Today, prominent investor rights law firm Bernstein Litowitz Berger & Grossmann LLP ("BLB&G") filed a class action lawsuit in the U.S. District Court for the Eastern District of Pennsylvania alleging ...
We have worked on human rights in Poland for more than a decade. This work includes documenting violations of the rights of ...
The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...
Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its 21-valent pneumococcal conjugate ...
Ocugen (OCGN) said it has received a positive opinion from EU regulators for Advanced Therapy Medicinal Product ...
Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the ...
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, ...
Imfinzi has been recommended for approval in the European Union, EU, as monotherapy for the treatment of adults with ...
The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.
The European Medicines Agency (EMA) has recommended granting marketing authorization for the pneumococcal vaccine Capvaxive ...