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FDA lifts lid on Lilly’s oral SERD combination for breast cancer
Eli Lilly’s oral selective estrogen receptor degrader (SERD) Inluriyo has won FDA approval in combination for certain patients with metastatic breast cancer as a second-line regimen. The approval...
EMA CHMP recommends multiple therapies including hemophilia A preventive and ovarian cancer
The European Medicines Agency’s CHMP has recommended approving Novo Nordisk’s hemophilia A preventive drug, alongside positive opinions for seven other medicines and 11 label expansions. The...
Ultragenyx clears a regulatory hurdle for MPS IIIA after prior FDA denial
Separate from the headline approval coverage, the approval narrative reflects the tight link between FDA scrutiny and manufacturing quality for gene therapies. The Fayuvi decision follows a prior...
Lilly’s brenipatide posts early Phase I dose-selection data for CNS and addiction-adjacent disorders
Eli Lilly presented early clinical data for brenipatide, its once-weekly GIP/GLP-1 receptor agonist candidate designed to engage central nervous system and inflammatory pathways tied to reward and...
Neuron-targeted exosomes linked to shingles chronic pain mechanism
Researchers reported evidence that exosomes carrying proteins that inhibit neuron growth may contribute to chronic pain after shingles, known as post-herpetic neuralgia. The work frames the...
CAR T safety: fatal toxicities test the autoimmune risk model
New safety-focused analysis is putting pressure on the autoimmune risk thesis for certain CAR T designs, with attention on IEC-HS risk as developers test why some events may occur. The coverage...
Bavarian Nordic names new CEO after Sanofi background leadership move
Bavarian Nordic has announced Tarja Stenvall, currently a Sanofi executive, will become President and CEO effective October 15, succeeding Paul Chaplin. Stenvall has led Sanofi’s €10 billion...
AI wet-lab push: Anthropic confirms Bay Area lab while limiting drug-discovery claims
Anthropic has confirmed it opened a wet lab in the San Francisco Bay Area, while declining to specify whether it will be used for drug discovery. In comments reported by Reuters and attributed to...
Virtual digestive health startup Ayble raises $16M for clinical expansion
Ayble Health secured $16 million in a Series A round to expand its virtual digestive health clinic model. The round was led by Neon, with participation from Unum Ventures, Upfront Ventures, M13,...
FDA approval: first disease-modifying gene therapy for Sanfilippo A
The U.S. FDA approved Ultragenyx’s rebisufligene etisparvovec (Fayuvi) as the first treatment targeting the underlying cause of Sanfilippo syndrome type A (MPS IIIA), a fatal ultra-rare...
FDA decision: Lilly’s oral SERD combo moves into second-line breast cancer
The FDA approved Eli Lilly’s oral selective estrogen receptor degrader (SERD) combination regimen, Inluriyo, for certain patients in the second-line setting for metastatic breast cancer. The...
FDA regulatory stance: agency says initial drug rejections have fallen
The FDA said it is pushing back against claims that it is increasingly rejecting new drugs after an initial review, arguing that the characterization is inaccurate. The agency’s response follows...
Clinical safety signal: Xenon pauses azetukalner depression trials
Xenon Pharmaceuticals paused enrollment in its major depressive disorder and bipolar disorder trials for azetukalner after neuropsychiatric adverse events emerged that were not seen in earlier...
Company pipeline/regulatory timing: Xenon NDA for focal onset seizures under FDA review
Alongside the depression trial pause, Xenon disclosed that it has submitted an NDA to the FDA for azetukalner in focal epileptic seizures. The filing positions the same KV7 potassium channel...
Neuroscience discovery: neuron-targeted exosomes implicated in chronic shingles pain
Research suggests post-herpetic neuralgia may be driven by neuron-targeted exosomes carrying proteins that inhibit neuron growth. The study highlights blood exosomes as a source of mechanistic...
Company leadership: Bavarian Nordic appoints Tarja Stenvall as CEO
Bavarian Nordic named Tarja Stenvall as its next President and CEO, effective Oct. 15, succeeding Paul Chaplin. Stenvall previously led Sanofi’s diabetes and cardiovascular franchise as an SVP and...
Bioprocess innovation: GBI Biomanufacturing to launch SmartScale GMP for first-in-human
GBI Biomanufacturing said it will launch its SmartScale GMP Solutions platform at BioProcess International (BPI) East 2026, aiming to speed generation of cGMP material for first-in-human studies....
Biopharma funding: Electra upsizes IPO after pricing
Electra Therapeutics priced and upsized its IPO, raising $350 million to support late-stage development of ipsoprubart, a pan-SIRP monoclonal antibody in secondary hemophagocytic...
Health policy: all states sign up for Medicaid “most favored nation” pricing model
President Donald Trump announced that all 50 states, Washington, DC, and Puerto Rico will participate in a new Medicaid drug pricing model in which manufacturers provide supplemental rebates to...
FDA gene therapy approval for Sanfilippo syndrome type A
Ultragenyx secured U.S. FDA approval for Fayuvi (rebisufligene etisparvovec), the first approved disease-modifying gene therapy for Sanfilippo syndrome type A (MPS IIIA). The therapy is delivered...