BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at Venclexta

Ayisha Sharma / endpoints - BeOne Medicines has clinched US accelerated approval for its drug sonrotoclax in a rare but aggressive form of blood cancer, where AbbVie and Genentech’s Venclexta is used off-label. The FDA greenlit ...

AI Summary: BeOne Medicines secured FDA approval for a next-generation BCL2 inhibitor, positioning the drug as a direct challenge to AbbVie/Roche’s Venclexta franchise. The move reshuffles competitive dynamics in hematology, potentially offering clinicians an alternative and setting the stage for market share battles and payer negotiations. Expect aggressive positioning and head-to-head data requests.

Favipiravir for Lassa fever: an open-label, randomized controlled phase 2 trial

Cyril Erameh / nature - Nature Medicine, Published online: 15 May 2026; doi:10.1038/s41591-026-04402-wAn open-label, randomized controlled phase 2 trial comparing favipiravir with ribavirin for the treatment of mild-to-moderate Lassa fever in Nigeria found that favipiravir was s…

AI Summary: An open-label, randomized Phase 2 trial of favipiravir for Lassa fever reported encouraging results, suggesting antiviral benefit where few options exist. The study offers early clinical proof-of-concept, especially important for endemic West African settings, and calls for larger trials to confirm efficacy, optimize dosing, and assess deployment logistics.

Bristol Myers Squibb and Hengrui Forge $15.2 Billion Strategic Alliance, Reshaping China-Out Licensing Landscape

oncodaily - Bristol Myers Squibb (NYSE: BMY) and Jiangsu Hengrui Pharma (600276.SH; 01276.HK) on Tuesday unveiled one of the largest cross-border biopharma collaborations of the year: a global strategic alliance encompassing 13 […]

AI Summary: Bristol Myers Squibb and Hengrui Pharma announced a sweeping strategic alliance covering multiple oncology assets, with potential payments and milestones that could reach roughly $15.2 billion. The deal bundles discovery, development and commercialization rights, reshaping China‑out‑licensing dynamics and signaling continued consolidation and collaboration in global cancer drug development.

A Cancer Driven by Ultra-Rare Mutation Gets Its First FDA-Approved Therapy

Frank Vinluan / medcitynews - Partner Therapeutics’ Bizengri is now FDA approved for treating advanced cases of cholangiocarcinoma driven by NRG1 gene fusions. Partner acquired U.S. rights to this bispecific antibody from Merus in 2024. The post A Cancer Driven by Ultra-Rare Mutation …

AI Summary: The FDA approved zenocutuzumab‑zbco for NRG1‑fusion–positive cholangiocarcinoma, delivering the first cleared therapy for cancers driven by this ultra‑rare genomic alteration. Trial data showed meaningful responses in heavily pretreated patients, prompting regulators to greenlight a precision option that offers targeted benefit where none existed — a small‑population win for genomic oncology.

Study reveals how parenting styles shape babies' willingness to help others

medicalxpress - New research from Durham University shows that the way parents instruct and encourage infants to help plays a key role in how helping behavior develops, and that these approaches vary across cultures.

AI Summary: The RESET‑C trial tested one preoperative dose of pembrolizumab in localized mismatch repair‑deficient colon cancer and recorded unexpectedly high tumor responses, with several patients remaining cancer‑free for nearly three years. The dramatic neoadjuvant activity suggests immune priming could reshape perioperative strategies and raises questions about surgery timing and organ preservation.

UCB bets $2 billion on Candid's T cell engager ambitions

Kyle LaHucik / endpoints - Ken Song has done it again. The biopharma veteran's all-out effort to prove T cell engagers' potential in autoimmune diseases is getting picked up by one of Europe’s oldest pharma companies. UCB is paying $2 ...

AI Summary: UCB has struck a roughly $2 billion deal to acquire Candid, betting heavily on Candid’s T‑cell engager platform to reset immune‑based oncology programs. The acquisition boosts UCB’s immuno‑oncology pipeline and signals intensified competition in T‑cell engager development, with investors and researchers watching closely to see how science translates into clinical wins.

The peptide problem: Hype is outrunning the evidence

medicalxpress - Health Canada recently warned Canadians not to buy or inject unauthorized peptide drugs sold online, naming products that include BPC-157, CJC-1295, ipamorelin, TB-500 and retatrutide.

