mechanisms of action to suppressing HIV.

The post FDA Nod for Merck HIV Drug Brings Competition to a Gilead Sciences Antiretroviral appeared first on MedCity News.

The Department of Justice has sued both OhioHealth and NewYork-Presbyterian Hospital this year, alleging that they use contracting tactics that limit competition and keep healthcare prices high. The cases mark a broader push by regulators to scrutinize how health systems use “all-or-nothing” contracts to shape insurance networks and patient access.

The post Inside The DOJ’s Hospital Contracting Crackdown: What Message Are the Feds Sending? appeared first on MedCity News.

Jefferson Health in Philadelphia is suing Aetna over a new Medicare Advantage payment policy that hospitals say unfairly reduces reimbursements for legitimate inpatient stays. The case highlights a broader clash between providers and Medicare Advantage plans over “downcoding” short hospital stays and controlling costs.

The post Jefferson Health Sues Aetna As Providers’ Frustration with MA Grows appeared first on MedCity News.

Soleno Therapeutics brings Neurocrine Biosciences Vykat XR, a drug commercialized for treating the rare genetic disease Prader-Willi syndrome. This blockbuster prospect complements Crenessity, a Neurocrine drug approved for treating a rare endocrine disorder called congenital adrenal hyperplasia.

The post Neurocrine’s $2.9B Soleno Buyout Brings What Could Become Its Next Blockbuster Drug appeared first on MedCity News.

Generic medicines face no tariffs, though the Trump administration reserves the right to revisit that in the future. Some branded drugmakers face a reduced tariff rate, but that could change if they don’t reach a so-called most-favored nation drug price deal.

The post The Drug Companies Avoiding Trump’s Tariffs — For Now appeared first on MedCity News.

A group of 131 hospitals has sued HHS over a CMS policy they say improperly reduces Medicare disproportionate share hospital (DSH) payments. The lawsuit is the latest in a decade-long legal battle over how the agency counts patient days and calculates payments for safety net hospitals.

The post Why 131 Hospitals Are Suing HHS Over Alleged Underpayment appeared first on MedCity News.

Biogen’s Apellis Pharmaceuticals acquisition comes nearly two years after the drugmaker purchased immunology startup Human Immunology Biosciences. CEO Chris Viehbacher said Apellis accelerates Biogen’s expansion in nephrology, supporting a HI-Bio drug currently in pivotal testing for three kidney conditions.

The post Why Biogen Is Paying $5.6B to Buy Apellis Pharma appeared first on MedCity News.

FDA approval for Eli Lilly’s oral GLP-1 drug, Foundayo, comes about three months after Novo Nordisk launched its Wegovy pill. While clinical trial results for both daily pills showed comparable weight reduction, Lilly’s pill offers patients a slight dosing advantage.

The post Eli Lilly Gets Speedy FDA Nod for Oral GLP-1 Drug, a Competitor to New Novo Nordisk Pill appeared first on MedCity News.

Centessa Pharmaceuticals’ cleminorexton is part of the orexin agonist drug class, which could introduce a new approach to the treatment of narcolepsy and other sleep disorders. Acquiring Centessa brings Eli Lilly into a group of clinical-stage orexin agonist drug developers that includes Takeda Pharmaceutical, Alkermes, and Eisai.

The post Eli Lilly’s Neuro Prospects Expand to Sleep Science With $6.3B Centessa Acquisition appeared first on MedCity News.

The Department of Justice filed an antitrust lawsuit against NewYork-Presbyterian, alleging the hospital used “all-or-nothing” contracts that blocked lower-cost plans and limited competition. The case comes just five weeks after the Justice Department filed a similar lawsuit against OhioHealth.

The post DOJ Cracks Down on Unfair Contracts with New Lawsuit Against NewYork-Presbyterian appeared first on MedCity News.

Denali Therapeutics’ Avlayah received FDA approval for treating Hunter syndrome, a rare neurological disorder. The biologic medicine uses Denali’s proprietary drug delivery technology to cross the protective blood-brain barrier.

The post FDA Approval for Denali Therapeutics Blazes a New Trail for Brain-Penetrating Drugs appeared first on MedCity News.

Merck has been acquiring assets that could help make up for the coming revenue decline as its top product, the cancer drug Keytruda, drops off the patent cliff. Terns Pharmaceuticals’ lead product candidate, in development for treating a type of leukemia, could offer dosing and efficacy advantages over the Novartis drug Scemblix.

The post Merck’s $6.7B Terns Acquisition Positions It to Challenge a Blockbuster Novartis Cancer Drug appeared first on MedCity News.

Gilead Sciences is acquiring Ouro Medicines, a startup developing T cell engagers for a range of autoimmune diseases. Separately, Gilead is negotiating a deal with Galapagos to share in the development and potential commercialization of the Ouro drug.

The post Gilead Sciences Gains an Opportunity for Immune System Reset With $1.7B Ouro Acquisition appeared first on MedCity News.

FDA approval of Icotyde covers the treatment of adults and adolescents with moderate-to-severe plaque psoriasis. This once-daily pill, developed by partners Johnson & Johnson and Protagonist Therapeutics, offers an easier dosing option compared to injectables and is projected to become a blockbuster seller across several immunological indications.

