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Aug 24, 2026
Japan's MHLW granted Orphan Drug Designation to three investigational therapies: gildeuretinol for Stargardt disease, QRX003 for Netherton Syndrome, and E2086 for narcolepsy, each offering potential 10-year market exclusivity.
Aug 24, 2026
Everything Sprouts LLC recalled alfalfa sprouts after 55 E. coli and Salmonella illnesses in 15 states. Four people were hospitalized; no deaths were reported. Consumers should discard affected products.
Aug 23, 2026
Alumis reported that 54% of psoriasis patients achieved complete skin clearance (PASI 100) at 48 weeks in the ONWARD3 study, with 75% achieving PASI 90. The company plans to submit an NDA for envudeucitinib in Q4 2026.
Aug 21, 2026
AbbVie will present new lung cancer data at WCLC 2026, including Phase 1b results for ABBV-1480 showing high response rates in NSCLC and safety updates for ABBV-706 in SCLC. The company also reported progress in dermatology, obesity, and Crohn's disease programs.
Aug 21, 2026
New research shows that many people with disease-causing gene mutations never develop illness, challenging traditional assumptions. Studies of 'modifier genes' and genetic outliers are revealing how some individuals stay healthy, potentially leading to new treatments for genetic diseases.
Aug 21, 2026
IceCure Medical's ProSense cryoablation system gains IRB approval for the ChoICE post-marketing study in low-risk breast cancer, with patient enrollment expected soon. Additionally, Thomas Hospital in Alabama becomes the first facility in the state to install ProSense, with procedures starting this month.
Aug 20, 2026
The FDA has declined approval for Disc Medicine's rare disease therapy, which was previously associated with the commissioner's voucher program. The rejection marks a setback for the company's efforts to bring the treatment to market.
Aug 20, 2026
The FDA granted breakthrough therapy designation to subcutaneous amivantamab for recurrent or metastatic HPV-unrelated HNSCC after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The decision was supported by OrigAMI-4 cohort 1 data showing a 45% ORR and 76% clinical benefit rate.
Aug 20, 2026
Longeveron appoints Nirav Jhaveri as CFO, succeeding Marie Washburn. The company anticipates Phase 2b trial results for laromestrocel in HLHS in September, with FDA guidance that a successful trial would be pivotal for BLA filing.
Aug 20, 2026
Merck and Moderna's personalized mRNA cancer vaccine combined with Keytruda significantly reduced melanoma recurrence risk in a Phase 3 trial. The FDA has not yet approved the vaccine, with potential availability expected by early 2027.
Aug 19, 2026
The FDA released draft GDUFA IV and PDUFA commitment letters for FY 2028-2032, proposing domestic manufacturing incentives, new meeting types, and ANDA transparency enhancements. Public meetings are set for September 2026, with comments due in October.
Aug 18, 2026
The FDA approved Lupin's generic pitolisant tablets as bioequivalent to WAKIX, and approved Harmony Biosciences' WAKIX for pediatric cataplexy, making it the first non-controlled treatment for both pediatric and adult narcolepsy patients.
Aug 17, 2026
Acrivon launched a CLIA-certified lab. Eli Lilly disclosed over 5 trillion won in M&A and licensing. Defence Therapeutics named a new radiopharmaceutical COO.
Aug 15, 2026
Valneva withdrew its U.S. BLA and IND for chikungunya vaccine Ixchiq after an FDA clinical hold tied to a serious adverse event. The company reported a wider FY2025 net loss of €115.2 million, while its Lyme vaccine VLA15 showed over 70% efficacy in Phase III.
Aug 14, 2026
Keros Therapeutics plans a phase II DMD trial of rinvatercept in Q1 2026 and regulatory talks for ALS in H2 2026. Cash stands at $383 million with runway into H1 2028.
Aug 14, 2026
FDA approved iberdomide (Zenbexus) with daratumumab and dexamethasone for pretreated myeloma. The EXCALIBER-RRMM trial showed a 41% MRD-negative complete response rate vs 21%.
Aug 13, 2026
FDA cleared Quantum Biopharma's IND for a Phase 2 trial of Lucid-MS in MS. Biogen's BIIB091 Phase 2 trial reached completion, and Bial concluded its ACTIVATE Phase IIb treatment period for GBA-PD.
Aug 12, 2026
IDT's study showed UNCOVERseq achieved 97.6% sensitivity and 78% precision for CRISPR off-target nomination. Scribe will present new data at ASGCT and EAS, including STX-1150. Watchmaker licensed CRISPR-Cas9 IP for NGS normalization.
Aug 11, 2026
Several drugmakers saw shares fall after earnings missed expectations. Alnylam's Amvuttra sales disappointed despite growth; Neurocrine's guidance underwhelmed; AbbVie's Imbruvica and Roche's Vabysmo fell short of consensus.
Aug 11, 2026
First Ascent Biomedical opened a CLIA- and CAP-certified FPM lab in Miami, testing FDA-approved drugs on patient tumor cells with results in ~10 days. Sponsored testing is available for eligible Florida residents and colorectal cancer patients.
