https://www.biospace.com/all-news All News en-US Mon, 20 Apr 2026 12:24:00 GMT https://www.biospace.com/fda/fda-policy-tracker-2026-priority-vouchers-questioned-prvs-return BioSpace Editorial Staff A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency. Mon, 20 Apr 2026 12:24:00 GMT https://www.biospace.com/fda/fda-policy-tracker-2026-priority-vouchers-questioned-prvs-return https://www.biospace.com/business/ipo-tracker-2026 Tristan Manalac Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year. Mon, 20 Apr 2026 12:11:00 GMT https://www.biospace.com/business/ipo-tracker-2026 https://www.biospace.com/biospace-layoff-tracker BioSpace Editorial Staff Follow along as BioSpace tracks job cuts and restructuring initiatives. Mon, 20 Apr 2026 12:10:00 GMT https://www.biospace.com/biospace-layoff-tracker https://www.biospace.com/drug-development/mercks-early-pd-1-vegf-data-competitive-in-lung-cancer-but-summit-looms-large Tristan Manalac While Merck’s PD-1/VEGF asset appears to match the performance of Summit Therapeutics’ ivonescimab, the pharma’s Phase 1/2 readout in non-small cell lung cancer still leaves analysts with some questions moving into later-stage development. Mon, 20 Apr 2026 11:39:38 GMT https://www.biospace.com/drug-development/mercks-early-pd-1-vegf-data-competitive-in-lung-cancer-but-summit-looms-large https://www.biospace.com/deals/ucb-elevates-epilepsy-expertise-with-up-to-1-15b-neurona-takeover Tristan Manalac The acquisition of Neurona will put UCB in both the epilepsy and cell therapy space, even as many of its fellow pharmas move away from the latter modality. Mon, 20 Apr 2026 11:38:58 GMT https://www.biospace.com/deals/ucb-elevates-epilepsy-expertise-with-up-to-1-15b-neurona-takeover https://www.biospace.com/policy/trump-throws-support-behind-psychedelics-with-executive-order Tristan Manalac A new executive order could usher in psychedelics as the “key next wave” of mental health therapies, according to analysts at RBC Capital Markets. Mon, 20 Apr 2026 11:31:03 GMT https://www.biospace.com/policy/trump-throws-support-behind-psychedelics-with-executive-order https://www.biospace.com/from-product-to-patient-in-nuclear-medicine-why-vertical-integration-is-essential-for-a-competitive-advantage Renaud Dehareng, CEO, Curium In nuclear medicine, innovation alone isn’t enough. What matters is whether it can be delivered on time, every time, because timing is critical for our patients. And that delivery promise must hold up under real-world pressure – from routine variability to sudden disruptions that can reroute global logistics overnight. Mon, 20 Apr 2026 05:01:00 GMT https://www.biospace.com/from-product-to-patient-in-nuclear-medicine-why-vertical-integration-is-essential-for-a-competitive-advantage https://www.biospace.com/business/lillys-foundayo-reaches-1-390-patients-in-first-week-trailing-novos-oral-wegovy-launch Tristan Manalac While Novo Nordisk’s Wegovy pill reached more than 3,000 patients in its first week on the market, analysts at RBC Capital Markets said a direct comparison of the two figures could be misleading given the shorter data collection time for Foundayo. Fri, 17 Apr 2026 13:35:58 GMT https://www.biospace.com/business/lillys-foundayo-reaches-1-390-patients-in-first-week-trailing-novos-oral-wegovy-launch https://www.biospace.com/business/kailera-eyes-record-533m-ipo-to-play-in-competitive-obesity-space-with-chinese-drugs Tristan Manalac Annalee Armstrong Obesity-focused Kailera Therapeutics debuted on the Nasdaq Friday after raising a record $625 million, beating Moderna’s $600 million from 2018. Fri, 17 Apr 2026 13:00:00 GMT https://www.biospace.com/business/kailera-eyes-record-533m-ipo-to-play-in-competitive-obesity-space-with-chinese-drugs https://www.biospace.com/policy/rfk-jr-defends-makary-claims-pharma-owns-congress-and-media Tristan Manalac The pharma industry “own Congress, they own the media,” Health Secretary Robert F. Kennedy, Jr. told lawmakers by way of explaining the bad press against FDA Commissioner Marty Makary following the second rejection of Replimune’s advanced melanoma drug. Fri, 17 Apr 2026 12:37:51 GMT https://www.biospace.com/policy/rfk-jr-defends-makary-claims-pharma-owns-congress-and-media https://www.biospace.com/drug-development/novo-may-have-muscle-advantage-over-lilly-in-weight-loss-race-preprint Tristan Manalac More patients on Eli Lilly’s tirzepatide lost over 5% of their lean mass versus those on Novo Nordisk’s