Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Belite Bio says the FDA will not convene an advisory committee for its Stargardt disease type 1 application, as filings also proceed in Japan and through the Access Consortium.
The US biotech says PERFORMA is progressing, with 52-week topline data due in 2029, and an FDA End-of-Phase 2 meeting on alcohol use disorder is set for December.
Pharvaris reported Q3 2026 results, with the FDA reviewing its NDA for on-demand deucrictibant IR and the EMA assessing the matching marketing authorisation application.
The competition authority found problems only in UK vehicle refinish coatings supply, and the companies plan to offer the divestment already agreed with the European Commission.
The US CBD maker reports its smallest operating loss since 2019 and warns that a federal hemp restriction taking effect on 11 December could cover its full-spectrum products.
EyePoint will wind down wet AMD development of DURAVYU after LUGANO and LUCIA missed their primary endpoint, redirecting resources to its diabetic macular edema trials.
The company reported updated LEGEND Cohort 1 data in BCG-unresponsive high-risk NMIBC with CIS and said it agreed the efficacy-evaluable population with the FDA.
Lilly gains exclusive rights to develop estetrol combinations in women's health and cardiometabolic disease, plus a US co-commercialisation option on Richter's FYLREVY, and will buy about $15M of Richter shares.
Santhera has granted SteinCares exclusive rights to distribute vamorolone across 31 Latin American and Caribbean countries, with Brazil first in line and ANVISA registration to be pursued.
The Dutch inspectorate has published a manufacturer warning saying unintended touch signals at the LEONI 4 screen edge can temporarily limit or fully block touchscreen operation.
Beaver-Visitec International says certain units may have an open seal that cannot guarantee sterility, according to a field safety notice published by the Dutch inspectorate IGJ.
A technical investigation prompted by a customer complaint found certain lots of Remel's R30166901 reagent fail to react with the ATCC13102 control strain within the 60 seconds set in the instructions for use.
IGJ has posted a manufacturer warning on the Vercise Neural Navigator 5 software, centred on how an inaccurate battery estimate could lead to interrupted stimulation.
The US agency is prolonging, with modifications, its moratoria on new hospice and home health agency enrolment by six months, citing fraud, waste and abuse.
The German regulator has published a PTW Freiburg field safety notice on Track-it, a radiotherapy treatment planning product, but the specifics sit in the manufacturer's attached advisory.
Germany's BfArM has listed an urgent field safety notice from Richter Rubber Technology Sdn Bhd on condoms, but the public entry gives no details of the problem.
The German regulator has listed an urgent field safety notice from DH Healthcare GmbH for ORBIS Medication, but the public listing gives no details of the problem or required actions.
A decision of 12 November 2026 extends the list under Article L. 5126-6, 1° of the Public Health Code with an anticancer, an antiviral and a multiple sclerosis capsule.
Portugal's medicines and health products authority says registration of devices placed on the market before 28 May 2026 must be finished by 28 November, with a notified body deadline following in 2027.
Austria's BASG summarises the CHMP's 12-15 October meeting, which recommended new products for obesity, type 2 diabetes, pancreatic cancer, glioma and achondroplasia, plus several extensions of indication.
Austria's BASG has published its summary of the CHMP's September 2026 meeting, listing seven therapeutic areas with positive opinions and four new medicines described in detail.
The IGJ has released a supervisory report on Maddox Pharma Swiss BV, but the available description does not state any findings or the severity of any deficiencies.
The IGJ has released an inspection report on Campro Scientific GmbH's Veenendaal site, but the material available does not set out the findings or any required improvements.
Ravimiamet says devices placed on the market before 28 May 2026 and still being supplied must be registered in EUDAMED by 28 November 2026.
DKMA says production problems at STADA Nordic ApS are disrupting supply of Aprepitant 'Stada' 125+80 mg hard capsules, with disruption forecast from late October 2026 to early March 2027.
The Danish Medicines Agency reports production problems at STADA Nordic ApS, with supply of the 80 mg hard capsules expected to be affected from early November 2026 to early March 2027.
France's medicines agency has refreshed its regional list of hospital and community pharmacies with at least one trained pharmacist authorised to order and dispense medical cannabis under the experimentation.
The UK regulator has posted its second-quarter performance report and an accompanying letter, extending a quarterly transparency series first published in August.
Portugal's regulator has issued Deliberation 110/CD/2026, extending temporary export suspensions to protect supply of critical medicines, exceptional-use products, and all quetiapine oral solids and estradiol medicines.
Methodological guideline MP 155/2026 sets requirements and procedure for pharmacy permit holders in Slovakia that plan to offer vaccination as part of pharmacy care.
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.