Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy,

Amgen (NASDAQ:AMGN), Cytokinetics, Incorporated (NASDAQ:CYTK) and Servier today announced that the Data Monitoring Committee (DMC) for GALACTIC-HF recently completed the second and final planned interim analysis, which included consideration of pre-specified criteria for futility and superiority.

AstraZeneca has agreed to sublicense its global rights to Movantik (naloxegol), excluding Europe, Canada and Israel, to RedHill Biopharma (RedHill). Movantik is a peripherally acting mu-opioid receptor antagonist (PAMORA) indicated for the treatment of opioid-induced constipation (OIC).

Clover Biopharmaceuticals, a China based global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, announced today that it has entered into a research collaboration with GSK for its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer).

GlaxoSmithKline (LSE/NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults (18 years and older).

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without

Novartis announced that the US Food and Drug Administration (FDA) accepted and granted Priority Review to capmatinib’s (INC280) New Drug Application (NDA). Capmatinib is a MET inhibitor being evaluated as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC)(1).