News & Comments

The FDA Clears Compugen’s and Bayer’s IND Application for Their Checkpoint Inhibitor Immunotherapy Product

Finally, we are hearing what we were constantly expecting to hear coming out of Compugen’s (CGEN) technological capability. Yesterday, the U.S. Food and Drug Administration (FDA) has cleared Bayer …

The FDA Approved a Combination of Two Products. Both Belong to Array Biopharma

The FDA approved Array BioPharma’s (ARRY) products Braftovi™ capsules in combination with Mektovi® tablets for unresectable or metastatic skin cancer melanoma with a BRAF or BRAFV mutation, …

Sarepta Announced Successful Results from a Preliminary Trial for Duchenne Muscular Dystrophy

Sarepta Therapeutics (SRPT) has news from preliminary Duchenne muscular dystrophy trials. Although the number of recruited patients was only three, the strong positive data excited the media and …

 

Today’s Highlights

Amgen and UCB Resubmit BLA to the FDA for the Approval of Evenity™ to Prevent or Heal Osteoporosis Bone Fracture in Postmenopausal Women

The BLA Includes Data from More Than 11,000 Patients Amgen (AMGN) and UCB (Euronext Brussels: UCB) resubmitted a Biologics License Application (BLA) …

Exelixis Liver Cancer Results Are Gratifying, So Do Not Worry If Some Pretend They Do Not Like Them

The New England Journal of Medicine (NEJM) published results from the CELESTIAL phase 3 pivotal trial of Exelixis (EXEL) product Cabometyx® …

Why Vertex Added Over $20 to its Stock Price Today

Health Canada Approves PrSYMDEKO™ For People Ages 12 and Older With Certain CFTR Gene Mutations Vertex (VRTX) announced that Health …

Exploring Two Clinical-Stage Firms with New Different Approaches to Treatments

SOPHIRIS BIO AND NANOBIOTIX SOPHIRIS BIO  Sophiris Bio (SPHS) has a product called Topsalysin (PRX302) in Phase 2 clinical trial for the treatment …

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Amgen and UCB Resubmit BLA to the FDA for the Approval of Evenity™ to Prevent or Heal Osteoporosis Bone Fracture in Postmenopausal Women

The BLA Includes Data from More Than 11,000 Patients Amgen (AMGN) and UCB (Euronext Brussels: UCB) resubmitted a Biologics License Application (BLA) to the U.S.FDA for the approval of their osteoporosis investigational …

Stories About Research, Clinical Trials Results and an FDA Ruling

The Week in Review

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