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After back-to-back failures in 2021, Wave Life Sciences has finally aced a Phase Ib/IIa Huntington’s disease trial and is looking to a potential accelerated approval for its investigational antisense oligonucleotide.

This week, we discuss the expanded approval of Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys, Alnylam’s high stakes ATTR-CM win and highlights from ADA.

As congressional pressure increases on WuXi AppTec and other China-based companies over alleged ties to the Chinese government, India’s contract development and manufacturing organization sector could benefit.

When moving to a new role at the same company, it’s important to create a transition plan, understand your responsibilities and expectations and get to know your new team.

After winning expanded approval for its gene therapy for Duchenne muscular dystrophy, Sarepta’s leadership and analysts see a sizeable commercial opportunity on the horizon.

It’s important to maintain anonymity when seeking your next executive role, as your departure could impact other employees and the organization.

Following success in several indications including ulcerative colitis, J&J’s blockbuster drug Tremfya failed to meet a mid-stage study’s primary endpoint in treating giant cell arteritis.

Citing issues with a third-party manufacturer, the FDA has issued another Complete Response Letter to AbbVie rejecting its New Drug Application for ABBV-951, a proposed treatment for motor fluctuations in adults with advanced Parkinson’s disease.

AstraZeneca’s PD-L1 inhibitor failed to significantly improve disease-free survival in patients with non-small cell lung cancer, but hit its primary endpoint in a late-stage trial in muscle-invasive bladder cancer.

If approved, ensifentrine would be the first non-steroidal, anti-inflammatory drug for patients with chronic obstructive pulmonary disease, offering an option with potentially fewer side effects.

After being spun off of sequencing giant Illumina, Grail on Tuesday is set to start trading on the Nasdaq Global Select Market following a years-long antitrust battle with regulators.

Merck KGaA’s drug candidate xevinapant in a late-stage trial was unable to significantly improve event-free survival in patients with locally advanced head and neck cancer.

66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046) FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 Meeting Company responds to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation (BTD) and Biologics Licensing Application via Accelerated Approval Program Company’s NYSE American listing included in the Russell Microcap, Russell Microcap Value and Russell Microcap Growth indexes

MHRA seeks to harmonize UK & US regulatory review via Project Orbis EMA Rapporteur Scientific Advice Meeting scheduled for October 2025

Investment accelerates Maxwell’s path toward FDA trials and global market readiness