Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The recall, numbered D-0079-2027, covers cinacalcet tablets from Strides Pharma Inc, is ongoing and was distributed across the US.
Pritam International Private Limited's BB (Brush Buddies) Cavity Protection is subject to an ongoing nationwide US recall, classified Class II, citing deviations from current good manufacturing practice.
Pritam International Private Limited's BB (Brush Buddies) Advanced Whitening is subject to an ongoing nationwide US recall, classified Class II for current good manufacturing practice deviations.
The company reported third-quarter revenue of $2.94 billion, lifted its full-year outlook excluding Bausch + Lomb and announced a $50 million share repurchase programme.
The Invisalign and iTero maker reported higher aligner sales but weaker scanner revenue, and said discretionary dental spending remains soft.
The obesity drug developer launched Phase 3 trials of oral VK2735 in obesity and type 2 diabetes, while its subcutaneous VANQUISH studies remain on track to complete in 2027.
Glaukos reported record Q3 net sales driven by iDose TR and the newly approved Epioxa, lifted its 2026 outlook and set a preliminary $1bn target for 2027.
The brain and spine delivery device maker reported higher neurosurgery sales, a thinner gross margin and a first formal BLA submission by a partner in Huntington's disease.
MiMedx's October 2026 investor presentation says its proposed Sanara MedTech acquisition faces an FTC Second Request and HSR waiting period, with Hayfin debt financing committed.
MIMEDX reported $62M in Q3 net sales, down from $114M, while citing a court ruling on AXIOFILL and a $25M patent licence deal.
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.
The presbyopia eye-drop maker reported a 50% quarter-on-quarter sales rise, announced a Q4 reorganisation and filed VIZZ in three more markets, while its CEO steps down on 1 December.
The Nasdaq-listed company will trade as AZR from 29 October, with a new executive team and an oral AhR agonist expected to enter Phase 1 in the first half of 2027.
Vanda Pharmaceuticals reports higher third-quarter product sales and lower spending, while flagging planned sNDA filings, a BYSANTI launch and two FDA milestones in December.
Biogen reported a 49% jump in Growth Portfolio revenue, helped by SYFOVRE and EMPAVELI, and raised the low end of its 2026 non-GAAP EPS guidance.
A Type II recall covers one kit lot of bioMérieux's BIOFIRE BCID2 Panel after complaints of false negatives, linked to unintended movement of pouch chemistry.
Agilent's electronic instructions for three lots wrongly give tissue-section thickness and slide-storage temperature, after hyphens were lost in a formatting change, Health Canada reports.
Siemens Healthineers is rolling out service pack NX VA60A-SP04, a full-installation bug fix, for Magnetom scanners under a Type II recall recorded by Health Canada.
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 document sets out scientific conclusions, grounds for variation, amended Product Information and an implementation timetable for valproate medicines, under reference EMA/PASS/0000287665.
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.
Replimune says its oncolytic HSV-1 therapy, given with nivolumab, became commercially available in early October, with NCCN listing and payer policies emerging while the confirmatory Phase 3 trial enrols.
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.
Amarin posted a slim third-quarter 2026 net profit despite a 20% revenue fall, while partner Recordati began non-reimbursed sales of icosapent ethyl in Poland.
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 Danish Medicines Agency is moving secukinumab (Cosentyx) from dispensing group NBS (derma) to NBS (derma, reuma) for its rheumatology uses.
Ravimiamet says a low price and promised delivery do not make a foreign web shop authorised to sell medicines, and customs detentions of illicit medicines remain high.
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.
Germany's medicines and devices authority has listed an urgent field safety notice for an Inova in vitro diagnostic reagent, with the details contained only in the manufacturer's advisory.
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.