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After a quiet start to 2024, the FDA is expected to decide on three applications over the next two weeks, including one for a nasal powder migraine treatment.

The agency nevertheless said that it could not definitively rule out a small risk of suicidal ideation associated with GLP-1 receptor agonists, and that it will continue evaluating the evidence.

Dropping the potential Cytokinetics buy runs contrary to Novartis’ recent dealmaking frenzy, which included the acquisition of Calypso and three research collaborations.

Biogen gained exclusive ex-U.S. rights to Ampyra in 2009 and is selling the drug under the brand name Fampyra in international markets.

Speaking to BioSpace in San Francisco, Elena Koundourakis, the head of the orexin franchise at Takeda Pharmaceuticals, gave a preview of what is ahead for its aims to treat narcolepsy.

A lot of attention at JPM was focused on the cancer space. Executives from Olema Oncology and Cyclacel spoke with BioSpace about their plans for 2024 and why biotech’s kickoff conference is important to them.

If it feels like there has never been a tougher time to look for work, you’re not alone—and you’re likely not wrong.

Carina Clingman answers questions about forging professional connections in-person and on LinkedIn.

Biologics have a major advantage over small molecule drugs under the Inflation Reduction Act’s provisions, according to stakeholders attending this week’s J.P. Morgan conference.

The German biotech is dropping $20 million upfront on two preclinical monoclonal antibodies for undisclosed targets developed by WuXi Biologics.

Analysts in life sciences play a crucial role in analyzing and interpreting data to support research, development and decision-making processes within the field.

Panelists at JPM’s Biotech Showcase gave positive projections as the year begins and offered advice to those in the space.

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