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Latest Biotech News

FDA accelerated approval for AstraZeneca oral SERD

September 08, 2026

The FDA granted accelerated approval to AstraZeneca’s oral selective estrogen receptor degrader, camizestrant (Etcamah), for certain patients with HR+/HER2− advanced breast cancer with detected...

Roivant pulmonary hypertension readout and deal momentum

September 08, 2026

Roivant reported new mid-stage success for mosliciguat, an inhaled therapy for serious pulmonary hypertension. In a 16-week Phase 2 study, the company said the drug achieved a statistically...

Bristol Myers Phase 2 CAR-T win in multiple myeloma

September 08, 2026

Bristol Myers Squibb said a pivotal Phase 2 study of its GPRC5D-directed CAR-T cell therapy hit its primary endpoint. The company’s update extends BMS’s efforts to compete for the post-BCMA...

Inhibrx OX40 agonist data in head and neck cancer

September 08, 2026

Inhibrx reported an early clinical win for its OX40 agonist, with response signals in head and neck cancer. The company framed the strongest results in a smaller subset of patients with...

Moonwalk raises Series B to advance adipose-targeted RNAi obesity drug

September 08, 2026

Moonwalk Biosciences raised $70 million in a Series B to move its lead adipose-targeted RNAi obesity candidate, MW101, toward first-in-human studies planned for late 2027. The company said...

BrainChild Bio secures $116M for pediatric brain tumor CAR-T

September 08, 2026

BrainChild Bio raised $116 million in Series A financing to accelerate development of CAR-T therapies aimed at childhood brain cancers, starting with an investigational program for diffuse...

Fortrea buys Worldwide’s early phase clinical unit for $45M

September 08, 2026

Fortrea agreed to acquire Worldwide Clinical Trials’ early phase services unit for $45 million, adding a clinical pharmacology bed network and bioanalytical capabilities to Fortrea’s portfolio....

Roche deals for preclinical trispecific TCE asset

September 08, 2026

Roche reached a potential $1.53 billion license deal for SIM-0600, a preclinical CD79a/CD19/CD3 trispecific T-cell engager from Simcere Zaiming Pharmaceutical. The agreement reflects Roche’s...

Superluminal raises $60M for rare genetic obesity MC4R agonist

September 08, 2026

Superluminal Medicines raised an oversubscribed $60 million Series B to advance a selective, biased MC4R agonist for rare genetic and hypothalamic obesity. The company said it plans to initiate...

Roche–Simcere deal in B-cell tri-specific TCEs

September 08, 2026

Roche has signed a licensing deal for SIM-0600, a preclinical CD79a/CD19/CD3-targeting trispecific T-cell engager from Simcere Zaiming Pharmaceutical. The agreement announced the potential value...

GSK takes Hutchmed’s EGFR-targeted KRAS payload ADC

September 08, 2026

GSK moved deeper into antibody-drug conjugates by securing ex-China rights to Hutchmed’s HMPL-A830 under a deal valued at up to $1.295 billion. The preclinical asset pairs an anti-EGFR antibody...

Novartis–Alteogen SC drug delivery platform expansion

September 08, 2026

Novartis granted itself a broader pathway into subcutaneous biologic formulations via Alteogen’s ALT-B4 platform. Under option agreements announced after Korean market hours, Alteogen granted...

China approves differentiated therapies: Everest heart spray and Simcere RSV antibody

September 08, 2026

China’s National Medical Products Administration (NMPA) approved two differentiated therapies aimed at reducing acute and seasonal disease burden. Everest Medicines’ Cardamyst became a...

FDA grants AstraZeneca camizestrant approval after negative adcomm vote

September 08, 2026

The FDA approved AstraZeneca’s oral SERD camizestrant (sold as Etcamah) for a subset of patients with HR+/HER2− advanced breast cancer with ESR1 mutations detected during aromatase inhibitor and...

Novartis pelacarsen Phase 3 failure dents Lp(a) clinical outcomes push

September 08, 2026

Novartis’ antisense therapy pelacarsen failed to meet clinical endpoints in a Phase 3 outcomes study, dealing another blow to the Lp(a) lowering strategy. The Lp(a)HORIZON study did not reduce the...

Roivant mosliciguat posts Phase 2 win in pulmonary hypertension

September 08, 2026

Roivant reported that mosliciguat achieved the primary endpoint in a 16-week Phase 2 study of a pulmonary hypertension population, posting a statistically significant 56% reduction in pulmonary...

Moonwalk raises $70M to advance adipose-targeted RNAi obesity program

September 08, 2026

Moonwalk Biosciences raised $70 million in a Series B round to move its adipose-targeted RNAi obesity candidate MW101 into first-in-human studies planned for late 2027. The company said...

Clean Cells expands viral safety testing with NGS and Xegen acquisition

September 08, 2026

Clean Cells launched next-generation sequencing (NGS)-based viral safety testing for viral matrices, including viral vectors and recombinant preparations, and simultaneously acquired French...

BrainChild raises $116M for pediatric brain tumor CAR-T pivotal trial

September 08, 2026

BrainChild Bio secured $116 million in venture financing to support a pivotal development program for pediatric brain tumor CAR-T therapy. The company’s BCB-276 targets B7-H3 (CD276) for diffuse...

Regulatory approvals — oncology

September 08, 2026

The FDA approved AstraZeneca’s oral SERD camizestrant (Etcamah) for a defined subset of patients with HR+/HER2– advanced breast cancer with ESR1 mutations detected during aromatase inhibitor and...