Formulary decisions commonly restrict access to T2D and weight loss, creating coverage blind spots as GLP-1 trials mature across broader cardiometabolic and organ-protection indications. Utilization ...
FDA reviewers argued RECIST v1.1 response and DoR may be inflated because injected-lesion shrinkage could represent local ...
FDA approval used the 505(b)(2) pathway and Phase III Luminous results to support efficacy, safety characterization, and adhesive performance in women with BMI <30 kg/m². Contraceptive efficacy in the ...
This past May, Pharmaceutical Executive reported that CVS Health decided to return Eli Lilly’s Zepbound to its list of ...
Specialty pharma launches depend heavily on data from outside the organization. Distributors, third-party logistics providers ...
Narrow votes supported compounding of BPC-157, KPV, and TB-500 (8-6; one abstention) and MOTS-c (7-5; two abstentions), without constituting FDA approval or demonstrated clinical benefit. Regulatory ...
Earlier this year, a report from Pharmaceutical Executive detailed the ways in which China is becoming an essential R&D partner for pharma and biotech companies. According to the ...
TruTechnologies’ Dr. Richard Graham explains where he sees the actual issues that need to be addressed at FDA. FDA’s latest initiative to improve the drug approval process is Project Trialblazer. The ...
This episode of The Ron Lanton Report examines why the next phase of healthcare innovation will be constrained not by capital or technology, but by people. Framing the discussion ...
Within your prior big pharma employers, AI is now a core competitive capability as it has shortened target identification and optimized molecule design. As building world-class AI drug-discovery ...
FDA authorization covers adults and children ≥6 years (≥20 kg) for once-daily centanafadine ER, positioned as a CNS stimulant with a first-in-class NDSRI mechanism. Evidence derived from four pivotal ...
A $77/share all-cash tender offer implies ~$2.2B equity value and an ~86% premium to the post–Phase Ib vitiligo data VWAP, with no financing contingency. Closing requires majority share tender and HSR ...
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