The post J&J Gets FDA Nod for Plaque Psoriasis Pill Positioned to Compete With Injectables appeared first on MedCity News.

Aldeyra said the FDA did not ask for another clinical trial for reproxalap in dry eye disease, but there is a “lack of substantial evidence” that warrants exploration about the reasons for trial failures to identify the appropriate patients for the eye drop. AbbVie holds an option to collaborate on reproxalab’s commercialization.

The post Lacking Evidence, FDA Rejects Aldeyra Dry Eye Disease Drug appeared first on MedCity News.

GuardDog Telehealth admitted it misrepresented its services to access patients’ health information, marking the first major concession in Epic’s lawsuit against Health Gorilla and other defendants accused of exploiting interoperability networks. The broader case is still ongoing.

The post Why The Epic-Health Gorilla Case Just Got Juicier appeared first on MedCity News.

Leucovorin is now approved for cerebral folate deficiency months after FDA Commissioner Marty Makary claimed the decades-old generic drug had promise for treating autism. The FDA’s review was based on published literature and real-world evidence.

The post FDA Drug Approval Marks a First for a Disease — But It’s Not Autism appeared first on MedCity News.

For patients, recalls can fail to protect them — not because they came too late, but because they stop at notification and never fully translate into action.

The post When Recalls Fail — The Gap Between Notification and Action appeared first on MedCity News.

The FDA said consolidating safety reporting into a single platform, the Adverse Event Monitoring System (AEMS), will increase transparency and reduce costs. But like the legacy systems it replaces, AEMS reports are unverified so causation and frequency of events cannot be determined.

The post FDA Transparency Push Expands to Monitoring Safety of Vaccines and Other Regulated Products appeared first on MedCity News.

The settlement demonstrates that enforcement risk is real and substantial, but it also highlights an opportunity. Medicare Advantage oversight does not require years of new rulemaking or experimental pilots because the technical capability to validate documentation at scale already exists and can be deployed today.

The post The Kaiser Settlement Should End the Guesswork in Medicare Advantage Oversight appeared first on MedCity News.

Under the settlement, Genevant Sciences and Arbutus Biopharma will grant Moderna a non-exclusive license to their lipid nanoparticle technology for mRNA delivery in infectious disease vaccines. If Moderna’s full financial payout to the companies is reached, it would rank among the largest disclosed patent settlements in biopharmaceutical industry history.

The post Moderna to Pay Up to $2.25B to Settle Patent Suit Over Covid-19 Vaccine Technology appeared first on MedCity News.

The label expansion for Boehringer Ingelheim’s Hernexeos was made under an FDA pilot program that accelerates regulatory review of products with national interest. The daily pill is now approved as a first-line treatment for HER2-positive non-small lung cancer, an indication with few treatment options.

The post FDA Voucher Leads to Speedy Approval of Boehringer Drug for First-Line Use in Lung Cancer appeared first on MedCity News.

The core challenge for leadership is no longer merely managing direct vendors; it’s the cascading risk of the “nth-party” supplier.

The post Compliance: Why Your Vendor’s Vendor is a Growth Risk appeared first on MedCity News.

The Department of Justice and the state of Ohio filed an antitrust lawsuit against OhioHealth this week, alleging the health system used “all-or-nothing” contracts that force insurers to include all of its hospitals and physicians. The case highlights federal and state scrutiny of hospital consolidation and restrictive contracting practices — with potential implications for payers, patients and healthcare markets across the country.

The post DOJ, Ohio File Antitrust Suit Against OhioHealth Over Payer Contracts appeared first on MedCity News.

Shalin Shah, CEO of Marius Pharmaceuticals, which makes an oral testosterone replacement drug, thinks TRT therapy should no longer be regulated as a controlled substance

The post MedCity Pivot Podcast: Should Testosterone Replacement Therapy Be Less Regulated? appeared first on MedCity News.

The FDA asked for more data to determine whether Disc Medicine’s bitopertin is benefiting patients with erythropoietic protoporphyria, a rare blood disorder. Analysts say it’s a surprising delay considering bitopertin is one of the first drugs in a new FDA pilot program that speeds up regulatory review of medicines deemed critical for national security or public health.

The post Disc Medicine Rare Disease Drug Picked for Faster Regulatory Review Is Rejected by the FDA appeared first on MedCity News.

PTC Therapeutics said it cannot resolve differences it has with the FDA in interpreting clinical trial data for Translarna, a drug it developed for Duchenne muscular dystrophy. The rare disease drug developer’s decision to withdraw Translarna’s FDA submission comes nearly a year after a negative European regulatory decision for the drug.

The post PTC Therapeutics Ends Bid to Seek FDA Approval for Rare Muscle Disease Drug appeared first on MedCity News.

The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company said the agency’s justification for refusing a review is inconsistent with guidance given prior to the start of Phase 3 testing.

The post Moderna Says FDA Refusal to Review mRNA Flu Vaccine Contradicts Federal Rules, Prior Guidance appeared first on MedCity News.

The Consolidated Appropriations Act of 2026 and the Department of Labor’s proposed rule implement major PBM reforms for employers, but don’t include everything they want, including a ban on spread pricing.

The post Employers Celebrated PBM Reform. The Reality Is More Complicated appeared first on MedCity News.