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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.

TOP STORIES
The FDA on Thursday rejected Merck and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate patritumab deruxtecan in a Complete Response Letter, citing problems with a third-party manufacturer.
Industry experts provide clinical trial design and protocol suggestions for psychedelic drug developers after an advisory committee voted against approving Lykos’ MDMA-assisted PTSD therapy.
New recommendations from the Centers for Disease Control and Prevention call for the use of respiratory syncytial virus vaccines in adults aged 75 and older, but limited its use in 60- to 74-year-olds.
FDA
AbbVie and Genmab on Wednesday announced the FDA has expanded the label of their bispecific antibody Epkinly, allowing it to be used in patients with relapsed or refractory follicular lymphoma.
FDA
Verona Pharma on Wednesday secured the FDA’s approval for Ohtuvayre, which the company contends is the first inhaled chronic obstructive pulmonary disease medicine with a new mechanism of action in over 20 years.
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Zealand Pharma is looking to build on last week’s positive Phase Ib trial results by raising around $1 billion in a public offering, with the proceeds being used to advance its obesity candidates.
The biotech incubator said Wednesday the majority of the fund will be for clinical proof-of-concept studies, bringing the total funds raised by Curie.Bio to nearly $1 billion.
One patient died of respiratory failure in a Phase I study of Lyell Immunopharma’s investigational CAR-T therapy. The company on Wednesday said it has not definitively linked the fatality to the treatment.
Teva Pharmaceuticals has settled years of tax litigation with the Israel Tax Authority for $750 million, which the company will pay in installments starting in 2024 to 2029.
Following in the footsteps of Sanofi and Moderna, Eli Lilly on Tuesday inked a collaboration agreement with OpenAI to develop novel antimicrobial agents against drug-resistant pathogens.
After back-to-back failures in 2021, Wave Life Sciences has finally aced a Phase Ib/IIa Huntington’s disease trial and is looking to a potential accelerated approval for its investigational antisense oligonucleotide.
UPCOMING EVENTS
PRESS RELEASES
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
MARKET RESEARCH REPORTS