Regulation

FDA approves Janssen’s Spravato CIII nasal spray to treat depression

The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the US Food and Drug Administration (FDA) for its Spravato (esketamine) CIII nasal spray for adults with treatment-resistant depression (TRD).

US FDA grants priority review for Fedratinib new drug application in myelofibrosis

Celgene announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for fedratinib and granted a Priority Review.

Pfizer’s lung cancer drug Lorviqua recommended for marketing authorization in EU

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Pfizer’s Lorviqua (lorlatinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers

Roche announced that the US Food and Drug Administration (FDA) has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection to treat certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease.

AstraZeneca gets FDA expanded approval for Farxiga and Xigduo XR

AstraZeneca has secured expanded approval from the US Food and Drug Administration (FDA) for Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin and metformin HCl extended-release) to treat type 2 diabetes (T2D) and moderate renal impairment.

FDA grants priority review and accepts sBLA of SOLIRIS as treatment for NMOSD

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.

FTC, Teva reach global settlement to resolve reverse-payment charges

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 receives new patent for compounds for use in treatment of oral mucositis

Innovation Pharmaceuticals said that the US Patent & Trademark Office has issued a new patent to the company for the treatment of oral mucositis.

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.