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Although the FDA did not outright say there is a causal secondary malignancy relationship, it asked BMS, Gilead, J&J and Novartis to add warnings to the labels of six CAR-T therapies noting the potential risks.

While gene therapies for treating sickle cell disease are promising, they will only be cost effective in the U.S. if priced below $2 million, according to a new modeling analysis.

Novartis spin-off Sandoz will make an upfront cash payment for the entire Cimerli ophthalmology franchise, including inventories, software and sales and reimbursement teams.

As with any new year, 2024 presents new possibilities; though new and existing challenges are also poised to shape its trajectory. BioSpace reflects on the recent JP Morgan Healthcare Conference and future outlook with key opinion leaders who share their thoughts on the economic climate.

Amid a hot antibody-drug conjugate market in oncology, Gilead Sciences announced Monday that its ADC Trodelvy did not reach a primary endpoint in a non-small cell lung cancer trial.

With initial public offering activity continuing to gain momentum in early 2024, ArriVent Biopharma in a Monday SEC filing laid out the company’s plans to go public.

The immunotherapy combination reduced the risk of disease progression or death by 79% versus chemotherapy in certain metastatic colorectal cancer patients, according to Bristol Myers Squibb.

Johnson & Johnson’s small molecule FGFR kinase inhibitor is now indicated for patients with susceptible FGFR3 mutations who progressed after at least one line of systemic therapy.

The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.

BioSpace’s Employment Outlook report investigates anticipated job search activity and hiring outlook in 2024 as well as how the current workforce is currently faring

The blank check company Thursday filed with the SEC for the initial public offering. While a specific business for Helix Acquisition Corp. II has not yet been identified, the fund will target biotech.

Amit Dagar, a former Pfizer employee, was found guilty of insider trading by a federal jury in New York involving clinical trial results for COVID-19 antiviral Paxlovid that he profited from.

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