Latest News
& Press Releases

Last month, the FDA committed to designing a “fit-for-purpose” framework for regulating rare disease therapies based on patient need and realistically attainable evidence. With the upcoming decision for Capricor’s Duchenne muscular dystrophy cell therapy deramiocel, this paradigm faces its first key test.

Coherus is narrowing its pipeline projects while Gyre reorganizes after an acquisition, with both biotechs conducting workforce reductions.

The seven proposals in the Bio Advance plan include easing clinical trial starts, boosting manufacturing and establishing a new White House office to coordinate the government’s biotech policy.

Beam Therapeutics’ risto-cel provided at least 12 consecutive months of freedom from severe pain crises for patients with sickle cell disease in a mid-stage trial, setting the stage for an FDA application as early as this year.

Bayer’s Sunharbo has secured the first FDA approval of its class, establishing a regulatory pathway for other factor XIa inhibitors, such as Bristol Myers Squibb and Johnson and Johnson’s milvexian.

The series C raise, co-led by Johnson & Johnson’s venture capital arm, will help Delix Therapeutics push its novel psychedelic asset into mid-stage development for major depressive disorder.

Having linked its glucagon/GLP-1 candidate to a significant reduction in heavy drinking days, Altimmune is preparing to speak to the FDA in December about the design of a Phase 3 program.

The list honors 50 life sciences employers of choice. Employees at SERB Pharmaceuticals and CSL Behring share why their companies stand out.

Twelve marketed drugs, including Eli Lilly’s and Novo’s weight loss mega-blockbusters, will require a label change under the new FDA update.

The Phase 3 results help clarify the safety profile of Zealand and Boehringer Ingelheim’s survodutide, but analysts do not think the drug will find utility beyond patients with liver-related risk factors.

SIMS offers a secure, integrated environment for planning, conducting and reporting nonclinical safety studies — with live visibility from protocol through data collection to study report and SEND

A step toward getting imaging data from trial sites to central review with less friction and the same scientific rigor.

US Based Clinical Stage Oncology Company Begins Critical Step Following Successful September 2026 Scientific Advice Meeting Submission expected to be accepted in the fourth quarter of 2026 Potential early market access decision expected from MHRA in the first quarter of 2027

Patent Grant in the U.S. marks a major milestone in global IP strategy, advancing protection of its VIVI Cap Smart(TM) platform Highlights U.S. patent officially granted by the U.S. Patent Office on September 29, 2026 Covers core innovations underpinning TempraMed’s VIVI Cap Smart™, which was launched earlier this year Strengthens the Company’s global intellectual property position with 39 granted patents and registered designs across multiple jurisdictions, in addition to pending patent and design applications TempraMed portfolio now available across McKesson Medical-Surgical’s U.S. B2B network, including Optum Now, physician offices, long-term care and home health, under an expanded agreement signed in June 2026 Online B2C distribution in the U.S. through Amazon, and Walmart

Faster Expression. Deeper Validation. Integrated Support.