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Home » Topics » Drugs » Submissions and Approvals

Submissions and Approvals
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FDA Denies Akebia’s Vadadustat Appeal but Suggests a Path Forward

June 6, 2023
There are no reports of complications in use of the drug in Japan in the two years since approval there, the company said. Read More

FDA Approves Lynparza Combination for Certain Metastatic Prostate Cancer

June 5, 2023
Approval was based on phase 3 trial results that showed improvement in progression-free and overall survival. Read More

FDA Denies Akebia’s Vadadustat Appeal but Suggests a Path Forward

June 2, 2023
Persisting first through an FDA complete response letter (CRL), and then through a denial of a formal dispute resolution request, Akebia Pharmaceuticals is now counting on Japanese postmarketing safety data to get vadadustat, its chronic kidney disease (CKD) anemia drug, over the finish line in the U.S. Read More

FDA Approves Pfizer Abrysvo RSV Vaccine for Older Adults

June 2, 2023
The company plans to initiate additional trials with children and high risk adults. Read More

CMS Says It Will Cover Antiamyloid Antibodies With Final FDA Approval

June 1, 2023
Medicare will pay for treatment with any antiamyloid antibody that is fully approved by the FDA and administered as part of a national registry run by CMS, according to the agency. Read More

Lexicon’s Once-a-Day Tablet to Reduce Risks of Heart Failure Gets FDA Approval

June 1, 2023
Twenty-five percent of heart failure patients are re-hospitalized within 30 days of discharge, the company said. Read More

Blue Earth’s Radiohyrid PET Imaging Agent for Prostate Cancer Gets FDA Approval

May 31, 2023
Posluma uses two different molecules to target the cancer and enable imaging. Read More

CHMP Recommends Pulling Novartis Sickle Cell Drug, Approves Two Other Drugs

May 30, 2023
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended pulling a Novartis sickle cell disease drug from the market and approving two others to diagnose prostate cancer and treat a certain form of epilepsy. Read More

Paxlovid Receives FDA Approval for COVID-19

May 30, 2023
The drug showed an 86 percent reduction in risk of hospitalization or death. Read More

Janssen’s Milvexian Gets Fast Track Designation for Three Cardiac Indications

May 26, 2023
The drug is being studied among 50,000 patients in three parallel trials. Read More

FDA Approves Innoviva’s IV Treatment for Difficult-to-Treat Bacterial Pneumonia

May 25, 2023
One of the two drugs in the treatment is related to penicillin, and the other is a protective agent. Read More

Invidior’s Opvee Opioid Overdose Nasal Spray Gets FDA Approval

May 24, 2023
The company expects to market the product in Q4 2023. Read More
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