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FDA approval for AstraZeneca oral SERD in ESR1-mutant advanced breast cancer
The FDA granted accelerated approval to AstraZeneca’s camizestrant (Etcamah) for certain patients with HR+/HER2– advanced breast cancer with ESR1 mutations after the company’s April advisory...
Roivant advances pulmonary hypertension program after Phase 2 win
Roivant reported a Phase 2 success for mosliciguat in interstitial lung disease, with the inhaled therapy meeting key endpoints that could open a path into broader lung-disease programs. In a...
GSK expands antibody conjugate portfolio through Hutchmed KRAS/EGFR asset deal
GSK took ex-China rights to Hutchmed’s HMPL-A830 in a deal worth up to $1.295 billion, plus royalties, as the UK pharma deepens its push into antibody–drug conjugate (ADC) and related conjugate...
Fortrea acquires Worldwide Clinical Trials’ early phase unit for $45M
Fortrea agreed to buy Worldwide Clinical Trials’ early phase services business in a $45 million transaction, aiming to add early clinical pharmacology and bioanalytical capacity to support sponsor...
Moonwalk pulls in $70M Series B for adipose-targeted RNAi obesity therapy
Moonwalk Biosciences secured $70 million in Series B financing to advance MW101, its adipose-targeted siRNA obesity candidate, into IND-enabling work toward first-in-human trials. The company...
FDA IDE clearance enables Ciliatech glaucoma implant feasibility study
Ciliatech SAS received a U.S. FDA investigational device exemption (IDE) for its Intercil Uveal Spacer implant, enabling a feasibility study for the company’s glaucoma approach. The implant is...
New venture funding for pediatric brain cancer CAR-T from BrainChild Bio
BrainChild Bio raised $116 million in Series A funding to advance its autologous CAR-T program for pediatric brainstem tumors, with a pivotal registrational trial already underway. The company’s...
GSK and Alteogen delivery tech deal expands subcutaneous biologics push
Alteogen and Novartis expanded their collaboration after Novartis granted exclusive rights to develop and commercialize multiple products using Alteogen’s ALT-B4 subcutaneous delivery...
ARPA-H funds RNAV8 Bio to develop programmable RNA medicines
RNAV8 Bio (Renovate Bio) was selected for funding from ARPA-H under the PROPEL program, a one-year pilot of up to $4.4 million aimed at building programmable RNA medicines with controllable...
US regulators lock in FDA leadership for drug and biologics oversight
The Trump administration moved three acting FDA center heads into permanent leadership roles, stabilizing key review functions across drugs and biologics. The FDA named Michael Davis to lead CDER,...
FDA accelerated approval returns AstraZeneca’s oral SERD to first-line use
The FDA granted accelerated approval to AstraZeneca’s oral SERD camizestrant (Etcamah/camizestrant), overturning a prior advisory committee vote that had gone against the drug for first-line...
Roivant’s mosliciguat posts Phase 2 win in interstitial lung disease
Roivant reported Phase 2 success for mosliciguat, an inhaled therapy for interstitial lung disease, meeting key endpoints in a 16-week study. The company said mosliciguat achieved a statistically...
Novartis stumbles as pelacarsen fails cardiovascular Phase 3 outcomes
Novartis’ antisense therapy pelacarsen failed to demonstrate clinical benefit in its Phase 3 cardiovascular outcomes study, according to the company’s readout. Although prior work showed...
Moonwalk wins Series B funding to take adipose-targeted RNAi obesity program to humans
Moonwalk Biosciences raised $70 million in a Series B round to advance MW-101, its adipose-targeted RNAi obesity candidate, into clinical testing. The company plans to complete IND-enabling...
BrainChild Bio lands $116M Series A to run pivotal pediatric brainstem CAR-T
BrainChild Bio raised $116 million in Series A financing to push its pediatric brainstem CAR-T program toward a pivotal registrational trial. The company’s lead asset, BCB-276, targets B7-H3 for...
FDA IDE clears Ciliatech uveal spacer implant study for glaucoma
Ciliatech received an FDA investigational device exemption (IDE) for Intercil Uveal Spacer, a glaucoma implant designed to reduce reliance on weeks of postoperative self-administered eye drops....
Fortrea buys Worldwide Clinical Trials’ early-phase unit for $45M to expand pharmacology capacity
Fortrea agreed to acquire Worldwide Clinical Trials’ early-phase services business for $45 million, adding three Texas facilities and expanding its clinical pharmacology and bioanalytical...
GSK secures ex-China rights to Hutchmed’s KRAS/EGFR dual-mode ADC payload
GSK expanded into ADCs by paying up to $1.295 billion for ex-China rights to Hutchmed’s HMPL-A830, a preclinical antibody-targeted therapy conjugate. GSK will pay $110 million upfront and add...
Clean Cells adds NGS viral safety testing and acquires bioinformatics CRO Xegen
Clean Cells launched next-generation sequencing (NGS)-based viral safety testing for viral matrices, including viral vectors and recombinant preparations, and simultaneously acquired the French...
FDA leadership and technology push
The FDA permanently installed leadership across key drug and biologics review centers, following the administration’s nominations announced earlier this year. HHS named new permanent heads for...