Approvals, CHMP opinions, FDA decisions, guidelines, designations and regulatory policy.
CBER's product page for Grifols' nucleic acid test lists a June 2026 approval letter alongside earlier approvals, with the indication covering blood, plasma, organ and tissue donors.
Italy's medicines agency is checking whether registries active for several years still serve their original purpose, with closures to be announced on its website.
The automated immunohistochemistry test is FDA-registered as Class I and carries IVDR Class C approval in the EU, and joins Roche's recent MTAP and Claudin-4 assays.
DBV Technologies says it submitted its Biologics License Application on 29 September, with an FDA filing and priority-review decision expected in the fourth quarter of 2026.
Health Canada reports a syngo.via MR Flow Quantification issue that truncates the final cardiac phase and systematically underestimates flow parameters in retrospectively gated 2D data.
The company reported Q3 net sales of $5.138bn and lowered its fourth-quarter guidance to a 1% to 3% decline, while announcing FDA clearances and new CPT codes.
All nine patients in the first-in-human Phase 1b/2a study are formal responders, and the high-dose cohort showed larger three-month gains in swallowing measures.
Labcorp says the US regulator has approved its PGDx elio tissue complete test as a companion diagnostic to help identify patients with advanced melanoma.
The US regulator has accepted Palvella's NDA for QTORIN 3.9% rapamycin anhydrous gel and set a PDUFA date of 28 February 2027.
The US Centers for Medicare & Medicaid Services has issued CMS-1846-F, the final rule setting Medicare payment policy for dialysis care in calendar year 2027.
CMS reports that major employers support bringing electronic prior authorization to self-funded, employer-sponsored health plans, adding momentum to efforts to cut administrative burden.
An amendment to Act No. 362/2011 Coll. limits the validity of supply-interruption notifications to 60 days and requires MAHs to restate reasons and expected restocking dates when re-notifying.
The Paul-Ehrlich-Institut and BfArM say a technical error blocked online suspected adverse reaction reports from 7 to 9 October 2026, and ask affected reporters to submit again.
The Paul-Ehrlich-Institut has permitted foreign-language packs of Bavarian Nordic's chikungunya vaccine from 19 October to 15 November 2026, after the company reported a supply shortage.
A decision dated 27 October 2026 amends the 'médication officinale' list, adding an arnica gel and two homeopathic granule products to Annex III.
The French medicines agency published the decision on 28 October; the notice does not say which generic groups or products are affected.
A Commission decision adopted on 26 October 2026 adds Singapore to the list of recognised third countries for importing active substances, once the implementing decision enters into force.
DG SANTE has released a Health Security Committee opinion on mosquito-borne diseases, though the available information does not set out its content, scope or any obligations.
Implementing Regulation (EU) 2026/2300 authorises the 'Active chlorine based products BPF' family held by CID LINES NV under the Biocidal Products Regulation.
The agency's draft guidance sets out how an individualized genome editing product with several variants can be covered by one Biologics License Application, including after licensure.
Roche says its benchtop cobas smart e immunoassay platform, planned to offer over 100 assays, can bring central-lab-comparable results to smaller laboratories and clinics.
The insulin pump maker plans to resubmit its dosing algorithm in mid-Q4 2026 with added simulator data, while winning FDA clearance for Mint.
Wave Life Sciences says the FDA has aligned with a one-year interim analysis on AATD biomarkers that could support accelerated approval of its RNA editing therapy WVE-006.
Updated Cohort 4 data from the GOBLET study show median duration of response of about 15 months in second-line or later squamous cell anal cancer, with median overall survival not yet reached.
The company says all five patients tested PCR-negative after tafenoquine-based combination therapy, and plans a pre-sNDA FDA meeting after unblinding its randomised hospital study in January 2027.
The draft introduces existing resources for electronic IDE submissions; binding standards, a timetable and exemption criteria are due only when the guidance is finalised.
CBER's updated guidance page lists documents issued between July and October 2026, including a draft on individualised human genome editing products and blood donor compliance policies.
FDA has posted the agenda and slides from its 26 October meeting on proposed recommendations for renewing the Biosimilar User Fee Act, with a docket open for comments.
CBER's guidance listing for cellular and gene therapy products shows seven 2026 entries, the latest a draft on individualized genome editing products dated October 2026.
Ravimiamet's October 2026 overview of veterinary approvals lists one product: Bioveta's BioBos BTV 3 injectable suspension, authorised on 26 October with a one-year validity.
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.