Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The recall, numbered D-0091-2027, is ongoing and covers product distributed across the United States, according to the FDA's enforcement report.
Abc Compounding Co., Inc.'s PRO CHEM BAN AID is the subject of an ongoing, nationwide Class II drug recall citing deviations from current good manufacturing practice.
The recall, numbered D-0080-2027, is ongoing and covers distribution nationwide within the US after a product failed impurities and degradation specifications.
Macleods Pharma USA's olmesartan medoxomil recall, numbered D-0077-2027, is ongoing and covers nationwide distribution in the United States, according to the FDA enforcement report.
The ongoing nationwide US recall, numbered D-0104-2027, was listed in the FDA enforcement report dated 4 November 2026 and cites deviations from current good manufacturing practice.
The nationwide recall of Wechem Hand Guard 8/1000mL Bag, recorded as D-0103-2027, is listed as ongoing in the FDA enforcement report dated 4 November 2026.
The US obesity drug developer reported Q3 results, saying it has $1.04bn in cash expected to fund operations into mid-2028.
Summit Therapeutics says the FDA has set a 14 November 2026 PDUFA date for ivonescimab in EGFR-mutated NSCLC, with the regulator requiring statistically significant overall survival.
The US life-sciences supplier reported third-quarter revenue of $45.9 million, with TriLink mRNA products up 28%, and raised its full-year revenue and Adjusted EBITDA outlook.
Clinical Diagnostics growth offset a decline in Life Science, while a fair-value change on the Sartorius holding drove GAAP net income of $458.6 million; full-year guidance is unchanged.
The cancer diagnostics company also bought Convergent Genomics, won Medicare coverage for Prosigna and lowered its full-year testing revenue forecast.
The EVO ICL maker reports lower year-on-year net sales for the quarter ended 2 October 2026 and flags label expansions and upcoming presbyopia trials.
The packaging group reported 7% higher quarterly sales of $6.13bn but lowered its adjusted EPS guidance, citing the timing of cost pass-through.
The tobacco leaf and ingredients supplier reported net income of $12.6m, with delayed customer commitments cutting tobacco volumes by about 23%.
The animal health and nutrition company reports an 11% rise in net income to $29.5m, with its guidance still assuming no virginiamycin sales in Brazil.
Topline OPUS-1 data show noninferiority to PCV20 and PCV21 with comparable safety; serotypes 3 and 12F missed a stricter threshold against PCV21.
Mineralys Therapeutics reports a $57.3m third-quarter net loss as the FDA reviews its aldosterone synthase inhibitor NDA, with a PDUFA date of 22 December 2026.
OPKO Health agreed to sell its remaining BioReference diagnostic operations to Labcorp and reported third-quarter 2026 continuing-operations revenue of $65.4 million.
The US drug distributor also extended its CVS Health partnership to 2032, agreed to buy about 49% of Option Care Health and closed its Precision Medicine Group deal.
Sera Prognostics reports Florida as the second state Medicaid programme to cover its preterm birth risk test, while it begins EU certification for a kit-based version.
The heart-valve maker cites TAVR and TMTT growth, several recent FDA and European approvals, and CMS's final updated TAVR coverage determination.
GRAIL says Galleri revenue rose 14% to $37.3 million in Q3 2026, and expects an FDA decision on its multi-cancer blood test by early Q1 2027.
The company posted a $190.1M third-quarter net loss and says it will file for aficamten in non-obstructive HCM in the US this quarter and in the EU in early 2027.
The bioelectronic medicine company narrowed its quarterly loss to $1.3 million and has asked the FDA to clear Quell for chronic chemotherapy-induced peripheral neuropathy.
The company's 4 November webcast covered ASH abstracts and preliminary Q3 2026 figures, while its forward-looking statements cite serious FDA concerns raised at a pre-sBLA meeting.
The company plans to meet the FDA in the first half of 2027 on a possible accelerated approval route for its ENPP3 x CD3 bispecific antibody.
The computational drug discovery company reported a $37.7m quarterly net loss and noted FDA Priority Review for Takeda's zasocitinib NDA in plaque psoriasis.
Dianthus Therapeutics' third-quarter update shows claseprubart beating its CIDP response target at interim, with MMN top-line results expected next month and cash guided into 2030.
Lyell Immunopharma reported updated PiNACLE data in third-line-plus large B-cell lymphoma, with pivotal readout due mid-2027 and a BLA planned for the second half of that year.
Vir's Q3 update reports Fast Track for its PSMA-targeted T-cell engager in prostate cancer, a Gilead deal worth $90 million upfront, and an imminent hepatitis delta Phase 3 readout.
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.