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May 19, 2026
OKYO Pharma said it expanded its Scientific Advisory Board with the appointment of Marta Sacchetti as urcosimod advances in neuropathic corneal pain. The company said urcosimod has Fast Track designation and earlier received a single-patient expanded access IND.
May 19, 2026
The FDA has accepted the New Drug Application for giredestrant plus everolimus in ESR1-mutated, ER-positive, HER2-negative advanced breast cancer. The filing is based on Phase III evERA data showing reduced risk of disease progression or death versus standard-of-care endocrine therapy plus everolimus.
May 19, 2026
The FDA granted Fast Track designation to COYA 302 for ALS. Phase 1 data showed tolerability and biomarker effects, and the phase 2 ALSTARS trial is underway.
May 18, 2026
The FDA pulled back publication of several studies on COVID-19 and shingles vaccines. The blocked studies involved millions of patient records, and two COVID-19 papers were withdrawn in October 2025.
May 18, 2026
Baxfendy was approved in the US for hypertension in adults not adequately controlled on other antihypertensive medicines. The approval was based on Phase III BaxHTN results showing significant systolic blood pressure reductions.
May 18, 2026
The FDA approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic therapies. In TRANSCEND FL, the CAR T therapy showed a 95.5% overall response rate and 62.1% complete response rate.
May 17, 2026
United Therapeutics received FDA clearance under an Investigational New Drug application to begin a clinical trial of its pig-derived UHeart xenotransplant. The Phase 1/2/3 EXPRESS study starts with up to 2 participants.
May 18, 2026
Compass Pathways said COMP360 for treatment-resistant depression retains FDA Breakthrough Therapy designation as it advances in phase 3. A Trump executive order also directs faster federal review of psychedelic drugs with breakthrough status.
May 17, 2026
4D Molecular Therapeutics said 4D-150 is in Phase 3 for wet AMD and nearing Phase 3 in diabetic macular edema. The company reported rapid enrollment, 18-month treatment burden reductions and favorable safety data.
May 17, 2026
TuHURA Biosciences said the FDA granted orphan drug designation to IFx-2.0 for stage IIB to stage IV cutaneous melanoma based on Phase 1 data. The company said its Phase 3 IFx-2.0 study in first-line Merkel cell carcinoma continues to enroll.
May 17, 2026
ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
May 16, 2026
Benitec Biopharma's gene therapy BB-301 improved swallowing ability in all four OPMD patients followed for at least one year in a Phase Ib/II trial. One patient showed continued improvement at two years. The company plans to meet with the FDA in mid-2026 to discuss a pivotal study.
May 16, 2026
FDA approves Genentech's Tecentriq as first ctDNA-guided adjuvant therapy for muscle-invasive bladder cancer, and Venclexta plus acalabrutinib as first all-oral fixed-duration regimen for CLL.
May 15, 2026
Only 17.7% of pediatric anticancer drugs advance to phase 3 trials, and just 12% earn FDA approval within 10 years, compared to 38.7% for adult drugs. The pace of pediatric approvals has accelerated recently, but funding and market size constraints remain.
May 14, 2026
Senti Biosciences completed enrolment in its Phase I SENTI-202 trial in relapsed or refractory AML and said recent data showed deep, MRD-negative durable complete remissions. The company plans FDA talks in the first half of 2026 on a pivotal registration programme.
May 14, 2026
CEL-SCI said it expects to begin summer 2026 enrollment in a 212-patient U.S. confirmatory registration study of Multikine in head and neck cancer. The company also said it submitted a Breakthrough Medicine Designation application in Saudi Arabia and reported quarterly net loss of $5.5 million.
May 14, 2026
The European Commission expanded Hympavzi approval to patients 12 and older with hemophilia A or B with inhibitors. Phase 3 data showed a 93% reduction in mean treated annualized bleeding rate versus on-demand therapy.
May 14, 2026
The FDA cleared neuromodulation devices from Epineuron, Aneuvo and Encora Therapeutics. The products address peripheral nerve surgery, spinal cord injury neurorehabilitation and essential tremor.
May 14, 2026
A U.S. appeals court revived Regenxbio’s patent suit against Sarepta, holding the asserted gene-therapy host cell claims are markedly different from anything occurring in nature.
May 14, 2026
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
