News

Duality Biotherapeutics: First Patient Dosed in Phase 1/2 Clinical Study of Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418
Duality Biotherapeutics' ("DualityBio", HKEX:09606) partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation ...
Capital's deadly dose of deception
Delhi has long stood as a beacon of modern healthcare. The national capital is home to gleaming hospitals, internationally ...
BioSpace3d
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
Science-Based Medicine4dOpinion
Go Ahead, Make the Case That Science, Free Speech, and the FDA Are Thriving Under Drs. Marty Makary and Vinay Prasad
Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...
The American Journal of Managed Care10h
FDA Reviewing Sotatercept-csrk Label Expansion for PAH
Sotatercept-csrk was first approved in 2024 to treat pulmonary arterial hypertension (PAH) in adults based on results seen in the phase 3 STELLAR trial.
Fierce Pharma3d
‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process
When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...
FDA publishes more than 200 rejection letters in a bid to improve transparency
The U.S. FDA publishes over 200 complete response letters to enhance transparency within the agency. Read more here.
Capricor shares drop after FDA issues complete response letter for lead DMD therapy
Capricor Therapeutics (CAPR) shares fell Friday after the company announced it received a complete response letter from the FDA for its Biologics License Application for Deramiocel.
pharmaphorum23h
Makary, Prasad set out their vision for the FDA | pharmaphorum
Top FDA officials have spelled out their strategic priorities in the coming years, including the use of AI to "increase efficiency".
False Claims Act Enforcement Under the New Administration
The False Claims Act (FCA) is here to stay. That is the collective message conveyed through a series of statements, memoranda ...
Civica Appoints Dave Sehgal as Chief Manufacturing Officer and Supply Chain Officer
Civica today announced the appointment of Dave Sehgal, Ph.D. as its new Chief Manufacturing Officer and Supply Chain Officer, ...
First Patient Dosed in Phase 1/2 Clinical Study of Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418
Duality Biotherapeutics' ("DualityBio", HKEX:09606) partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage ...