Helixgate https://validator.w3.org/feed/docs/rss2.html Kura spins diabetes work into a Lilly-backed biotech startup Home TwoStep Therapeutics secures $62.5m funding to advance TS-104 Solstice Oncology secures $225m to drive porustobart’s development for cancer For PDUFA VIII, the most valuable incentive may be time August biopharma layoffs impact just over 500, down 90% year over year The supply chain fault lines of modern pharma Tyra shares slip as bladder cancer responses fall short of investor expectations Drugmakers cherry pick launch regions as MFN creates ‘policy environment like an earthquake’ Encoded raises $275M series F for Dravet syndrome gene therapy Biohaven takes another hit as FDA pauses enrollment in pivotal trials for embattled epilepsy drug Novartis’ board faces investor scrutiny after M&A misfires and R&D flops Mikhail, Davis embody the FDA’s stabilization, Seehafer signals AI revolution is coming StemRIM and Shionogi Announce Topline Results of Clinical Trials of Redasemtide in Patients with Dystrophic Epidermolysis Bullosa and Acute Ischemic Stroke Precision Medicine Has a Commercialization Problem FDA clears Bayer’s Hyrnuo in first-line lung cancer, amping up Hernexeos rivalry Samsung Bio, waiting to break into peptides, nets $262M manufacturing deal with unnamed EU pharma Swiss CDMOS making moves: Lonza bets on new US facility, CordenPharma scales injectables with €80M AbbVie lines up Qulipta expansion with phase 3 win in untapped menstrual migraine indication Novartis shareholder calls for board overhaul following costly deal setbacks: Reuters mRNA cancer vaccines’ biggest barriers to market Top 10 Contract Development and Manufacturing Organizations 2026 10 CDMO Up & Comers 2026 Revvity Signs Agreement to Acquire Human Cell Design Data Integrity as the Foundation for AI Smarter Cell Culture Starts with Better Media CAR T Manufacturing in Japan Gets Boost from Teijin-Shinshu University Research Collaboration Chronic Interferon Exposure Linked to Immunosuppression in Cancer Manus and UT Austin Advance Biomanufacturing Product Recovery Through BioMADE Program NICE says no to Gilead’s lenacapavir for HIV PrEP Reviews underway of first drug for rare disease MOGAD Bayer moves Hyrnuo into frontline lung cancer treatment Could UK clinical trial revamp unlock closer ties with Canada? U.S. FDA Grants Accelerated Approval to Bayer’s Hyrnuo (sevabertinib) as a First-Line Targeted Therapy for Patients with HER2-Mutated Non-Small Cell Lung Cancer M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals Questions and Answers: FDA’s regulatory actions on over-the-counter sunscreen Jobs in Oncology/Hematology Drug Compliance Programs FDA Rare Disease Innovation Hub Should You Put Sunscreen on Infants? Not Usually Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses Why Some Treated Sleep Apnea Patients Still Battle Daytime Sleepiness MRI-Negative Temporal Lobe Epilepsy Reveals Distinct Patient Phenotypes Genomic diversity and antibiotic resistance in porcine F18 E. coli strains Rare Diseases at FDA Drugs@FDA Data Files FDA gains ‘continuity’ as Mikhail, Davis named permanent CBER, CDER leaders STAT+: Roivant is one of the savviest dealmakers in biotech. It also has a secret weapon STAT+: FDA expands Bayer lung cancer drug approval STAT+: What to expect from UniQure’s upcoming Huntington’s gene therapy readout