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176
Regulatory News

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...

1182
Regulatory News

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...

1103
Regulatory News

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,...

5602
Regulatory News

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...

1874
Regulatory News

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...

1643
Regulatory News

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...

1552
Regulatory News

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...

1593
Regulatory News

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...

1186
Regulatory News

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....

1637
Regulatory News

Fresh from the FDA: First-ever non-opioid for acute pain is now O...

Suzetrigine is a crucial non-opioid alternative for managing acute pain, helping to reduce reliance on opioids while ensuring effective patient r...

2406
Regulatory News

Pioneering antidiabetic leads as first FDA-approved therapy for o...

Tirzepatide improves sleep quality, promotes weight loss, and overall health in overweight people with obstructive sleep apnea.

2893
Regulatory News

Russia’s N protein-based vaccine emerges as strong contender in g...

N protein-based COVID-19 vaccine shows 85.2% efficacy and a strong safety profile, offering a crucial alternative for patients struggling with tr...

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