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Viking Therapeutics enjoyed a nice share rally on the news that rival Pfizer is discontinuing obesity candidate danuglipron. But the biotech has a long way to go to recover after six straight months of decline.

Pfizer’s discontinuation of danuglipron brings the company down to a single molecule in its obesity pipeline.

Vanda is criticizing the FDA’s restrictions on information companies can provide regarding off-label use of approved medicines.

Future Pak—whose acquisition offer was rejected by Vanda Pharmaceuticals last summer—is offering to buy Theratechnologies for an unsolicited $255 million. The Canadian biotech is under an exclusivity agreement with another yet-to-be-disclosed potential purchaser.

Leerink analysts warned that Kennedy’s remarks to FDA staff would likely be a negative for the biotech industry.

At the GenScript Biotech Global Forum 2025, industry leaders celebrated CAR T cell therapy achievements while discussing ongoing challenges in manufacturing, distribution, treatment center capacity, and global payment structures for cell and gene therapies.

AI is enabling the development of a next generation of drugs that can more precisely target cancer cells while sparing healthy tissues.

After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with regulatory experts predicting delays in drug approvals and greater influence of political appointees.

Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for Regeneron, one with partner Sanofi.

Health and Human Services employees aren’t the only ones out of work. Thousands of private-sector biopharma professionals lost their jobs in the first quarter.

As the biopharma industry grapples with the uncertain macro environment brought on by the new administration, CEOs, regulators and many others speak out.

According to analysts at Jefferies, legislation such as the newly proposed bills that aim to streamline regulatory processes would be a positive for the biotech industry.

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