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Pharma News
Pharma News
Relay Thera’s Zovegalisib Wins FDA Breakthrough Status for Breast Cancer
Relay Thera’s zovegalisib wins FDA Breakthrough Therapy designation for PIK3CA mutant, HR+/HER2- breast cancer with fulvestrant.
Limitations of MASH Preclinical Studies Challenge Drug Development
Experts argue reducing liver fat is not enough for MASH drugs. Preclinical approaches must verify hepatocellular carcinoma suppression and long-term data.
FDA’s New PreCheck Scheme to Boost US Manufacturing Commences Applications
FDA starts accepting PreCheck applications to streamline US pharmaceutical manufacturing facilities, confirmed by Marty Makary to boost security.
GSK5764227 (HS-20093): New HER2-Targeted ADC Treatment for Cancer
GSK5764227 (HS-20093) is an experimental HER2-targeted antibody-drug conjugate studied in the Phase I ARTEMIS-001 clinical trial for solid tumors.
Thousands of Cholesterol Drug Bottles Recalled Nationwide Over Defects
Zydus and AvKARE recall thousands of cholesterol drug bottles nationwide due to manufacturing defects, subpotency, and dissolution issues per FDA.
Corcept Shares Tumble After FDA Letter Reveals Warnings Before Drug Rejection
Corcept shares fell 16% after a corrected FDA letter revealed warnings against submitting relacorilant for Cushing's due to efficacy and safety issues.
Pharma M&A Set to Boom in 2026: $240 Billion Deal Value in 2025
Pharma M&A deal value rose 81% to $240 billion in 2025. Big Pharma acquisitions and China biotech innovation drive 2026 boom expectations.
FDA Accepts Otsuka’s Centanafadine Application for ADHD Treatment
FDA accepts Otsuka's NDA for centanafadine, a novel NDSRI for ADHD. Priority review granted with PDUFA date of July 24, 2026.
Biogen's Autoimmune Candidate Litifilimab Gets FDA Breakthrough Status
FDA grants Breakthrough Therapy designation to Biogen's litifilimab for cutaneous lupus erythematosus based on phase II LILAC study results.
AstraZeneca Pledges $15bn for China R&D and Manufacturing Expansion
AstraZeneca invests $15bn in China R&D and manufacturing to boost cell therapy and oncology pipeline, aligning with Healthy China 2030 strategy.
Eli Lilly Outlays $1.12bn for Hearing Loss Gene Therapy Partnership
Lilly and Seamless Therapeutics sign $1.12bn deal for recombinase-based gene therapies for hearing loss and DNA editing.
Solvonis Expands SVN-015 into Depression Following Positive Preclinical Data
Solvonis expands SVN-015 SDRI into depression after positive preclinical data showing antidepressant activity comparable to fluoxetine.
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