Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Medline has updated guidance on continued use and remedies for all its branded beds and accessories, recalled over fire and entrapment risks linked to seven deaths and 35 serious injuries.
Germany's BfArM has listed an Urgent Field Safety Notice from Vascutek Ltd on its Gelweave Vascular Prosthesis; the details sit in the manufacturer's Advisory Notice.
Germany's BfArM has listed an urgent field safety notice from Löwenstein Medical for the LEONI 4, with hazard and corrective actions detailed only in the manufacturer's Advisory Notice.
The US regulator's designation covers advanced non-squamous NSCLC after anti-PD-(L)1 and platinum chemotherapy, but the company's third-quarter cash position underlines its continuing need for financing.
The cannabis company's unaudited results to 30 September 2026 show lower revenue, a smaller asset base and a continuing shareholders' deficit, despite fresh funding from convertible notes and a private placement.
The oncolytic virus developer reports $3.9M in cash, a headcount-led restructuring expected to save about $3M a year, and a first-patient dose for CLD-401 targeted for H2 2027.
The company formerly known as Quince Therapeutics says its inhaled rapamycin programme will read out first in post-lung-transplant BOS in Q1 2027, with cash expected to last through 2028.
The MRI-guided cardiac catheterisation company reports its first US sales, two children's hospital customers and extended FDA paediatric labelling in its third-quarter results.
The company formerly known as Cybin ended September 2026 with $171.1M in cash, up from March, after about $86M in net equity proceeds.
The company's PMA supplement for air and ground transport labelling remains under FDA review, with audit readiness expected in mid-December and agency inspections to follow.
The company's nine-month MD&A says IMC Holdings, including Adjupharm, went to an entity controlled by chief executive Oren Shuster on 29 September 2026.
The US biotech says non-dilutive deals, including a manufacturing sale and a ZYNYZ royalty sale, extend its funding as it focuses on investigational ADC MGC026.
The company formerly known as Plus Therapeutics posted $0.7M in diagnostic revenue for Q3 2026, added Aetna coverage and reported clean early safety data for REYOBIQ.
The Nasdaq-listed company says Corexa Pharmacy's GLP-1 dispensing drove growth, and it has regained Nasdaq compliance and launched compounded peptides under an FDA enforcement discretion policy.
The agency has accepted Intellia's BLA for lonvoguran ziclumeran with priority review and does not currently plan an advisory committee, the company said at an investor event.
The designation covers the Phase 3 DUBLIN-4 population, while BeyondSpring completes the sale of its China-linked subsidiary to Biolin and reports cash of just $0.6 million.
NeOnc will use the early January 2027 meeting to test whether Phase 2a data can back a 505(b)(2) application for NEO100 in recurrent IDH-mutant grade 4 astrocytoma.
The oncology developer says emavusertib is enrolling in CLL and PCNSL, with first CLL combination data due in December 2026, while financing extends runway just into the first quarter of 2027.
The US company expects to resubmit its dexmethylphenidate application between December 2026 and January 2027, after FDA raised manufacturing questions in a June complete response letter.
The US diagnostics firm says pivotal enrolment is finished and a backup cartridge site is secured, but its $7.38M cash runway extends only to the second quarter of 2027.
Health Canada lists a Type II recall in which Boston Scientific is correcting the instructions for use for Vercise Clinician Programmers, covering IPG recharge intervals and battery longevity estimates.
The EMA committee has recommended extending Novartis' IL-17A inhibitor secukinumab to adolescents with HS who responded inadequately to conventional systemic therapy, pending a European Commission decision.
Health Canada lists a Class II recall of Philips Azurion R3.1 systems after two software issues were found, one causing a reboot loop and one cutting motion power.
Five-year follow-up from trial VLA1553-303 shows most vaccinated adults retain neutralising antibodies above the seroresponse threshold, with older adults matching younger ones.
Valneva reports positive Phase 2 data for its tetravalent Shigella candidate, with a significant efficacy signal against S. sonnei in adults and immunogenicity in Kenyan infants.
A single lot of Secaris Nasal Gel, sold nationally in Canada, is subject to a Type II recall after the company found it may contain foreign matter.
The EMA's PRAC has released the final translations of product information text for phenobarbital, linked to a targeted signal management procedure.
EMA's veterinary signal management page sets out marketing authorisation holder duties, revised templates and the closed targeted review of phenobarbital products, which recommended product information changes for dogs.
The US biotech posted about $0.7m in royalty revenue and $5.8m in cash, and plans a Q1 2027 close for its Santersus acquisition.
The company reported third-quarter 2026 revenue of $5.4 million, with AlterG up 18% while ReWalk exoskeleton sales declined during its shift away from direct sales.
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.