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Johnson & Johnson on Wednesday reported multi-billion earnings from its Kenvue consumer health spinout, with updated 2023 revenue guidance down from its previously announced range.

In this special report, BioSpace examines how the biopharma industry is grappling with impending consequences of the Inflation Reduction Act.

With new Alzheimer’s drugs receiving—and expected to receive—FDA approval, the market for diagnostic biomarker tests is set to expand.

This is the Danish company’s second obesity-focused acquisition in three weeks. Under the deal, Novo Nordisk receives the full rights to develop and commercialize Embark’s lead metabolic platform.

The current workforce lacks the skills to move these biological treatments through the regulatory and production pipeline, a new report finds.

As the new CEO of LimmaTech Biologics, Haas’ IP and legal background sets him apart to lead the charge for the team’s bacterial vaccine pipeline.

However, a lack of regulatory harmonization risks undermining the effective implementation of these technology-driven approaches.

Citing lack of evidence and manufacturing issues, the regulator has rejected Outlook Therapeutics’ bid to have its bevacizumab formulation approved for wet age-related macular degeneration.

In the latest salvo, Pfizer and BioNTech fired back at Moderna and asked the U.S. Patent and Trademark Office to invalidate patent claims over the COVID-19 vaccines they say are overly broad.

The company’s pamrevlumab has failed another late-stage study in Duchenne muscular dystrophy, unable to significantly improve functional motor abilities over placebo.

Bristol Myers Squibb announced Monday that Reblozyl is now approved as a first-line treatment for adults with anemia due to myelodysplastic syndromes who may require regular blood transfusions.

The Biden administration on Tuesday released a much-anticipated list of the first 10 medicines included in Medicare’s Drug Price Negotiation Program under the Inflation Reduction Act.

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