semaglutide, according to a study that has yet to be peer reviewed. Fri, 17 Apr 2026 12:13:30 GMT https://www.biospace.com/drug-development/novo-may-have-muscle-advantage-over-lilly-in-weight-loss-race-preprint https://www.biospace.com/fda/replimune-cries-foul-on-regulatory-flexibility-but-many-americans-want-a-stricter-fda Heather McKenzie After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems. Fri, 17 Apr 2026 11:48:34 GMT https://www.biospace.com/fda/replimune-cries-foul-on-regulatory-flexibility-but-many-americans-want-a-stricter-fda https://www.biospace.com/drug-development/mercks-pd-1-vegf-data-star-in-stacked-lineup-of-aacr-26-data-reveals Nick Paul Taylor The Merck update, which will shed light on a $588 million bet to succeed Keytruda, is part of a roster of presentations that could shape the future of ADCs, protein degraders and KRAS-targeted therapies. Fri, 17 Apr 2026 04:03:00 GMT https://www.biospace.com/drug-development/mercks-pd-1-vegf-data-star-in-stacked-lineup-of-aacr-26-data-reveals https://www.biospace.com/drug-delivery/funding-the-future-of-european-biotech Jennifer C. Smith-Parker BioSpace Insights In this episode of Denatured, you'll be hearing from Edoardo Negroni, co-founder & managing partner at AurorA-TT and Naveed Siddiqi, senior partner, Venture Investments at Novo Holdings. We debate whether Europe’s world-class science can be matched by a truly integrated venture ecosystem—and what it would take, in practice, to get there. Thu, 16 Apr 2026 22:05:45 GMT https://www.biospace.com/drug-delivery/funding-the-future-of-european-biotech https://www.biospace.com/policy/trump-nominates-new-cdc-director-appoints-various-leaders-to-embattled-agency Heather McKenzie Erica Schwartz, a former deputy surgeon general and member of the U.S. military, will take over from what has amounted to a rapid succession of CDC leaders over the past year. Thu, 16 Apr 2026 22:05:22 GMT https://www.biospace.com/policy/trump-nominates-new-cdc-director-appoints-various-leaders-to-embattled-agency https://www.biospace.com/fda/drug-pricing-watchdog-calls-for-increased-transparency-into-fdas-accelerated-approval-decisions Heather McKenzie Greater transparency in FDA decision-making was possibly the most common theme for stakeholders interviewed by the Institute for Clinical and Economic Review in a new report focused on strengthening the agency’s accelerated approval program. Thu, 16 Apr 2026 16:27:27 GMT https://www.biospace.com/fda/drug-pricing-watchdog-calls-for-increased-transparency-into-fdas-accelerated-approval-decisions https://www.biospace.com/fda/fda-mulls-compounding-for-peptides-previously-flagged-over-safety-risks Nick Paul Taylor With Health Secretary Robert F. Kennedy Jr. declaring himself “a big fan of peptides,” the FDA has arranged an advisory committee to discuss allowing compounders to make molecules despite earlier safety concerns. Thu, 16 Apr 2026 16:03:50 GMT https://www.biospace.com/fda/fda-mulls-compounding-for-peptides-previously-flagged-over-safety-risks https://www.biospace.com/drug-development/meiragtx-spying-hope-in-a-failed-trial-buys-back-eye-disease-gene-therapy-from-j-j Annalee Armstrong J&J will hand over the rights to bota-vec for $25 million upfront, clearing MeiraGTx to seek regulatory approvals in the U.S. and EU in 2027. Thu, 16 Apr 2026 14:27:56 GMT https://www.biospace.com/drug-development/meiragtx-spying-hope-in-a-failed-trial-buys-back-eye-disease-gene-therapy-from-j-j https://www.biospace.com/business/lillys-foundayo-posts-outstanding-diabetes-data-possibly-easing-fda-safety-concerns Gabrielle Masson Right after the FDA flagged safety concerns for Eli Lilly’s newly approved obesity pill, the pharma posted diabetes data demonstrating a clean safety profile and revealed plans to seek approval in the indication. Thu, 16 Apr 2026 13:48:59 GMT https://www.biospace.com/business/lillys-foundayo-posts-outstanding-diabetes-data-possibly-easing-fda-safety-concerns https://www.biospace.com/drug-development/can-europe-turn-world-class-science-into-world-class-scale Jennifer C. Smith-Parker BioSpace Insights Despite exceptional regional hubs and research strength, investors say Europe still needs more integrated incubators, smarter regulation and broader pools of patient capital to keep breakthrough companies growing at home. Thu, 16 Apr 2026 13:48:22 GMT https://www.biospace.com/drug-development/can-europe-turn-world-class-science-into-world-class-scale