By Editor , 21 September 2026
EU Approves NewAmsterdam-Menarini's Obicetrapib in Global First

Florence – September 21, 2026 -- The European Commission has granted marketing authorization for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg fixed-dose combination), marking the first global regulatory approval of obicetrapib for NewAmsterdam Pharma (Nasdaq: NAMS) and partner Menarini Group.

By Editor , 21 September 2026
Nabsys Pairs CRISPR/Cas9 With Electronic Genome Mapping in New Study

Providence, R.I. – September 21, 2026 -- Nabsys 2.0, LLC has published the first study combining CRISPR/Cas9 with its proprietary Electronic Genome Mapping (EGM) technology, demonstrating a method to both evaluate CRISPR/Cas9 activity and direct EGM to target specific genomic regions rather than only genome-wide analysis.

The preprint, titled 'CRISPR/Cas9 Optimization Using Electronic Genome Mapping: Potential Role for Studying Human Genetic Disease,' was led by John F. Thompson, Ph.D., Principal Application Scientist at Nabsys, and posted on bioRxiv.

By Editor , 21 September 2026

Beijing – September 21, 2026 -- T-MAXIMUM Pharmaceutical reported that two of three evaluable patients with refractory brain metastases from lung cancer achieved partial responses with roughly 80% tumor shrinkage after treatment with its allogeneic B7-H3-targeted CAR-T therapy, MT027, according to early data presented at the IASLC World Conference on Lung Cancer (WCLC 2026) in Seoul.

By Editor , 21 September 2026
Scinai Regains Nasdaq Compliance on $1.00 Minimum Bid Price Rule

Jerusalem – September 21, 2026 -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) has regained compliance with Nasdaq's $1.00 minimum bid price rule after its American Depositary Shares closed at or above that threshold for 19 consecutive business days, Nasdaq Listing Qualifications confirmed in a September 18, 2026 letter.

By Editor , 21 September 2026
FDA Grants Priority Review to Insmed's ARIKAYCE Full Approval Bid

Bridgewater, N.J. – September 21, 2026 -- The U.S. Food and Drug Administration has accepted Insmed Incorporated's supplemental New Drug Application (sNDA) for full approval of ARIKAYCE (amikacin liposome inhalation suspension) to treat Mycobacterium avium complex (MAC) lung disease, granting Priority Review with a PDUFA target action date of January 28, 2027.

By Editor , 21 September 2026
FDA Grants Platform Designation to Precigen's AdenoVerse Tech

Germantown, Md. – September 21, 2026 -- The U.S. Food and Drug Administration has granted platform technology designation to Precigen's AdenoVerse immunotherapeutic platform, the technology underlying the company's first commercial product, PAPZIMEOS, approved in August 2025 for recurrent respiratory papillomatosis (RRP) in adults.

By Editor , 21 September 2026
WuXi XDC Wins GMP Release for First Overseas Site in Singapore

Singapore – September 21, 2026 -- WuXi XDC Cayman Inc. (2268.HK) has secured GMP release for its Singapore manufacturing site at Tuas Biomedical Park, marking the bioconjugate CRDMO's first overseas facility just two and a half years after the site was announced in March 2024.

By Editor , 21 September 2026
Grünenthal Buys Bayer's Stivarga in Deal Worth Up to €375M

Aachen, Germany – September 21, 2026 -- Grünenthal has agreed to acquire Bayer AG's oncology drug Stivarga® (regorafenib) for up to €375 million, adding an oral cancer treatment sold in more than 90 markets to its portfolio.

By Editor , 21 September 2026
Cellular Intelligence Adds LeCun, Moderna's Langer to Advisory Board

Boston – September 21, 2026 -- Cellular Intelligence, a Boston-based AI company building a universal foundation model of cell signaling, has appointed Turing Award laureate Yann LeCun, Moderna co-founder Robert "Bob" Langer, BioInnovation Institute CEO Jens Nielsen and Helmholtz Munich computational health director Fabian Theis to its Scientific Advisory Board. Langer also joins the company's Board of Directors as an observer.