Curated news and analysis on clinical trials, drug approvals, and medical research.
Dianthus, Taysha and aTyr disclosed inducement equity grants for newly hired employees under Nasdaq Listing Rule 5635(c)(4), detailing share awards, vesting schedules and exercise prices.
Laguna won FDA Breakthrough Device Designation for a blood-based schizophrenia test, while Neurocrine dosed the first patient in a Phase 2 trial of NBI-1117570.
Vermont insurers and employers are scaling back GLP-1 coverage as costs rise, leaving some patients without access. The drugs remain in high demand as studies point to benefits beyond weight loss.
Guardant Health said its chief medical officer will resign effective May 8, while Delfi Diagnostics appointed Charles Newton to its board and Singular Genomics named John Stark CEO.
Pfizer reported new clinical and regulatory milestones across oncology, obesity and hemophilia, including BREAKWATER Phase 3 data and Priority Review for HYMPAVZI. The company also cited MagnetisMM-5 results and FDA priority review for PADCEV.
The Fifth Circuit reinstated an in-person dispensing requirement for mifepristone, blocking telemedicine prescriptions. The ruling came after a federal judge paused Louisiana's lawsuit pending the FDA's safety review of the abortion medication.
FDA released its 2026 Rare Disease Hub Strategic Agenda and a draft guidance on 3-year New Clinical Investigation Exclusivity. The agency also outlined new pathways including the plausible mechanism pathway and Rare Disease Evidence Principles to accelerate treatments for rare diseases.
FDA launched two proof-of-concept real-time clinical trials on April 28, 2026, and issued an RFI for an AI-focused pilot program to optimize early-phase trials. The agency aims to reduce gaps between trial phases and modernize drug development.
Phase 3 trial data show daratumumab reduced relapse risk by 74% in NMOSD. Separately, the FDA accepted an NDA for iberdomide plus daratumumab/dexamethasone in relapsed/refractory multiple myeloma, with a PDUFA date of August 17, 2026.
Two studies identify protein recycling dysfunction and transcription factors ZSCAN20/JDP2 as drivers of T-cell exhaustion, with E3 ligases and gene deactivation offering reversal pathways. A third study finds TCF1 insufficient to revert terminally exhausted T cells.
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
FDA grants Priority Review for Gilead's bictegravir/lenacapavir single-tablet HIV regimen. The NDA is supported by ARTISTRY-1 and ARTISTRY-2 trials showing noninferiority. A PDUFA target date of August 27, 2026 has been set.
European biotechs are exploring new immunotherapy targets beyond PD-1/PD-L1, including BTLA, TIGIT, and SLAMF6. Lund University researchers discovered a SLAMF6-mediated immune evasion mechanism. BioNTech and GenMab are advancing next-generation ICIs and bispecific antibodies through strategic partnerships.
Aurobindo Pharma's subsidiaries secured Health Canada approval for bevacizumab biosimilar Bevqolva, an EU distribution deal with STADA for two EMA-approved biosimilars, and US FDA approval for ADQUEY ointment for atopic dermatitis.
India has eased Press Note 3 FDI rules with a beneficial ownership test, 10% safe harbour for non-controlling LBC investments, and 60-day fast-track approvals in seven manufacturing sectors. The revised norms aim to clear 600 pending applications and boost gross FDI to $90 billion in FY26.
FDA's ODAC voted 6-3 against AstraZeneca's camizestrant for HR+/HER2- metastatic breast cancer, citing uncertain clinical benefit from the SERENA-6 trial design. The FDA raised concerns about the early-switch treatment paradigm and long-term outcomes.
Ray Therapeutics received EMA PRIME designation for its RTx-015 optogenetic gene therapy for retinitis pigmentosa, following recent FDA RMAT status. The company also appointed Michael Murtagh as Chief Regulatory Officer to support global development.
Crescent Biopharma dosed the first patient in its ASCEND Phase 1/2 trial of CR-001, a PD-1 x VEGF bispecific antibody for solid tumors. The company also reported Q1 2026 results and outlined pipeline milestones including ADC combination trials expected in the second half of 2026.
Researchers identify DPY30 as an epigenetic target to sensitize pancreatic tumors to immunotherapy. UC San Diego researchers redirect CMV immunity against pancreatic cancer in preclinical models. A Fred Hutch researcher receives ACS grant to study immunotherapy resistance in melanoma.
MIT chemical engineers used a large language model to optimize protein production in industrial yeast. The AI model improved yields for five of six tested proteins, including a cancer monoclonal antibody, potentially reducing drug development costs.
