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Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.

Wednesday, the FDA’s VRBPAC agreed that GSK’s respiratory syncytial virus vaccine candidate is safe and effective in older adults.

As the macro pressures of higher rates and fear of recession build, today’s investor is increasingly risk averse. With zero-risk options offering decent returns, only the highest-quality programs will get funding.

The FDA greenlit Reata Pharmaceuticals’ omaveloxolone (Skyclarys) as the first and only treatment for Friedreich’s ataxia, a rare, life-limiting neuromuscular disorder.

Find out what it takes to become a successful pharma sales rep and discover helpful career advancement tips for pharmaceutical sales representatives.

On Rare Disease Day, Feburary 28, AstraZeneca announced the creation of the Alexion, AstraZeneca Rare Disease Development Hub in Toronto, Ontario.

A variation of rage quitting, rage applying is a method of job searching that occurs when someone applies for many new roles while still employed in their current position.

Aptinyx’s NYX-458 fell short of the primary endpoint in a Phase II trial of patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies.

Theravance Biopharma is discontinuing research activities for its JAK inhibitor program in lung inflammation and reducing its headcount by about 17%.

Researchers at Kyverna Therapeutics and Cabaletta Bio hope to repurpose CAR-T cell therapy for patients with autoimmune diseases.

Billy Dunn, director of the FDA’s Office of Neuroscience, is stepping down from his post to “explore other opportunities,” according to an internal FDA e-mail.

In its 2022 financial report Monday, uniQure provided updates on the progress of its Huntington’s disease and ALS programs.

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