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The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.

September 24 is World Cancer Research Day, and September is Childhood Cancer Awareness Month. BioSpace spoke with leaders from three companies tackling pediatric glioma.

Recently published research into repairing nerve damage caused by injury may also pay off in treating some of the most vexing neurodegenerative diseases like Alzheimer’s.

NovoCure announced the launching of a U.S.-based arm to focus on and attempt to grow its glioblastoma (GBM) business and increase its patient population.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-2 against Oncopeptides’ Pepaxto, a drug that has been on the market since 2021 for multiple myeloma under accelerated approval.

The FDA will meet Friday to discuss the future of Secura Bio’s Copiktra (duvelisib), which has been approved as a third-line treatment for relapsed or refractory CLL/SLL.

This week, researchers delivered insights and breakthroughs in regenerative medicine, Long COVID, immuno-oncology and inflammatory diseases.

Merck announced positive results on its patent infringement case against Viatris, while Amgen faces political headwinds from the White House.

One-year data indicates Biogen’s tofersen for SOD1-ALS, slows the decline of the disease through the lowering of SOD1 protein and neurofilament levels.

AstraZeneca has decided to drop the hypercholesterolemia candidate AZD8233 through to Phase III, despite meeting its Phase IIb primary efficacy endpoint, its partner Ionis announced Friday.

The U.S. FDA had a busy week with a range of drug approvals, advisory committee meetings and classification announcements.

Advances in immuno-oncology and adaptive cell therapy that began about a decade ago are enabling fresh, biology-driven approaches to bring therapeutic cancer vaccines closer to fruition.

Expanded sweetener molecule development program aims to broaden access to plant-based sweetening solutions tailored to diverse customer food and beverage categories.

• $5.5 million financing that closed on April 2, 2026 together with $5.7 million in capital raised in Q1-2026, expected to provide Company with cash runway into 2027 • $4.5 million of accrued VAT refunds and R&D refundable tax credits from UK subsidiary begin maturing, including $1.9 million VAT cash refund expected in June 2026 • Successful EMA and Australia TGA (ATGA) meetings aligned around use of existing biomarker and pending release of 3-year overall survival data to support Conditional Marketing Authorisations (CMAs) for OST-HER2 in prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma (“Metastatic Osteosarcoma”) • 2.5-year overall survival data expected to be released during ASCO 2026 • EMA and ATGA have aligned on key design aspects of confirmatory Phase 3 Metastatic Osteosarcoma protocol required to have commenced prior to grant of CMAs or FDA BLA, including alignment on 3-year overall survival as a primary clinical efficacy endpoint • Upcoming U.S. FDA Type C meeting and U.K. MHRA SAM meeting to align with EMA & ATGA prior to Australia Clinical Trial Notification submission for Phase 3, including alignment on 3-year overall survival as a primary clinical efficacy endpoint. U.S. FDA (“FDA”) Pre-BLA meeting to confirm alignment on surrogate and primary clinical efficacy endpoints with EMA/ATGA, including alignment on 3-year overall survival as a primary clinical efficacy endpoint, and seek decisions on rolling review acceptance and RMAT designation following the EMA and U.K. MHRA granting ATMP designation (EMA/MHRA RMAT equivalent) for OST-HER2 in Metastatic Osteosarcoma • OS Animal Health S-1 filing for proposed ‘Go-Public’ transaction and receipt of SEC comments