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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Investigational PD-1 immune checkpoint inhibitor nivolumab receives U.S. FDA breakthrough therapy designation for Hodgkin lymphoma
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has granted the investigational PD-1 immune checkpoint inhibitor ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic
The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, ...
Posted by Michael Wonder on 05 Aug 2015
BioMarin completes rolling NDA submission to FDA for drisapersen for treatment of Duchenne muscular dystrophy amenable to exon 51 skipping
BioMarin Pharmaceutical Inc. today announced completion of the rolling submission of a New Drug Application (NDA) to the United States Food ...
Posted by Michael Wonder on 05 Aug 2015
Apotex announces FDA has accepted for filing its biosimilar application for filgrastim (Grastofil)
Apotex Inc., a rising competitor in the global biosimilars market, announced today that, as of February 13th, 2015, the US ...
Posted by Michael Wonder on 05 Aug 2015
Juno T cell therapy for leukaemia granted FDA breakthrough therapy designation
Juno Therapeutics today announced that the FDA has granted Breakthrough Therapy Designation to the company’s JCAR015 chimeric antigen receptor product ...
Posted by Michael Wonder on 05 Aug 2015
Sanofi Pasteur announces FDA approval of Quadracel DTaP-IPV vaccine for children 4 through 6 years of age
Sanofi Pasteur, the vaccines division of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) has approved use ...
Posted by Michael Wonder on 05 Aug 2015
How much should cancer drugs cost?
One of the nation’s top cancer hospitals is challenging the pharmaceutical industry to adopt a more rational approach to drug ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves radiation medical countermeasure
On March 30, 2015, the FDA approved the use of Neupogen (filgrastim) to treat adult and pediatric patients acutely exposed to ...
Posted by Michael Wonder on 05 Aug 2015
Veloxis announces U.S. FDA approval of Envarsus XR for treatment of kidney transplant patients
Veloxis Pharmaceuticals A/S today announced U.S. Food and Drug Administration (FDA) approval of Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Teva’s Granix (tbo-filgrastim) injection for self-administration
Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has approved Granix (tbo-filgrastim) Injection for self-administration by patients and ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Blincyto to treat a rare form of acute lymphoblastic leukaemia
The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer, Merck and Bristol-Myers Squibb report solid results
Three major U.S. drug companies reported solid first-quarter results despite a strong dollar, amid signs that their investment in pricey ...
Posted by Michael Wonder on 05 Aug 2015
FDA expands approved use of Imbruvica for chronic lymphocytic leukemia
The U.S. FDA today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry ...
Posted by Michael Wonder on 05 Aug 2015
US FDA grants priority review for potential new indication for Brilinta
AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Afrezza to treat diabetes
The U.S. Food and Drug Administration today approved Afrezza (insulin human) inhalation powder, a rapid-acting inhaled insulin to improve glycemic ...