UK becomes first European country to approve Eli Lilly's oral weight loss drug Foundayo
Britain's MHRA grants the first European approval for Lilly's once-daily oral GLP-1 pill orforglipron (Foundayo), expanding obesity treatment options beyond inj
Reuters · +14 outlets
Sionna Therapeutics stock plunges nearly 100% after cystic fibrosis drug fails key trial
Sionna's lead candidate failed a pivotal trial, wiping out nearly all of the company's market value and dealing a severe setback to CF drug development.
The Business Journals · +1 outlets
Eli Lilly soars past $1 trillion market cap as Novo Nordisk stumbles
Eli Lilly's market capitalization surpasses $1 trillion fueled by weight loss drug sales while rival Novo Nordisk faces headwinds.
Investing News Network · +14 outlets
Jazz Pharma expands in epilepsy with $820M Actio Bio acquisition
Jazz Pharmaceuticals acquires Actio Biosciences for up to $820 million to add epilepsy pipeline assets.
MedCity News · +4 outlets
Vera Therapeutics TRUTAKNA gets FDA accelerated approval for IgA nephropathy
FDA grants accelerated approval for Vera's TRUTAKNA (atacicept) to treat IgA nephropathy, a rare kidney disease.
Stock Titan · +14 outlets
UK approves its second weight-loss pill while EU access lags
The UK becomes the first European country to approve Lilly's Foundayo, while broader EU approval remains pending.
politico.eu · +14 outlets
Vaderis nets $152M series B to test AKT-targeting drug; Epicrispr adds $90M for epigenetic editing
Two biotechs complete large funding rounds: Vaderis raised $152M for an AKT inhibitor program and Epicrispr raised $90M to develop an epigenetic editing therapy
fiercebiotech.com · +1 outlets
Replimune receives FDA accelerated approval for melanoma therapy
FDA grants accelerated approval to Replimune's RP1 for advanced melanoma, offering a new oncolytic virus treatment option.
simplywall.st · +14 outlets
Bristol Myers Squibb chooses Houston for $2.3B manufacturing facility
BMS selects Houston as the site for a $2.3 billion manufacturing facility, expanding its US biologics production capacity.
Genetic Engineering and Biotechnology Ne · +14 outlets
Mineralys blood-pressure candidate gets December 22 FDA target date
Mineralys Therapeutics has a PDUFA date of Dec. 22 for its hypertension candidate lorundrostat.
Stock Titan · +3 outlets
Global drugmakers invest billions to boost US presence
Major pharmaceutical companies are making multibillion-dollar investments in US manufacturing and R&D facilities.
Reuters · +5 outlets
FDA designation puts Kyverna one-dose cell therapy in focus for progressive MS
Kyverna receives an FDA designation for KYV-101, a one-dose CAR T-cell therapy being developed for progressive multiple sclerosis.
Stock Titan
Cogent Biosciences' bezuclastinib could face FDA decisions in November, December
Cogent reports Q2 results and notes potential FDA decisions for bezuclastinib in advanced systemic mastocytosis by end of 2026.
Stock Titan · +5 outlets
Samsung Bioepis seeks Korean approval for Keytruda biosimilar SB27
Samsung Bioepis applies for Korean marketing authorization of SB27, a proposed biosimilar to Merck's Keytruda (pembrolizumab).
koreabiomed.com · +4 outlets
Gan & Lee Pharmaceuticals hits daily limit up on GLP-1 deal worth up to EUR 664M
Gan & Lee shares surge after licensing its GLP-1 candidate Bofan Glutide to a European partner in a deal valued at up to 664 million euros.
finance.biggo.com · +1 outlets
CMS and HRSA propose new 340B payment changes
Federal agencies propose new rules governing payments under the 340B drug discount program, potentially reshaping hospital drug pricing.
BioXconomy · +9 outlets
Quantum BioPharma wins FDA IND clearance for Lucid-MS Phase 2 in progressive MS
Quantum BioPharma receives FDA clearance to begin Phase 2 testing of Lucid-MS, a novel therapy for progressive multiple sclerosis.
Stock Titan · +3 outlets
Medicare GLP-1 Bridge program reshapes drug pricing landscape
Medicare's coverage bridge for GLP-1 weight loss drugs is altering pricing dynamics and access for millions of beneficiaries.
BioXconomy · +14 outlets