AI Summary: The booming market for peptide therapies and supplements is racing past the science. Researchers report limited clinical evidence, unclear long-term safety, and weak regulatory oversight, while consumer demand and marketing hype surge. Clinicians urge caution: biological plausibility isn’t the same as proven benefit, and enthusiasm should not substitute for rigorous trials.

Atara, Pierre Fabre's cell therapy to get another shot at FDA approval

Max Gelman / endpoints - There's new life for a twice-rejected T cell therapy from Atara Biotherapeutics and Pierre Fabre Pharmaceuticals. US regulators are willing to reconsider using a Phase 3 study as the basis for an approval, Atara said ...

AI Summary: Regulators have agreed to re-examine a previously rejected cell‑therapy application for a rare lymphoma, giving the Atara‑Pierre Fabre program another opportunity at approval. The decision follows additional data and stakeholder engagement, offering the developer a second bite at the apple and patients a renewed, if cautious, hope for a novel treatment pathway.

Amgen files update to Tavneos label as FDA escalates push to withdraw

Nicole DeFeudis / endpoints - Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA. The company filed a supplement on Wednesday that would add more information to the warning ...

AI Summary: Regulators have intensified scrutiny of Amgen’s Tavneos, weighing withdrawal amid safety and efficacy concerns. Amgen responded by filing a label update as the agency evaluates next steps, setting up a regulatory standoff that could alter patient access and the drug’s commercial fate while investigators review supporting trial data.

Chiesi signs $1.9B deal to acquire KalVista and its approved drug

Kyle LaHucik / endpoints - Chiesi is buying commercial biotech KalVista Pharmaceuticals for about $1.9 billion in an extension of the industry's vigorous spring shopping spree. The Italian pharma will pay $27 per share {$KALV} in cash to buy the ...

AI Summary: Chiesi Group agreed to buy KalVista for $1.9 billion to secure an approved therapy and expand its rare-disease footprint. The deal transfers marketed assets and R&D capacity, positioning Chiesi to scale rare-disease revenues and invest in next-wave therapeutics — essentially a big check for a bigger strategic play.

Avalyn Pharma Takes a Breath to Raise $300M in IPO Cash for Lung Drug Trials

Frank Vinluan / medcitynews - Avalayn Pharma found strong investor interest in its inhalable drugs in development for two types of pulmonary fibrosis, enabling the company to upsize its IPO. Data from two mid-stage studies are expected in 2027. The post Avalyn Pharma Takes a Breath to…

AI Summary: Avalyn Pharma has substantially increased its IPO, targeting roughly $300 million to bankroll late-stage trials of its respiratory drug candidate. The move reflects strong investor enthusiasm for lung‑disease therapeutics and gives the company a bigger war chest to advance programs previously dependent on venture capital and partnerships.

Preclinical evaluation of antisense oligonucleotide therapy in a mouse model of HNRNPH2-related neurodevelopmental disorder

Ane Korff, Xiaojing Yang, Ozan Ozdemir, Ananya Samanta, Yong-Dong Wang, Tushar Patni, Alfonso J. Lav / science - Science Translational Medicine, Volume 18, Issue 846, April 2026.

AI Summary: Researchers report that antisense oligonucleotide therapy reversed neurological deficits in mouse models of HNRNPH2‑related neurodevelopmental disorder. The preclinical results provide a targeted mechanism to correct pathogenic RNA processing, moving a once‑untreatable condition toward a plausible therapeutic path — pending the usual caution about translating mice to humans.

Erectile disorder: How science is moving beyond Viagra

medicalxpress - Erectile disorder (ED) refers to a persistent difficulty achieving or maintaining an erection sufficient for satisfying sexual activity. It affects millions of men worldwide, including up to 1 in 4 in the United States. Beyond physical functioning, erecti…

AI Summary: Researchers are advancing alternatives to sildenafil-era approaches for erectile disorder, exploring new biological targets and therapies that aim to restore function rather than just patch symptoms. The coverage explains emerging mechanisms, investigational treatments and the shifting clinical landscape—because sometimes a Band-Aid on performance isn’t the long-term plan.

WHO approves first malaria treatment for infants

medicalxpress - The World Health Organization announced Friday that it had given prequalification approval to a malaria treatment for newborns and infants for the first time.

AI Summary: The World Health Organization has cleared the first malaria treatment specifically for infants, granting prequalification that paves the way for broader procurement and use in endemic countries. Regulators' sign-off targets a vulnerable age group long underserved by effective pediatric therapies, potentially speeding distribution through global health channels and donor programs.