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FDA clears first oral PCSK9 inhibitor for management of high chol...
FDA approves enlicitide as the first oral PCSK9 inhibitor, delivering a groundbreaking once-daily pill option to slash "bad" cholestero...
Tapinarof 1% cream gains strong guideline support for children wi...
The 2026 AAD guidelines strongly recommend tapinarof 1% cream for children aged ≥2 years with atopic dermatitis. It is the only steroid-free t...
Etripamil nasal spray receives FDA approval for rapid relief of P...
FDA has approved intranasal etripamil for paroxysmal supraventricular tachycardia, delivering fast, on-demand restoration of normal heart rhythm....
FDA clears new oral therapy rilzabrutinib for treatment-resistant...
FDA approves rilzabrutinib tablets as a new oral treatment option for adults with persistent or chronic ITP who show insufficient response to sta...
FDA expands access to omalizumab therapy with first interchangeab...
The FDA has authorized omalizumab-igec as the first interchangeable biosimilar to omalizumab for treating asthma, urticaria, chronic rhinosinusit...
FDA introduces front-of-package nutrition labels to tackle chroni...
The FDA has proposed requisition of front-of-package nutrition labels on most packaged foods to clearly display levels of saturated fat, sodium,...
EMA issues flu vaccine composition guidance for 2025/2026 season
EMA recommends updated trivalent influenza vaccines for the 2025/2026 season, selecting strains based on global surveillance data and excluding B...
Reddy’s and Henlius collaborate to commercialize daratumumab bios...
Dr. Reddy’s has secured exclusive U.S. and Europe commercialization rights for Henlius’s daratumumab biosimilar HLX15 in a deal worth...
Dr. Reddy’s and Bio-Thera forge strategic alliance to expand bios...
Dr. Reddy’s and Bio-Thera Solutions have entered into exclusive commercialization and license agreements for two proposed biosimilars&mdash...
Sanofi and Dr. Reddy’s partner to introduce RSV protection for pe...
Dr. Reddy’s Laboratories has entered into an exclusive agreement with Sanofi to promote and distribute nirsevimab in India—a single-d...
New FDA-approved medication for hemophilia offers dosing every 2...
Fitusiran, a groundbreaking treatment for hemophilia A and B is approved by the FDA, offering a less frequent dosing schedule of once every 2 mon...
FDA greenlights dupilumab for adolescents and adults with chronic...
Dupilumab has received FDA approval for chronic spontaneous urticaria in patients aged 12 years and older, expanding its use to over 300,000 U.S....
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