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The transaction, Ginkgo’s largest acquisition to date, is expected to close by the first quarter of 2023, subject to regulatory approval and other closing conditions.

The complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve Lumryz.

Daiichi-Sankyo and AstraZeneca’s sBLA for HER2 directed Enhertu accepted by FDA. Novartis gets BLA acceptance for MS biosimilar. HOOKIPA’s IND for prostate cancer immunotherapy candidate accepted

A study published this month in Science discusses data that may support a devious alter ego of T-cells present within colorectal cancers that appear to inhibit and promote tumor progression.

The announcement signals that the WHO now views the outbreak as significant enough that a coordinated global response is necessary to control it.

Replay features next-generation genomic medicine technologies in its portfolio to address the needs of diseases that have large unmet needs.

In 2000, China did not have one company on the Forbes Global 2000 list. In 2021, it had 14. This is good for second place on this list, behind the United States which had 31.

FDA Weekly Review looks at the FDA’s actions related to drug approvals, IND approvals, designations and more. Here’s a look at what happened this week.

VistaGenTherapeutics announced data showing that its nasal spray candidate for anxiety, depression and other central nervous system disorders, fell short of its primary endpoint.

“The applications for mRNA are quite broad, because, basically, you are giving information to a cell to make any protein you want,” CureVac CFO Pierre Kemula told BioSpace.

Maxvax and Luzhu are raising funds to move their respective research and development programs for recombinant herpes zoster vaccine candidates and new adjuvant products.

Researchers evaluate just how well therapeutic antibodies and antivirals work against Omicron, Vaxart’s oral vaccine shows early promise and hypertension doubles the risk of hospitalization.

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