New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.

The European Medicines Agency has started a review of medicines containing finasteride and dutasteride following concerns ...

Russian attackers were behind the hack of the European Medicines Agency EMA in 2020. They had “unauthorized access to ...

The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.

Czechia proposes changes that will better define the role of patient organisations when informing patients about therapeutic procedures without violating advertising regulations.

Marketing authorization for the first EU vaccine to protect adolescents against chikungunya has been expedited for its public health interest.

Egetis Therapeutics AB (publ) ("Egetis" or the "Company") (Nasdaq Stockholm: EGTX), today announced that the European Commission (EC) has approved Emcitate® (tiratricol) ...

EMA establishes regular procedure for scientific advice on certain high-risk medical devices: Amsterdam, The Netherlands Wednesday, February 12, 2025, 13:00 Hrs [IST] EMA, in clos ...

CATUMAXOMAB BECOMES THE ONLY APPROVED DRUG THERAPY FOR MALIGNANT ASCITES, A RARE AND DEBILITATING COMPLICATION OF ADVANCED-STAGE CANCER UNDER A LICENSING AGREEM ...

The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

Telethon Foundation is seeking approval for a gene therapy to treat the rare disease Wiskott-Aldrich syndrome.

Ocugen (OCGN) announced that the European Commission has provided a positive opinion from the EMA’s, or European Medicines Agency’s, Committee ...