EN | UA
EN | UA

Help Support

Back

News

3182
Regulatory News

Etripamil nasal spray receives FDA approval for rapid relief of PSVT episodes

FDA has approved intranasal etripamil for paroxysmal supraventricular tachycardia, delivering fast, on-demand restoration of normal heart rhythm.

6101
Regulatory News

FDA clears new oral therapy rilzabrutinib for treatment-resistant ITP

FDA approves rilzabrutinib tablets as a new oral treatment option for adults with persistent or chronic ITP who show insufficient response to standard therapies...

4549
Regulatory News

FDA expands access to omalizumab therapy with first interchangeable biosimilar

The FDA has authorized omalizumab-igec as the first interchangeable biosimilar to omalizumab for treating asthma, urticaria, chronic rhinosinusitis with nasal p...

4443
Regulatory News

FDA introduces front-of-package nutrition labels to tackle chronic disease crisi...

The FDA has proposed requisition of front-of-package nutrition labels on most packaged foods to clearly display levels of saturated fat, sodium, and added sugar...

11600
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/Yamagata due t...

5566
Regulatory News

Reddy’s and Henlius collaborate to commercialize daratumumab biosimilar HLX15

Dr. Reddy’s has secured exclusive U.S. and Europe commercialization rights for Henlius’s daratumumab biosimilar HLX15 in a deal worth up to $131.6 m...

5107
Regulatory News

Dr. Reddy’s and Bio-Thera forge strategic alliance to expand biosimilar access

Dr. Reddy’s and Bio-Thera Solutions have entered into exclusive commercialization and license agreements for two proposed biosimilars—BAT2206 (ustek...

4883
Regulatory News

Sanofi and Dr. Reddy’s partner to introduce RSV protection for pediatrics

Dr. Reddy’s Laboratories has entered into an exclusive agreement with Sanofi to promote and distribute nirsevimab in India—a single-dose monoclonal...

5067
Regulatory News

New FDA-approved medication for hemophilia offers dosing every 2 months

Fitusiran, a groundbreaking treatment for hemophilia A and B is approved by the FDA, offering a less frequent dosing schedule of once every 2 months. This appro...

4196
Regulatory News

FDA greenlights dupilumab for adolescents and adults with chronic spontaneous ur...

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. patients follo...

4135
Regulatory News

Fresh from the FDA: First-ever non-opioid for acute pain is now OK'd!

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

6114
Regulatory News

Pioneering antidiabetic leads as first FDA-approved therapy for obesity-related...

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

Try: