Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The clinical-stage company says it will need substantial extra funding, while a Phase 1 trial supports a single fixed dose per visit of inhaled mebufotenin.
The company says final Phase 1 device data support one fixed dose per visit, with an End-of-Phase 2 meeting for treatment-resistant depression expected in Q1 2027.
PAVmed's preliminary Q3 update says Lucid has been paid by Medicare since October, while Veris Health has frozen its monitor design and started an animal study ahead of an early-2027 submission.
Aardvark Therapeutics says the FDA cleared its ARD-101 IND after cardiac safety studies, allowing a 200 mg twice-daily open-label trial, with a development-plan meeting due in Q1 2027.
The US biotech reports early DA-1726 liver-fat and weight data from a very small cohort, and sets out FDA, Phase 2a and Phase 2 steps, with $8.8M in cash.
The company reports a $7.9M net loss for the quarter, clears its Oaktree balance and adds a Phase 2 IBS-D asset licensed from Cedars-Sinai.
Interim Phase 1b/2a data in oculopharyngeal muscular dystrophy dysphagia showed responses in every Cohort 1 and 2 patient, with no serious adverse events, alongside Benitec's fiscal first-quarter results.
The US regulator has allowed a Phase 1b study of TBS-2025 in relapsed or refractory mutant NPM1 acute myeloid leukaemia, as TuHURA reports third-quarter results with $1.9 million in cash.
The US company says payer coverage for its PSVT nasal spray has reached about two-thirds of covered lives, and its cash runway now extends into late 2028.
The US dermatology company also reports a customs ruling on its redesigned RhodoLED XL-C lamp and a new sNDA to widen the actinic keratosis label.
The European Medicines Agency has released a draft guideline on veterinary good pharmacovigilance practices (VGVP) covering a list of medically important VeDDRA terms.
The draft guideline would replace the current appendix to the VGVP signal management module, with comments open until 31 January 2027 alongside a separate consultation on the module's revision.
The EMA committee has recommended obinutuzumab for adults with moderate-to-severe, active SLE despite standard therapy, based on phase III ALLEGORY data; a European Commission decision is expected soon.
The EMA committee has backed obinutuzumab for adults with moderate-to-severe, active systemic lupus erythematosus despite standard therapy, with a European Commission decision expected shortly.
The company signed a start-up agreement with Thermo Fisher Scientific's clinical research business for a Phase 2 progressive MS trial, after FDA cleared its IND in August.
The cannabis operator's Q3 2026 loss stems from a $5.0M charge on acquiring Rogue EBC, while it holds guidance and awaits approvals for a New York deal.
Bavarian Nordic held its upgraded 2026 guidance of about DKK 6.1bn in revenue and a roughly 32% EBITDA margin, with travel vaccines offsetting a flat quarter overall.
Germany's medicines and devices regulator has published a manufacturer notice on the IntelliVue Patient Monitor, but the public listing does not describe the problem or the corrective action.
Germany's regulator has published a manufacturer advisory on various EPflex Feinwerktechnik guidewires, but the listing itself gives no detail on the problem or the devices affected.
Germany's BfArM has posted an Urgent Field Safety Notice from QuidelOrtho covering VITROS Chemistry Products A1c Slides, but the listing itself gives no details of the issue.
The US antitrust agency says combining the two largest distributors to veterinary clinics would raise prices and erode service quality across animal health supply.
The Danish Medicines Agency says quality problems are disrupting supply of Laboratoires Thea's diclofenac eye drops, with foreign packs allowed under section 29(2) of the Medicines Act.
Chad Monroe admitted conspiring to bill Medicare for unwanted braces and genetic tests, with kickbacks from laboratories and telemedicine firms, and to obtaining a PPP loan fraudulently.
Kwame Raoul's office has announced charges over alleged Medicaid fraud, naming two Palos Heights women; the source gives no link to medicines or pharmaceutical firms.
Delly Shabani admitted conspiracy to commit health care fraud over mental health services billed to D.C. Medicaid that were never provided or were grossly inflated; sentencing is pending.
Two companies behind a Clarksville pain management clinic and two managers will pay $1.5m to settle False Claims Act allegations involving Medicare and VA billing for diagnostic testing.
A 31-count federal indictment in Florida charges a Jacksonville man with health care fraud and money laundering, and an accountant with money laundering.
DKMA says Lipomed GmbH's dacarbazine 500 mg infusion powder has been in short supply since April 2026, with disruption expected through December 2027 for commercial reasons.
Essential Pharma Limited has permanently stopped marketing Methergin solution for injection in Denmark from early November 2026, citing production problems, according to the Danish Medicines Agency.
The Nashville oncology practice self-disclosed the conduct to HHS OIG and settled allegations under the Civil Monetary Penalties Law, with damages based on the nurse's full pay and benefits.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.