News

WuXi Biologics Ireland Facility Receives EMA Approval for Commercial Manufacturing of Innovative Biologic

WuXi Biologics (Stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today ...
TipRanks on MSN7h

Ascentage Pharma receives clearance from U.S. FDA, EMA to conduct GLORA-4

Ascentage Pharma (AAPG) announced that it has received clearance by the U.S. Food and Drug Administration, FDA, and the European Medicines Agency, ...
Newspoint on MSN3d

If you take injections for weight loss, you may lose your eyesight; Scientists issued a warning.

Nowadays in this fast paced life, people are not able to pay much attention to themselves, due to which body weight starts increasing, and the belly bulges out. To avoid this, people are using ...
BMJ Open4d

The OPTION trial: outpatient induction of labour – study protocol for a prospective, non-inferiority, multicentre randomised controlled trial

Introduction Sweden, as many other high-income countries, has adopted guidelines to offer induction of labour at 41+0 gestational weeks to decrease the risk for perinatal death. As more than 20% of ...
Precision Medicine Online4d

Ocugen Gets EMA Feedback on Path to Approval for Stargardt Disease Gene Therapy

The EMA's CHMP said the single pivotal US trial could serve as the basis for a marketing authorization application in the EU.
The Bakersfield Californian4d

Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to ...

Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the ...
Conventus Law4d

The New EU “Pharma Package”: Access Conditionalities And Shortage Measures – A Comparison Of Commission/Parliament/Council Positions.

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

FDA Approves Insmed's Drug As First Treatment For Type Of Chronic Lung Disease

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 ...
TMCnet5d

Korro Reports Second Quarter 2025 Financial Results and Provides Business Updates

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 ...
Novartis6d

Novartis ianalumab Phase III trial meets primary endpoint in ITP, demonstrating statistically significant improvement in time to treatment failure

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 Joplin Globe6d

KalVista Pharmaceuticals Announces Maintenance of Orphan Designation for Sebetralstat in European Union

KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) confirmed maintenance of orphan designation ...
The Bakersfield Californian9d

Sarepta Therapeutics (SRPT) Declines Again On EMA Recommendation to Refuse ELEVIDYS Marketing ...

On July 24, 2025, the European Medicines Agency (“EMA”) recommended the refusal of the marketing authorization for ELEVIDYS, Sarepta’s medication intended for ...