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AstraZeneca acquires global rights to approved EGFR exon 20 inhibitor Zegfrovy, Chai Discovery strikes an undisclosed AI antibody collaboration with Novartis, and Innovent Biologics licenses its CD40L antibody IBI355 to Spero Therapeutics.

FDA has approved a subcutaneous formulation of Leqembi, giving early Alzheimer's patients the option to self-administer the anti-amyloid therapy at home via weekly autoinjector.

Nuvation Bio’s CEO David Hung discusses the how Nuvation built a relatiohsip with Daichii Sankyo.

RedSail Technologies’ vp of clinical services discusses awareness and education gaps in how patients understand GLP-1s.

In today's Pharmaceutical Executive Daily, a new industry analysis warns that direct-to-patient pharma platforms are scaling faster than the safety infrastructure needed to support them, FDA issues a complete response letter to Elevar Therapeutics over manufacturing deficiencies in its liver cancer combination therapy, and Insilico Medicine deepens its partnership with China Medical System Holdings in a new AI-powered drug discovery collaboration worth up to $177 million.

David Hung, Nuvation Bio’s CEO, explains the company’s focus on providing patients with better drugs.

Insilico Medicine has deepened its partnership with China Medical System Holdings with a second CNS-focused collaboration in three months, pairing Insilico's PandaOmics-identified mechanism with CMS's clinical and commercial infrastructure in a deal worth up to $177 million in milestones.

FDA issued a complete response letter to Elevar Therapeutics for its rivoceranib and camrelizumab combination in first-line hepatocellular carcinoma, rejecting the application over manufacturing deficiencies rather than clinical concerns.

The pharmaceutical industry has spent the last two years debating whether direct-to-patient pharma business models are real. That debate is over.

FDA has paused public release of complete response letters while reviewing a citizen petition challenging the legal basis of the practice, stalling a transparency initiative the agency launched less than a year ago.

FDA has approved Sarclisa Escena as the first anticancer treatment administered via an on-body injector, offering multiple myeloma patients and providers a subcutaneous alternative to time-intensive IV infusions across all three of isatuximab's existing indications.

AstraZeneca's Wainua failed to meet the primary endpoint of a late-stage trial in transthyretin-mediated amyloid cardiomyopathy, sending shares down nearly 10% in their largest single-day decline since late 2024.

This case could redefine the legal boundary between protecting pharmaceutical patents and allowing lower-cost generic drugs onto the market.