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Jul 10, 2026
Australian and US regulators have warned about sexual enhancement and honey products containing undeclared prescription medicines, prompting recalls and safety alerts. UK regulators also caution about underreported drug-herb interactions and herb-induced liver injury.
Jun 15, 2026
Disc Medicine received an FDA Complete Response Letter for bitopertin over PPIX. It plans to complete APOLLO enrollment by March 2026, with topline data in Q4 2026 and a decision targeted by mid-2027.
Aug 07, 2026
BioMarin reported Q2 2026 revenues of $990 million, up 20% Y/Y, and raised guidance. It filed an sNDA for VOXZOGO in hypochondroplasia and advanced BMN 333, BMN 820, and BMN 351.
May 05, 2026
TuHURA Biosciences filed an FDA IND for TBS-2025, a VISTA-targeting antibody, plus a menin inhibitor in mutNPM1 r/r AML. Phase 2 targets early Q2 2026 with preliminary Stage 1 results in Q3 2026.
Aug 08, 2026
Lupin reported record Q3 FY2026 revenue of INR 7,168 crores and a 31.1% EBITDA margin, while preparing to launch a generic semaglutide and shifting focus to innovation. The company also secured US FDA approval for Pegfilgrastim and EU approval for ranibizumab biosimilar.
Jul 24, 2026
The European Medicines Agency is enforcing clinical trial transparency and has launched a new vaccine information initiative, while a coalition of health professionals warns of suboptimal vaccination coverage across Europe. An analysis also shows that only a portion of EMA-approved medicines are available to NHS patients in England after additional assessments.
Jul 09, 2026
OS Therapies achieved FDA, MHRA, EMA and TGA alignment on the Phase 3 design for OST-HER2 in osteosarcoma. The confirmatory trial must start before BLA grant and is expected in Q3 2026.
Aug 08, 2026
FDA issued EUAs for Dectomax and CLiK Extra against New World screwworm. Dectomax is for prevention/treatment in dairy cattle, swine, horses, sheep, deer. CLiK Extra prevents myiasis in livestock, camelids, wildlife.
Jul 23, 2026
The Supreme Court will hear Hikma's appeal in the 'skinny label' patent fight over Amarin's Vascepa. The ruling could affect generic drug competition and investment in new drug indications.
Jul 27, 2026
Novartis beat second-quarter profit expectations as Kisqali, Kesimpta and Leqvio offset a 50% plunge in Entresto sales. The Swiss drugmaker maintained its full-year guidance and awaits late-stage data on three experimental drugs.
Jul 21, 2026
The FDA moved to exclude semaglutide, tirzepatide and liraglutide from its 503B compounding list. Eli Lilly won U.S. approval for its oral pill Foundayo, and Novo Nordisk sued Lilly over allegedly misleading weight-loss ads.
Jul 10, 2026
The SEC is pursuing insider trading cases involving inadvertent tips of MNPI, including a cousin who traded on confidential FDA approval news and a family member with workspace access during an acquisition.
Aug 05, 2026
Federal courts are weighing whether the April 2026 marijuana rescheduling order was lawful. MMJ argues the Attorney General skipped required rulemaking; DEA testimony flagged omitted diversion analysis. A stay motion is pending.
Jul 22, 2026
A large clinical trial found that adding apalutamide to hormone therapy before and after prostate cancer surgery improves outcomes for high-risk patients. NHS England will roll out SABR radiotherapy requiring only five sessions, and new ctDNA and robotic biopsy technologies are advancing prostate cancer care.
May 28, 2026
Anterior raised $40M to accelerate health plan AI adoption, bringing total funding to $64M. Other deals include Findhelp's $250M investment, Grow Therapy's $150M Series D, and Bexorg's $23M Series A.
Aug 06, 2026
Ivermectin is being promoted again for unproven uses like cancer and hantavirus, while several states consider making it available over the counter. Experts stress there is no clinical evidence for these uses and warn of serious side effects. Prescriptions among cancer patients have more than doubled.
Jul 01, 2026
The FDA approved the first posterior motion-preserving device for degenerative disc disease, while DiscGenics, Angitia, and BioRestorative advanced late-stage trials. ReGelTec reported positive HYDRAFIL data and CE Mark approval.
Aug 04, 2026
Precision diagnostics and medicine market is projected to reach USD 345.75 billion by 2035, while US personalized medicine is set to surpass US$ 307 billion by 2033. AI, single-cell analysis, and clinical laboratory markets also show strong growth.
Jul 20, 2026
The FDA approved Orca-T (Tregzi) for matched donor hematopoietic stem cell transplantation in adults with hematologic malignancies. Phase 3 Precision-T data showed reduced graft-versus-host disease across leukemia and MDS populations, with experts calling it a 'big advance' requiring further comparison with post-transplant cyclophosphamide.
Jun 02, 2026
Gene editing repaired a Dravet syndrome mutation in mice, a prenatal hemophilia A therapy showed maternal safety in sheep, and researchers advanced toward a genetic test for valproic acid use in pregnancy.
