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RSS FeedPosted by Michael Wonder on 17 Jun 2017
Adamis wins U.S. approval to sell EpiPen rival, shares soar
15 June 2017 - Adamis Pharmaceuticals said on Thursday it received U.S. approval for its emergency epinephrine syringes to treat ...
Posted by Michael Wonder on 14 Jun 2017
How creative FDA regulation led to first-in-the-world approval of a cutting edge heart valve
14 June 2017 - Nearly six years ago FDA approved an artificial transcatheter heart valve to treat patients having severe ...
Posted by Michael Wonder on 12 Jun 2017
Coherus Biosciences receives complete response letter from FDA for its biologics license application for CHS-1701 (pegfilgrastim biosimilar candidate)
12 June 2017 - Coherus BioSciences today announced that the U.S. FDA has issued a complete response letter for its ...
Posted by Michael Wonder on 10 Jun 2017
FDA approves first generic of drug for prevention of HIV and to treat HIV-1
9 June 2017 - On 8 June 2017, the U.S. FDA approved the first generic version of Truvada for the ...
Posted by Michael Wonder on 09 Jun 2017
Bristol-Myers Squibb receives accelerated approval of Opdivo (nivolumab) from the US FDA
22 December 2014 - First approval of Opdivo in the US. ...
Posted by Michael Wonder on 09 Jun 2017
Aeolus announces FDA fast track designation granted to AEOL 10150 for treatment of patients with lung acute radiation syndrome following a radiologial or nuclear event
8 June 2017 - Aeolus Pharmaceuticals announced today that the U.S. FDA has granted fast track designation to AEOL 10150 for ...
Posted by Michael Wonder on 08 Jun 2017
FDA requests removal of Opana ER for risks related to abuse
8 June 2017 - Today, the U.S. FDA requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER ...
Posted by Michael Wonder on 08 Jun 2017
Bristol-Myers Squibb announces availability of new Orencia (abatacept) subcutaneous administration option for patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis
8 June 2017 - New pre-filled syringe option can be administered at home. ...
Posted by Michael Wonder on 08 Jun 2017
Biosimilar drugs offer promise for drug price savings, but risks remain
5 June 2017 - The issue of prescription drug prices continues to top the list of public concerns about health ...
Posted by Michael Wonder on 08 Jun 2017
FDA expands approved use of Opdivo to treat lung cancer
4 March 2015 - The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat ...
Posted by Michael Wonder on 08 Jun 2017
Bristol-Myers Squibb receives approval from the US FDA for the Opdivo (nivolumab) + Yervoy (ipilimumab) regimen in BRAF V600 wild-type unresectable or metastatic melanoma
30 September 2015 - First and only FDA approved combination of two immuno-oncology agents. ...
Posted by Michael Wonder on 08 Jun 2017
Bristol-Myers Squibb announces US FDA approval for Opdivo (nivolumab) as a single agent for the treatment of patients with previously untreated BRAF wild-type advanced melanoma
24 November 2015 - First and only PD-1 immune checkpoint inhibitor approved as a single agent for first-line use in advanced ...
Posted by Michael Wonder on 08 Jun 2017
Novartis receives two new FDA approvals for Cosentyx to treat patients with ankylosing spondylitis and psoriatic arthritis in the US
15 January 2016 - FDA approval for Cosentyx is based on efficacy and safety outcomes shown across four Phase III studies, ...
Posted by Michael Wonder on 08 Jun 2017
Mateon Therapeutics receives FDA fast track designation for OXI4503 in patients with acute myeloid leukaemia
7 June 2017 - Mateon Therapeutics today announced that the U.S. FDA has granted fast track designation to the company's product ...
Posted by Michael Wonder on 07 Jun 2017
Calithera Biosciences announces FDA fast track designation granted to CB-839 for treatment of patients with renal cell carcinoma
Calithera Biosciences today announced that the U.S. FDA has granted fast track designation to CB-839 in combination with everolimus, for ...