Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The US ophthalmic company held its full-year sales guidance, lowered its profit outlook to above $40 million, and brought forward its planned G-MELT NDA submission to 2026.
The oral biologics developer also reported $45.3 million in cash at the end of Q3 2026, which it expects to fund operations through at least the end of 2027.
The company now expects 2026 revenue of $337–351 million and adjusted EBITDA of $176–190 million, citing the Jazz milestone, the Theravance acquisition and the Roche ZW209 licence.
Translational analysis from a Phase 1b/2 combination trial points to antigen-presenting activity and CD8 effector memory T-cell expansion, with a poster due at ASH on 12 December.
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 European Medicines Agency has released a document setting out pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026.
The medical device maker reported third-quarter net sales of $207.9M and an adjusted EBITDA of $26.0M, while U.S. spine sales fell 4.3%.
Mereo BioPharma says it is still consulting regulators with Ultragenyx on a setrusumab filing path, while cash of $26.1 million is expected to last into late 2027.
CorMedix will acquire substantially all of Heron's assets, including ZYNRELEF, APONVIE, CINVANTI and SUSTOL, for cash, shares and contingent earn-outs, with closing expected in Q1 2027.
CorMedix has agreed to buy substantially all of Heron's assets, including four hospital-use products for postoperative pain and nausea and vomiting, with closing expected in the first quarter of 2027.
Initial Phase 1/2 results for the allogeneic CD19-targeted CAR NK therapy support a compressed Day 0/2/4 dosing schedule, and the company plans FDA talks on a registrational path.
The US company reported $35.1M in third-quarter revenue, a net profit of $7.0M and $104.3M in cash with no debt, and said HEPZATO is now at 33 active centres.
The Simoa maker reported third-quarter revenue ahead of expectations and set out neurology assay launches, a 2027 IVD submission plan for HD-X and updated 2026 guidance.
Laboratory data for APVO451, APVO452 and APVO711 were shown at SITC on 7 November; the company expects two molecules to enter IND-enabling studies in 2027.
Whitehawk Therapeutics said its biparatopic antibody drug conjugate for small-cell lung cancer has entered a US Phase 1 trial, as it reported Q3 2026 results with $169.7 million in cash.
Neurogene says the primary analysis of its NGN-401 Embolden trial will include every dosed participant, with topline results expected in the second half of 2027 and PPQ runs due by year-end.
The company completed an $86.6 million PIPE and amended its royalty and loan agreements in October, while partner Tanabe Pharma filed for Zynlonta approval in Japan.
The company still intends to seek FDA accelerated approval of tralesinidase alfa for MPS IIIB in December, while restructuring its debt and separating its CRHX-101 programme.
Topline Part B results for VDPHL01 show hair-count gains in over 500 men, with no treatment-related serious adverse events or cardiac events of special interest.
ImmunityBio says the FDA has broadened Anktiva's indication to include papillary-only tumours, as quarterly net product revenue rose 53% to $48.7 million.
The CRO has signed definitive agreements for the Pennsylvania units, with up to $75m in further performance-based payments, through a consortium structure that first takes Frontage private.
The Nasdaq-listed vaping technology company reported a year-on-year revenue decline, citing weaker European sales linked to tighter vaping regulation, while Adjusted EBITDA turned positive.
The 600 mg dose beat placebo on ACR20 at Week 28, but 300 mg did not separate; Immunovant also says further Sjögren's development beyond Phase 2 looks unlikely.
Edesa Biotech grants Kyorin Pharmaceutical exclusive Japanese rights to its anti-TLR4 antibody for acute respiratory distress syndrome, with $12m upfront and further milestones and royalties.
Tonix says third-quarter TONMYA net sales rose 37% on the prior quarter, while Dr. Reddy's has filed an ANDA with a Paragraph IV certification and the company plans to enforce its patents.
The company reports a statistically significant efficacy gain over BCG alone in Cohort A of QUILT-2.005 and plans a supplemental BLA filing by the end of 2026.
After FDA discussions and ESMO data showing an 82% response rate in later-line disease, Tango plans a front-line trial in MTAP-deleted pancreatic cancer in the first half of 2027.
The US cell therapy developer expects eGFR-slope topline data from the PROACT 1 trial in mid-2027 and plans an accelerated approval submission the following year.
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.
Phase 1/2 data at ACR Convergence 2026 show durable responses across myositis, lupus nephritis and systemic sclerosis, with a low rate of severe cytokine release syndrome.
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.