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May 02, 2026
FDA released its 2026 Rare Disease Hub Strategic Agenda and a draft guidance on 3-year New Clinical Investigation Exclusivity.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.
May 02, 2026
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.
May 02, 2026
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.
May 02, 2026
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.
May 02, 2026
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.
May 01, 2026
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.
May 01, 2026
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.
May 01, 2026
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.
May 01, 2026
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.
May 01, 2026
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.
Apr 30, 2026
FDA issued guidance on the Food Traceability Rule, finalized an exemption for IMS-listed Grade A cottage cheese, and announced a June 15, 2026 public meeting on lot-level traceability, as Congress bars enforcement funding until July 20, 2028.
Apr 30, 2026
FDA clears Cloudbreak Pharma's IND for CBT-199, a novel presbyopia eye drop, allowing Phase 2 trials to proceed. The company also advances CBT-001 (Phase 3 for pterygium) and CBT-004 (Phase 3 for pinguecula).
Apr 30, 2026
EMA has initiated a rolling review of OS Therapies' OST-HER2 for preventing recurrence in fully resected pulmonary metastatic osteosarcoma. A potential conditional marketing authorization decision is expected in Q4 2026, with a confirmatory Phase 3 trial planned for Q3 2026 in Australia.
Apr 29, 2026
Immunome submitted an NDA to the FDA for varegacestat in desmoid tumors after the Phase 3 RINGSIDE trial showed an 84% reduction in progression risk (HR=0.16) and a 56% objective response rate. The company plans to file in Q2 2026.
Apr 29, 2026
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Apr 29, 2026
FDA approves AstraZeneca's Breztri Aerosphere as the first single-inhaler triple therapy for asthma in patients aged 12+, based on Phase III KALOS and LOGOS trials showing improved lung function and reduced exacerbations versus dual therapy.
Apr 28, 2026
Compass Therapeutics reported mixed Phase 2/3 data for tovecimig in biliary tract cancer and plans to meet with the FDA for a BLA discussion. The study met its primary ORR endpoint (17% vs 5%), while PFS and OS data are due late this quarter.
Apr 28, 2026
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
Apr 27, 2026
GENFIT will receive a $20 million milestone from Ipsen after Iqirvo posted $208 million in 2025 net sales in primary biliary cholangitis. The sales also triggered a €30 million instalment under GENFIT’s royalty-financing deal.
Apr 27, 2026
Kyowa Kirin and Kura Oncology started a Japanese Phase II registrational study of ziftomenib in adults with relapsed or refractory NPM1-mutated AML. Kyowa Kirin plans to seek regulatory approval in Japan after the trial.
