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Jun 21, 2026
Cantargia reported full year 2025 financial results with net sales of SEK 316.7 million and cash of SEK 281.8 million. The company secured a SEK 124 million financing package to advance clinical development of nadunolimab, including a phase Ib study combining it with a RAS inhibitor in pancreatic cancer.
Jun 21, 2026
The FDA now allows "no artificial colors" labeling claims for foods without FD&C-certified synthetic colors, part of federal efforts to transition away from petroleum-based dyes. The agency approved beetroot red and expanded spirulina extract uses while initiating a safety review of preservative BHA.
Jun 20, 2026
The FDA reversed its initial rejection of Moderna's mRNA flu vaccine, agreeing to a normal review after public backlash, while a federal judge invalidated the ACIP advisory committee, leaving the US without functioning vaccine oversight. Moderna's vaccine showed 26.6% greater efficacy than standard flu shots in clinical trials.
Jun 19, 2026
An FDA advisory panel unanimously recommended approval of Moderna's mRNA flu vaccine mFlusiva for adults 50 and older. The vaccine showed a 27% reduction in flu cases versus a standard shot. A final FDA decision is expected by early August.
Jun 19, 2026
Clinical trials are offering new options for cancer patients, with some achieving long-term survival even with advanced disease. Precision medicine programs are expanding access to these trials by identifying patients with specific tumor mutations, reshaping oncology care.
Jun 19, 2026
Allarity Therapeutics will present a Trial-in-Progress poster at the ESMO Gynaecological Cancers Congress 2026 on its Phase 2 ovarian cancer trial of stenoparib. The company also dosed first patients in February 2026 in a VA-funded Phase 2 trial of stenoparib plus temozolomide for relapsed small cell lung cancer.
Jun 18, 2026
The FDA has reversed its earlier rejection of UniQure's Huntington's disease therapy AMT-130, accepting existing trial data for accelerated review. The company plans to submit a marketing application in Q3 2026, ending a dispute over sham surgery requirements.
Jun 18, 2026
Ocular Therapeutix stock surged 30% in premarket trading as the company prepared to release topline Phase 3 data for AXPAXLI in wet AMD. The SOL-1 trial results will be presented at the Macula Society meeting later in February. The company plans to file for FDA approval using one-year data if results are favorable.
Jun 18, 2026
The FDA issued final guidance advising drug companies to set duration limits for medically important antibiotics in livestock feed without legal obligation. Public health advocates criticize the guidance as insufficient to combat antibiotic resistance, which causes over 2.8 million infections and 35,000 deaths annually in the U.S.
Jun 17, 2026
NMD Pharma reported Phase 2a trial data showing ignaseclant improved muscle strength and motor function in adults with Charcot-Marie-Tooth disease, with benefits lasting seven days after treatment. The study met key secondary endpoints but missed its primary endpoint of six-minute walk test improvement. The drug has received FDA orphan drug designation for CMT.
Jun 17, 2026
The FDA agreed uniQure's existing trial data could support an accelerated approval filing for Huntington's therapy AMT-130, a reversal from earlier positions. Meanwhile, UK-based Harness Therapeutics selected HRN001 as its lead experimental candidate, targeting the FAN1 protein to address somatic expansion of Huntington's-causing genetic repeats.
Jun 16, 2026
Acurx Pharmaceuticals is advancing ibezapolstat to international Phase 3 clinical trials for C. difficile infection following final regulatory guidance from FDA and EMA. The company launched a new clinical trial program for recurrent CDI and presented structural biology research demonstrating ibezapolstat's mechanism of action. Acurx reported year-end 2025 cash of $7.6 million.
Jun 17, 2026
The FDA has approved WAKIX for cataplexy in pediatric narcolepsy patients, making it the first non-scheduled treatment for all ages. Harmony Biosciences reported 2025 WAKIX revenue of $868.5 million and projects 2026 sales over $1 billion, nearing blockbuster status.
Jun 16, 2026
Sensei Biotherapeutics has changed its name to Faeth Therapeutics following its February 2026 acquisition of the biotechnology company. The name change accompanies a $200 million private placement financing to advance PIKTOR, an investigational all-oral multi-node inhibitor targeting the PI3K/AKT/mTOR pathway in endometrial and breast cancer. Topline Phase 2 data in endometrial cancer is anticipated in the second half of 2026.
Jun 16, 2026
The FDA has approved three new targeted therapies for different stages of advanced prostate cancer: Truqap for PTEN-deficient tumors, rucaparib for BRCA-mutated castration-resistant disease, and Akeega for BRCA2-mutated castration-sensitive cancer.
Jun 16, 2026
The U.S. FDA has accepted Gilead's application for an investigational once-weekly oral lenacapavir for HIV prevention, with a review date set for February 2027. Concurrently, PEPFAR and The Global Fund are expanding access to the twice-yearly injectable version to a total of 3 million people by 2028. Gilead will present new data on both lenacapavir and a novel bictegravir/lenacapavir combination at CROI 2026.
Jun 16, 2026
Grifols has launched FESILTY (fibrinogen, human-chmt) in the U.S., a fibrinogen concentrate FDA-approved in December 2025 for acute bleeding episodes in patients with congenital fibrinogen deficiency. The highly purified product, developed by Biotest, enables rapid fibrinogen restoration and can be reconstituted in approximately three minutes.
Jun 15, 2026
The FDA has granted accelerated approval to Denali Therapeutics' Avlayah (tividenofusp alfa-eknm), the first therapy targeting neurological symptoms of Hunter syndrome. The approval was based on a surrogate endpoint measuring heparan sulfate reduction in cerebrospinal fluid, with confirmatory study results required for full approval. The global Hunter syndrome treatment market is projected to reach $2.6 billion by 2033.
Jun 15, 2026
The FDA has cleared an IND for Amphista's novel BRD9 degrader AMX-883 for AML, approved Lantheus' new prostate cancer imaging agent Pylarify TruVu, and accepted Biofrontera's sNDA for Ameluz PDT in superficial basal cell carcinoma. These regulatory milestones span hematologic and solid tumor areas, addressing significant unmet medical needs.
Jun 15, 2026
New research shows posture-driven retinal vascular changes can predict diabetic retinopathy progression, with smartphone-based imaging detecting early microvascular dysfunction. A five-year study found abnormal arteriolar tortuosity during postural shifts increased progression risk over two-fold.
