Machine-readable digital standards integrated into LIMS, ELNs, and regulatory platforms reduce transcription risk, streamline ...
The FDA has approved AbbVie's JUVMO (tavapadon), as the first and only selective D1/D5 receptor agonist for adults with ...
In a preview of their panel discussion at AAPS PharmSci 360 2026, Alfred Rumondor, PhD, AbbVie, and Swita Singh, PhD, Bristol ...
Richard Jaenisch weighs how FDA's new NAM rule could reshape preclinical testing and what CMC teams should do now, on Manufacturing Intelligence. The FDA's September 22 direct final rule, which swaps ...
Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy. In part 2, of a 3-part interview, Ronald T. Piervincenzi, ...
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions ...
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical ...
Understand why the FDA's shift toward single pivotal Phase III trials requires establishing a drug's mechanistic hypothesis ...
FDA will review discrete IND modules during pre-IND rather than waiting for a full submission, with the goal of de-risking ...
The EC has approved AstraZeneca's Trixeo Aerosphere as the first single-inhaler triple-combination therapy for asthma in the EU, based on phase e data showing improved lung function and fewer severe ...
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits ...
With the FDA’s rule in place, sponsors now have clearer regulatory footing to submit nonclinical data generated through validated alternative methods as part of IND and marketing applications, though ...
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