Pharma News - Chemdiv

AmMax Bio Announces AMB-05X Granted FDA Fast Track Designation for the Treatment of Tenosynovial Giant Cell Tumor (TGCT)

AmMax Bio, Inc. (“AmMax”), a private clinical-stage biopharmaceutical company developing innovative therapeutics in oncology, including targeting the colony-stimulating factor 1 receptor (CSF1R...

8 billions: CVS to Buy Signify Health in Deal Pushing Beyond Retail

CVS Health Corp. emerged as the winning bidder over potential suitors that had included UnitedHealth Group Inc., Amazon.com Inc. and Option Care Health Inc.

FDA Expands Approval of Vertex’s Orkambi to Include Younger Age Group

The FDA has expanded its approval of Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) to include children with cystic fibrosis (CF) between the ages of 12 and 24 months who are homozygous f...

AstraZeneca’s Imfinzi Gets Expanded FDA Approval for Advanced Biliary Tract Cancer

The FDA has granted expanded approval for AstraZeneca’s blockbuster drug Imfinzi (durvalumab) in combination with chemotherapy gemcitabine and cisplatin to treat adults with locally advanced or ...

Experimental drug combo inhibits growth of lethal lung cancer in mice

Small cell lung cancer (SCLC) is one of the deadliest forms of the disease, but now scientists may have a promising new avenue for treatment.

Amneal Submits NDA for IPX203 for Parkinson’s Disease

Amneal Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for its investigational candidate IPX203 for the treatment of patients with Parkinson’s disease. ...

FDA grants Orphan Drug status to Maze’s Pompe disease treatment

MZE001 is being assessed in a Phase I trial to evaluate the tolerability, safety, pharmacokinetics and pharmacodynamics.

Boehringer Ingelheim's Spevigo Bags First FDA Approval for Rare Skin Disease

The FDA has approved Boehringer Ingelheim's Spevigo (spesolimab) for generalized pustular psoriasis (GPP) flares in adults, making it the first drug approved for this indication. ...

Targeting $500M opportunity, Amneal files for FDA approval of extended-release Parkinson's prospect

Amneal Pharmaceuticals has filed for FDA approval of an extended-release Parkinson’s disease prospect that is tipped to deliver peak U.S. sales of up to $500 million. ...

Hepatitis of Unknown Origin Affecting Hundreds of Young Children

Research indicates that there is a growing amount of unusual hepatitis cases in children throughout Europe.

Merck Gains Fast Track Designation for Its Investigational Anticoagulant

Merck’s investigational anticoagulant therapy MK-2060 has received Fast Track designation from the FDA for reducing the risk of major thrombotic cardiovascular events in patients with end-stage r...

FDA Opioid Review Slow to Produce Actionable Results

The long-awaited review of problematic opioid prescribing is taking longer than observers had hoped. Studies of this extended use of the pain medications have lagged for years beyond their expected...