Regulation

Roche secures FDA priority review for entrectinib and polatuzumab vedotin

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 gets FDA nod for Keytruda as adjuvant treatment for melanoma

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 secures approval from European Commission for Avastin biosimilar

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.

FDA declines to approve Motif Bio’s iclaprim for ABSSSI treatment

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).

FDA approves Novartis’ Egaten to treat fascioliasis

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.

FDA takes action against 17 firms for illegally selling products that claim to treat Alzheimer’s disease

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.

US court rejects Indivior’s appeal on Suboxone generic version

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.

Finch gets FDA breakthrough therapy status for CP101 to treat recurrent C. Difficile infection

Finch Therapeutics Group has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational drug CP101 to treat patients with recurrent Clostridium difficile (C. difficile) infection.

FDA extends review period for Incyte’s GVHD treatment Jakafi

The US Food and Drug Administration (FDA) has extended the review period for Incyte’s supplemental new drug application (sNDA) for acute graft-versus-host disease (GVHD) treatment Jakafi (ruxolitinib).