Alexion Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the use of SOLIRIS (eculizumab), the company’s first C5 complement inhibitor, as a treatment for patients with neuromyelitis optica spectrum disorder (NMOSD) who have anti-aquaporin-4 (AQP4) auto antibodies.
The US Federal Trade Commission (FTC) and Israel-based Teva Pharmaceuticals Industries have reached a global settlement to resolve three separate federal court antitrust lawsuits involving the latter’s subsidiaries.
Innovation Pharmaceuticals said that the US Patent & Trademark Office has issued a new patent to the company for the treatment of oral mucositis.
Roche has secured priority review from the US Food and Drug Administration (FDA) for two of its investigational cancer drugs, the selective tyrosine kinase inhibitor entrectinib (RXDX-101) and the anti-CD79b antibody drug conjugate (ADC) polatuzumab vedotin.
Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda (pembrolizumab) as the adjuvant treatment for patients with melanoma with involvement of lymph node(s) following complete resection.
Pfizer announced that the European Commission (EC) has approved ZIRABEV for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma of the cervix.
The US Food & Drug Administration (FDA) has refused to give its approval to Motif Bio’s skin disorder drug iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
Novartis has secured approval from the US Food and Drug Administration (FDA) for its Egaten (triclabendazole) to treat fascioliasis in patients six years of age and older.
The US Food and Drug Administration has posted 12 warning letters and 5 online advisory letters issued to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions.
The US court has cleared way for Dr. Reddy's Laboratories to launch generic version of Indivior’s Suboxone (buprenorphine and naloxone) sublingual film, which is an opioid addiction treatment.
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