Mike Petroutsas, president and head of U.S. commercial at Astellas, explores the importance of insight-driven ...
A $125 million near-term package comprises $50 million upfront and a $75 million equity commitment, with total potential value up to $2.325 billion including milestones and tiered low–double-digit ...
Makary’s departure followed internal disputes over approval decisions and Covid-19 vaccine posture, catalyzing a rapid ...
Dr. Richard Graham explains how FDA’s new program allows for the usage of real-time data during clinical trials. In April, ...
Biotech’s ~10-year path from private risk to approved therapy is mismatched with trading-driven capital markets, where minor ...
Pharmaceutical Executive: How are pharma companies adjusting strategies for changing FDA dynamics? David Crean: FDA is ...
Baxfendy is indicated as add-on therapy for adults inadequately controlled on other antihypertensives, with recommended dosing of 2 mg daily and 1 mg daily for higher ...
Neoadjuvant approval uses four cycles of trastuzumab deruxtecan followed by THP, improving pCR to 67.3% versus 56.3% with ddAC→THP (absolute +11.2%; P=.003). Adjuvant approval in post-neoadjuvant ...
In today's Pharmaceutical Executive Daily, FDA approves AstraZeneca's Fasenra as a new treatment for hypereosinophilic ...
ATTAIN-Maintain found oral orforglipron preserved prior loss after injection-to-oral transition, with only 0.9 kg regain from ...
Hypereosinophilic syndrome is defined by persistent eosinophilia with eosinophil-mediated organ/tissue damage, driving ...
White House sources indicate Trump approved Makary’s removal, reflecting escalating senior leadership churn across federal health agencies. Makary’s tenure featured MAHA-aligned regulatory positions, ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results