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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.

TOP STORIES
FDA
Amid one of the industry’s steepest patent cliffs, the regulator Thursday approved Sandoz’s Tyruko, the first biosimilar for treating relapsing multiple sclerosis in adults. Sandoz is a division of Novartis.
The world’s largest buyer of biopharma royalties is paying $300 million up front and $200 million in milestone payments for Ferring Pharmaceuticals’ FDA-approved bladder cancer drug Adstiladrin.
As the FDA’s recent rejection of Biogen and Sage’s zuranolone for major depressive disorder highlights, biopharma companies will need to tackle emerging challenges to bring more of these drugs to patients.
While some biopharma companies seek an effective and non-addictive alternative to opioids, others are looking to make opioids themselves safer.
FDA
In the next two weeks, the FDA will hand out regulatory verdicts to BMS, Outlook Therapeutics and BioLineRx.
The Danish drugmaker is leveraging Thermo Fisher Scientific as Wegovy demand surges and amid production problems with manufacturer Catalent, Reuters reported on Wednesday.
Data suggests divarasib could be more potent than already approved KRAS inhibitors from Amgen and Mirati, but the study’s authors caution against cross-trial comparisons.
The company appears to be terminating the development of two Phase I antibody-drug conjugates in cancer, ABBV-011 and the Pfizer-partnered ABBV-647.
After slimming down its infectious diseases and vaccines business, Johnson & Johnson now appears to be ending research and development at a Dutch-based unit, except for a few programs.
The consumer healthcare brand is joining the growing biosimilars market in the U.S. with its new subsidiary Cordavis, which will market a Humira biosimilar as its first product.
To successfully compete against one another and Big Pharma for top talent, biotech companies need to do a better job of selling themselves.
After identifying structural variations in the 19-gauge filter needle included in some eye injection kits, Apellis has advised doctors to only use 18-gauge kits already in circulation and that will be distributed.
UPCOMING EVENTS
PRESS RELEASES
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
MARKET RESEARCH REPORTS