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Jul 17, 2026
The global personalized medicine market is projected to grow from $789.39 billion in 2026 to $1.4 trillion by 2035, driven by genomic sequencing and companion diagnostics. North America leads with 46% of implementation, and AI-assisted interpretation is increasingly integrated.
Jul 17, 2026
The FDA accepted Camurus' NDA resubmission for Oclaiz in acromegaly, setting a December 2026 PDUFA date. The filing follows a June 2026 Complete Response Letter related to third-party manufacturing, with no safety or efficacy issues. Oclaiz is a once-monthly subcutaneous octreotide already approved in the EU as Oczyesa.
Jul 16, 2026
Moderna awaits an August 2026 FDA decision on its mRNA flu vaccine while expanding into oncology, autoimmune disease, and monkeypox. Its COVID-19 vaccine Spikevax remains central amid financial losses and cautious analyst sentiment.
Jun 13, 2026
Belite Bio has begun a rolling NDA submission for tinlarebant, an oral therapy for Stargardt disease type 1. The drug has Breakthrough Therapy Designation, and the company expects to complete the submission in Q2 2026.
Jul 15, 2026
Prime Medicine receives a Buy upgrade from H.C. Wainwright after New Zealand clears its first in vivo prime editing trial for Wilson's disease. The FDA also granted RMAT designation to its CGD therapy PM359. Jacob Funds and ARK Investment have recently added to their positions in the gene-editing company.
Jul 15, 2026
A preclinical study shows that the anti-epileptic drug levetiracetam can prevent the formation of amyloid-beta 42 in neurons by modulating synaptic vesicle recycling. Analysis of patient records indicates a modest delay in cognitive decline among Alzheimer's patients taking the drug, suggesting potential for very early preventive use.
Jul 14, 2026
Acurx Pharmaceuticals announced that ibezapolstat preserves beneficial gut microbes in multiply-recurrent C. difficile infection and outperforms standard antibiotics in biofilm killing. A pilot trial in rCDI is set to begin, with plans for FDA approval under the Limited Population Pathway if successful.
Jul 14, 2026
Cardiol Therapeutics announced the publication of its Phase II MAvERIC study results in the Journal of the American Heart Association. The study showed CardiolRx led to rapid and sustained reductions in pericarditis pain and inflammation with a favorable safety profile. The findings support the ongoing Phase III MAVERIC trial.
Jul 15, 2026
Four biomarkers—MMR, HER2, PD-L1, and Claudin 18.2—are now validated for advanced esophageal cancer, guiding immunotherapy and targeted treatment decisions. Checkpoint inhibitors show clear benefit in MSI-H and PD-L1-positive subgroups, with long-term survival observed. NCCN guidelines recommend broad testing to personalize therapy.
Jul 14, 2026
Nationwide FDA recalls include generic Adderall XR (mix-up), levothyroxine (subpotent), Gas-X (coolant contamination), and several prescription drugs classed as Class II. Moringa dietary supplements are under Class I recall due to serious health risks. Consumers are advised to check lot numbers and consult pharmacists.
Jul 13, 2026
Aquestive Therapeutics disclosed FDA deficiencies in its Anaphylm NDA, halting labeling discussions and causing a 37% stock drop. The setback does not represent a final rejection, leaving a path for resubmission.
Jul 13, 2026
The FDA accepted Bristol Myers Squibb’s NDAs for iberdomide and mezigdomide, two CELMoD agents for relapsed/refractory multiple myeloma. Iberdomide has Priority Review and a PDUFA date of Aug. 17, 2026; mezigdomide’s is May 13, 2027. The filings are backed by Phase 3 data, including a 52% PFS risk reduction for mezigdomide.
Jul 13, 2026
Newron Pharmaceuticals has had a constructive FDA meeting about the clinical hold on its evenamide Phase III ENIGMA-TRS 2 trial and also secured up to €38 million in funding to advance the program. The company plans to propose changes to address the FDA’s concerns, while the financing extends its cash runway beyond key 12-week results.
Jul 13, 2026
Serina Therapeutics completes sentinel dosing in Cohort 1 of its Phase Ib registrational trial of SER-252 for advanced Parkinson's disease. Safety review recommends continuation; enrollment and dosing ongoing. FDA alignment on 505(b)(2) pathway and registrational status.
Jul 11, 2026
The GE HealthCare-Mayo MI-BET collaboration advances biomarker-guided prostate cancer therapy. The precision oncology market, valued at $122.6B in 2025, is projected to reach $317.2B by 2034, fueled by genomics and targeted treatments.
Jul 12, 2026
Savara resubmits BLA with near-term FDA decision expected; Sarepta reports $331M in Q1 net product revenue but Elevidys sales continue to decline; AstraZeneca stock falls ahead of July 2026 earnings release.
Jul 10, 2026
FDA approved subcutaneous isatuximab-irfc for multiple myeloma. Phase 3 EMN24 trial showed 77% MRD negativity with Isa-KRd quadruplet therapy. Phase 2 study showed 77% hematologic response rate in relapsed/refractory AL amyloidosis.
Jul 10, 2026
Keenova's Xiaflex met its primary and secondary endpoints in a Phase 3 trial for plantar fibromatosis. The company plans to file for FDA approval before year-end. A separate real-world evidence manuscript highlighted the lack of approved nonsurgical options for the condition.
Jul 10, 2026
Phase III data show deramiocel slowed upper limb decline by 54% in Duchenne muscular dystrophy. The FDA is re-evaluating the BLA with HOPE-3 results, with a submission of the clinical study report expected in February 2026.
Jul 09, 2026
Longeveron's DMC recommended completing the Phase 2b ELPIS II HLHS trial with no safety concerns; top-line results expected August 2026. The company also appointed a new CEO and announced cost-cutting measures.
