The EMA's CHMP said the single pivotal US trial could serve as the basis for a marketing authorization application in the EU.

Ocugen (OCGN) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, reviewed the ...

Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the ...

Access Conditionalities And Shortage Measures – A Comparison Of Commission/Parliament/Council Positions. Legal News and ...

The U.S. Food and Drug Administration (FDA) on Tuesday approved Insmed Incorporated’s (NASDAQ:INSM) Brinsupri (brensocatib 10 mg and 25 mg tablets). It is an oral, once-daily treatment for non-cystic ...

Drugs such as Ozempic, Wegovy and Mounjaro (known as semaglutide and tirzepatide) have changed the way clinicians manage ...

Collaboration Revenue: Collaboration revenue was $1.5 million for the three months ended June 30, 2025, as compared to no collaboration revenue for the three months ended June 30, 2024. The increase ...

Ianalumab prolonged the duration of safe platelet levels during and after treatment in patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids1,2 Patients treated ...

The FDA had halted use in older adults while it investigated reports of side effects. The vaccine’s label now carries new ...

Valneva SE ( NASDAQ: VALN) said on Thursday that the FDA has lifted its pause on the use of its chikungunya vaccine, Ixchiq, ...

Key Points Non-GAAP earnings per share (EPS) of $2.25 in Q2 2025 far surpassed the analyst estimate of $0.32 and rose 923% year-over-year compared to Q2 2024 (non-GAAP adjusted diluted EPS per ADS).

The regulator is allowing the firm to submit data on 4D-150 from a single Phase III trial and draw on readouts from previously conducted studies in wet AMD.