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The Sept. 30 deadline for Congress to reauthorize the FDA’s prescription drug user fee is looming, while advocates and detractors are debating the merits of the funding source.

With a distinct take on CRISPR, Carver Biosciences secured seed financing to support the development of RNA-targeting gene therapies aimed at RNA-based respiratory infectious diseases.

There’s a new collaboration in the Parkinson’s disease development space, Cardiff Oncology kicks off a mid-phase study in colorectal cancer and Ocugen published a new review of COVAXIN.

Two days after unveiling an executive order to boost U.S. biomanufacturing, the White House unveiled plans that include $2 billion to support the initiative.

After reporting a failed clinical trial of ELX-02 for cystic fibrosis (CF), Eloxx Pharmaceuticals plans to shift its focus and use the drug to treat Alport syndrome, a rare kidney disease.

Researchers at PrecisionLife say they have found a genetic link to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Novartis confirmed it is the subject of an investigation by the Swiss Competition Commission over possible unlawful patent use.

Pfizer is leveraging its funding and experience with vaccines, developing its meningococcal, flu, and RSV vaccines. It also announced its venture investment in Nimbus Therapeutics.

Gala Therapeutics and Galaxy Medical will be folded into Galvanize Therapeutics to continue to develop their electric pulse therapies for bronchitis, cardiac arrhythmias and solid tumors.

The Institute for Clinical and Economic Review (ICER) concluded that even at a hefty lifetime cost of $2.5 million, gene therapies for hemophilia A and B are worth it.

NSCLC At ESMO: Pollution does indeed cause lung cancer; Tecentriq shows promise in poor prognosis patients, Amgen makes progress in KRAS G12-mutated disease and an update on a Daiichi Sankyo ADC.

Biden issued an executive order to keep U.S.-based innovation ahead of advances made by counterparts in China biotechnology and biomanufacturing Monday.

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