News

pharmaphorum2d
GSK goes for gold as FDA starts review of daprodustat
If the FDA is happy with daprodustat's safety profile and approves the drug, it will help GSK meet its target of £500 million to £1 billion ($650 million to $1.3 billion) in sales for the drug ...
pharmaphorum6d
After FDA snub, EMA backs FibroGen, Astellas' roxadustat
Akebia has filed for FDA approval of vadadustat with a decision due by 29 March next year, while GSK claimed its first approval for daprodustat under the Duvroq brand name in Japan in June.
CURE4d
Therapies Which Received FDA Approval in July: What Patients Should Know
Breaking down what patients should know about each FDA therapeutic approval from June 2025 across various oncology ...
Medscape5d
FDA Approves First Treatment for Macrophage Activation Syndrome in Still Disease
Emapalumab is approved for both adults and pediatric (newborn and older) patients with MAS in Still disease with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.
Healio5d
FDA approves first-ever drug for macrophage activation syndrome in Still’s disease
The FDA has approved Gamifant as the first-ever treatment for macrophage activation syndrome in Still’s disease for adults ...
Investopedia22d
Merck Gets FDA Approval to Expand Use of Its Top-Selling Drug, Keytruda - Investopedia
Merck has received approval from the Food and Drug Administration to expand use of its blockbuster drug, Keytruda, to treat head and neck cancers. Studies found patients taking Keytruda can reduce ...
CNN18d
FDA approves twice-a-year injection for HIV prevention - CNN
A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug Administration to be used to prevent HIV.
BioWorld2d
FDA approves Dizal’s sunvozertinib for metastatic non-small cell lung cancer
Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with ...
Managed Healthcare Executive5d
FDA Grants Accelerated Approval to Datroway for Previously Treated EGFR-Mutated Lung Cancer
Datroway (datopotamab deruxtecan) is the first TROP2-directed therapy approved for advanced lung cancer in the U.S.
Healio26d
FDA approves clesrovimab for preventing RSV in infants - Healio
The FDA approved the monoclonal antibody clesrovimab-cfor for the prevention of respiratory syncytial virus lower respiratory tract disease in newborns, Merck announced.Merck said it plans to make ...
Cure Today25d
FDA Approves Ibtrozi for ROS1+ Advanced Non-Small Cell Lung Cancer
The U.S. Food and Drug Administration had approved Ibtrozi (taletrectinib) for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The efficacy of the ...
ConsumerAffairs16d
FDA approves twice-yearly injection for HIV prevention
FDA Approves Yeztugo as First Twice-Yearly Injectable HIV Prevention Option in the U.S. Clinical Trials Show Near-Perfect Efficacy With 99.9% of Pa ...