Novo Nordisk Ziltivekimab Fails Late-Stage Cardiovascular Trial, Shares Fall 10%
Novo Nordisk's Phase 3 trial of ziltivekimab, a drug being studied for cardiovascular risk reduction, did not meet its primary endpoint, sending shares lower an
ET Pharma · +14 outlets
FDA Panel Votes Supportively on Replimune Melanoma Drug but Documents Hint at Rejection Risk
Replimune shares swung sharply as an FDA panel gave a supportive vote on its melanoma therapy IGNYTE data, but FDA staff documents raised concerns about approva
simplywall.st · +2 outlets
Capricor Plunges After FDA Panel and Staff Question Deramiocel Effectiveness
Capricor Therapeutics shares collapsed after an FDA advisory committee and agency staff raised doubts about the efficacy of its lead candidate deramiocel, trigg
Genetic Engineering and Biotechnology Ne · +8 outlets
Apnimed Raises $192M in IPO for First Oral Sleep Apnea Drug
Apnimed went public with a $192 million IPO to advance what could become the first oral treatment for obstructive sleep apnea, a condition currently dominated b
MedCity News · +3 outlets
GLP-1 Drugs Wegovy and Mounjaro Flagged for Abuse in South Korea as Sales Surge
South Korean regulators are moving to flag Novo Nordisk's Wegovy and Eli Lilly's Mounjaro for potential abuse as demand for weight-loss drugs drives a sharp inc
KED Global · +2 outlets
AstraZeneca Reportedly Targets $400B Merger with Bristol Myers Squibb
A report claims AstraZeneca is pursuing a $400 billion merger with Bristol Myers Squibb, twelve years after it rejected a takeover approach from Pfizer, which w
Tech Times · +1 outlets
Intellia Shares Surge 35% Ahead of First Phase 3 Readout for Gene-Editing Therapy
Intellia Therapeutics stock jumped overnight as retail sentiment peaked ahead of the first-ever Phase 3 data readout for a CRISPR-based gene-editing therapy.
Stocktwits
Viking Therapeutics CEO Says Obesity Drug Can Offer What Rivals Cannot
Viking Therapeutics CEO argued its investigational obesity drug offers a differentiated profile versus GLP-1 competitors, though VKTX stock lagged GLP-1 peers i
Stocktwits · +9 outlets
FDA Approves AbbVie Drug for Rare Blood Cancer
AbbVie won FDA approval for a new treatment targeting a rare hematologic cancer, boosting ABBV shares.
Stocktwits · +14 outlets
SK Pharmteco Completes Obesity-Drug API Plant, Setting Up Peptide CDMO Rivalry with Samsung
SK Pharmteco finished construction of a plant for obesity-drug active pharmaceutical ingredients, positioning itself to compete with Samsung in the peptide cont
Seoul Economic Daily
FDA Approves Palbociclib for HR+, HER2+ Breast Cancer Maintenance Therapy
The FDA approved Pfizer's palbociclib for maintenance treatment of HR-positive, HER2-positive breast cancer, expanding the label for the CDK4/6 inhibitor.
The American Journal of Managed Care · +14 outlets
Sellas Life Sciences Stock Hits 3-Year High as AML Drug Trial Nears Final Readout
Sellas Life Sciences shares reached a multi-year high as its Phase 3 trial for an acute myeloid leukemia drug approaches final data, with analysts projecting fu
Stocktwits · +6 outlets
Senate Panel to Examine Biotech's Role in U.S. Health Resilience
A U.S. Senate committee will hold hearings on how the biotechnology sector can strengthen national health security and supply chain resilience.
Legis1
VA Launches Nationwide Trial of GLP-1 Drugs as Alcohol Addiction Treatment for Veterans
The Department of Veterans Affairs began a nationwide clinical trial testing GLP-1 medications as a treatment for alcohol use disorder in veterans.
International Business Times Australia · +13 outlets
South Korea Generic Drug Price Cuts Stir Industry Demand for Predictable Safeguards
South Korean drug price reduction policies are causing strain among pharmacies and prompting the pharmaceutical industry to call for more predictable, innovatio
Chosunbiz
FDA Fast-Tracks Psychedelic Research After Trump Executive Order, CMPS and HELP Stocks Gain
The FDA granted fast-track designation to psychedelic therapy programs following an executive order from President Trump, lifting shares of companies like Compa
Stocktwits · +14 outlets
103 Pharma Firms Hit with NPPA Notices Over Alleged Medicine Overcharging in India
India's drug price regulator sent demand notices to 103 pharmaceutical companies alleging overcharging on medicines, intensifying pricing scrutiny in the Indian
Medical Dialogues · +1 outlets
FDA Approves Afrezza Inhaled Insulin for Children with Diabetes, MannKind Stock Jumps
The FDA expanded approval of MannKind's Afrezza inhaled insulin to include pediatric patients, sending MNKD shares higher.
Stocktwits · +5 outlets