What the Veradermics Phase 3 results mean for oral minoxidil treatment
Veradermics reports strong Phase 3 VDPHL01 hair growth results in 536 men. Efficacy is encouraging, but safety and FDA review remain crucial.
Pharma & Biotech
Pharma & Biotech
United Therapeutics advances SUMMIT study targeting pulmonary hypertension in COPD
United Therapeutics secures FDA clearance for its SUMMIT PH-COPD trial. Can a new treprostinil inhaler overcome earlier safety concerns?
Pharma & Biotech
Zydus gains regulatory milestone in $31.7bn Keytruda biosimilar market
The FDA has accepted FYB206, a proposed biosimilar to Merck's Keytruda, for review, with a decision potentially due in the third quarter of 2027. Zydus and Formycon pursued a streamlined development programme without a comparative Phase 3 efficacy trial, but approval, patent clearance and commercial launch remain separate hurdles.
Medical Devices & Diagnostics
Vantis expands CrossFAST to handle IVUS and lithotripsy. Can it simplify complex heart procedures?
Vantis Vascular has received FDA 510(k) clearance for a 6F version of its CrossFAST delivery system, expanding compatibility with intravascular imaging and calcium-modification devices. The November launch builds on encouraging early clinical experience, although comparative evidence remains limited.
Medical Devices & Diagnostics
CSQ Bio’s collagen powder turns into a wound-covering gel. Can it win over US surgeons?
CSQ Bio has established a surgical commercialization business and introduced INNESTO Rx, a bovine collagen powder scheduled for US sales in January 2027. The product uses an existing FDA-cleared device platform, but clinical differentiation, reimbursement and distribution economics remain unproven.
Pharma & Biotech
Avenzo Therapeutics to reveal VBC103 Phase 1 results at ESMO Asia 2026
Avenzo's partner VelaVigo will disclose early human safety and efficacy findings for the Nectin-4/TROP2 antibody-drug conjugate VBC103 at ESMO Asia 2026. The presentation could clarify the clinical potential of dual-antigen targeting, while a separate United States study advances in urothelial cancer.
Pharma & Biotech
GC Biopharma expands ALYGLO safety evidence amid growing US immunoglobulin sales
GC Biopharma will present expanded aggregation testing across 18 lots of five IVIG products and a new review of ALYGLO Phase 3 safety data. The analyses identify measurable molecular differences and provide additional safety context, but neither establishes comparative clinical superiority.
Pharma & Biotech
T-MAXIMUM’s off-the-shelf CAR-T shrank brain tumors in early testing. Can Phase 2 confirm the signal?
T-MAXIMUM has received FDA clearance to initiate a Phase 2 study of MT027 in brain metastases from lung and breast cancer. Early results in a small lung cancer cohort support further investigation, but clinical efficacy, neurological safety and manufacturing scalability remain unproven.
Medical Devices & Diagnostics
How the da Vinci SP system is changing selected breast cancer surgery workflows
MedStar Georgetown combines four breast procedures through one 4-centimeter robotic incision. Examine safety, sensation and clinical evidence.
Pharma & Biotech
Amphista Therapeutics begins first human trial of AMX-883 BRD9 degrader in acute myeloid leukemia
Amphista begins its 54-patient AMX-883 Phase 1 trial in AML and high-risk MDS. Examine the novel BRD9 mechanism, safety tests and next milestones.