Newsletter | May 13, 2025

05.13.25 -- FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating

FEATURED EDITORIAL

FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating

Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

INDUSTRY INSIGHTS

Navigating The Challenges Of Early Drug Development

Looking to avoid unnecessary delays and costly rework? Check out this webinar that shares important considerations for embarking on a new drug development program. Watch now!

Antibodies Against Antibodies? Anti-Idiotype mAb Discovery

Explore the potential of targeting LILRB2/LILRB4 in cancer immunotherapy by delving into our findings on novel monoclonal antibodies that enhance anti-tumor immune responses.

Approaching IND: What To Consider In Early Development

When preparing for IND submission, developers must consider multiple components. Explore tips for optimizing your early development program and the benefits of housing all activities under one roof.

Improving Sustainability Via Incineration Reduction And Solvent Recovery

Wastewater incineration reduction and solvent recovery are two sustainable process techniques that can be built into the drug manufacturing workflow to significantly reduce carbon emissions and waste.

Identify And Mitigate Absorption Risks With PBPK Modeling

See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

MOST POPULAR NEWS

FDA Accepts Filing Application For Oral Semaglutide 25 mg

Accelerating Drug Discovery With A Single Carbon Atom

Iambic Announces Enchant v2, Its Next Gen AI Model For Predicting The Clinical Viability

Lantern Advances Drug Candidate LP-184 With IND Clearance For Phase 1b/2 Clinical Trial

AGC Biologics Partners With Novelty Nobility For Cell Line Development

Newly Launched DCx Biotherapeutics In-Licenses Discovery Platforms

Lundbeck Joins Forces With Danish Centre For AI Innovation

Citizen Health Partner To Support Long-Term Patient Outcomes In PKP2 Cardiomyopathy

Cadence Unveils Millennium M2000 Supercomputer With NVIDIA Blackwell Systems

Adcentrx Therapeutics Granted Fast Track Designation For ADRX-0706 Nectin-4 ADC

Formosa Pharmaceuticals & Almac Discovery Announce Licensing Agreement For ALM-401

SOLUTIONS

Solid Form Services

Cambrex Scientist Spotlight: Daniel Kirschner

Services For Advancing mRNA-LNPs From Bench To Clinic