Plants, CDMOs, supply chains, shortages, recalls and warning letters.
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.
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.
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 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.
FDA analysis found the male sexual enhancement product, sold online and via eBay since at least October 2021, contains undeclared sildenafil and acetaminophen; no adverse events have been reported.
Terumo BCT has notified customers using Spectra Optia apheresis systems on software 12.1, with Health Canada noting a possible treatment delay if the AIM system cannot be disabled.
The US gene-editing company also launched a partner-funded Indian Mustard programme and cut nine-month operating cash use by about 19%, to $30.2 million.
Beaver-Visitec International has recalled certain Mini Blades units after finding an intermittent "open seal" condition that means sterility cannot be guaranteed, Health Canada reports.
Siemens Healthineers is issuing a delta-installation hotfix, XB20A-HF02, for seven MAGNETOM Flow.Elite scanners in Canada, addressing coil detection, logging, start-up stability and patient table reliability.
Health Canada has listed a recall of Centricity Universal Viewer software over a vulnerability that could allow unauthorised access to patient data when launched from third-party applications.
Nine General Procedure Tray configurations are affected after Becton Dickinson asked for discontinuation of infusion sets used with the BD Alaris pump module model 8100.
Siemens Healthcare's syngo MR XB10B-HF02 hotfix, covering two MAGNETOM Flow.Elite systems in Canada, addresses coil detection, data logging, start-up stability and patient table reliability.
Coherus Oncology will supply LOQTORZI for a planned US study pairing it with Oncolytics' investigational oncolytic virus pelareorep in squamous cell anal carcinoma.
The company says Type A meeting minutes cited no clinical safety or efficacy deficiencies, and a $10M private placement extends its cash runway through 2028.
A typographical error on the front of the carton misstates the hydrochlorothiazide strength as "12. mg"; the MHRA says the tablets are unaffected and supply should continue.
Teleflex subsidiary Arrow International has told customers to quarantine guidewires and PICC or JACC catheters whose hydrophilic coating may detach and release particles into the bloodstream.
IsoTis OrthoBiologics is voluntarily removing specific Accell Connexus lots in Canada after possible particulate contamination linked to contact between a ball spring and the mixing container during manufacture.
Health Canada lists a Type I recall of the Surfacer system's Workstation Sheath and Dilator after four complaints, two involving adverse events.
Carestation 850 and 850c systems can deliver a lower concentration of anaesthetic agent than intended, according to a Health Canada recall notice for Datex-Ohmeda, Inc.
The list names Abiomed, Dexcom, Medtronic, Siemens and others; its title and description give different months, so teams should check the dates at source.
The US regulator has upgraded the Abiomed action to its most serious category, citing quality issues in heart pump controllers that could delay therapy or cause loss of haemodynamic support.
EOF has ordered the recall of every non-expired lot of the medical device 'Steriflush Syringes NaCl 0.9%', with affected lots listed in a table attached to the decision.
The Israeli biotech's Yavne CDMO operations and an expanded U.S. customer deal drove sales growth, but a one-off accounting gain masks a wider operating loss.
A four-year exclusive deal with minimum purchase commitments covers Israel, with revenue expected from 2027 and talks on HMO reimbursement to follow.
The US sterilisation-assurance supplier issued its first fiscal 2027 guidance and said a September FDA inspection of its Montana biological indicator site closed without Form 483 observations.
Health Canada reports a Type II national recall of Pendopharm's 25 mg and 50 mg diphenhydramine capsules after N-Nitroso-N-Desmethyl Diphenhydramine exceeded specification in seven lots.
The US cell therapy company's SEC-filed corporate deck sets out its CAR-T candidate across five autoimmune diseases, but the excerpt available contains no new data or dates.
The agency's 4 June 2024 digest covers further recalls of China-made plastic syringes, a Cronobacter safety alert for an infant formula, and a CDER explainer on pharmaceutical quality.
Eugia US is recalling one lot of vancomycin for injection to hospital level after a glass particle was identified inside a vial; no adverse events have been reported.
The manufacturer has begun a field safety corrective action after customers reported ammonia calibration results roughly 6% to 15% too low following a switch of standard lots.