Blog
RSS FeedPosted by Michael Wonder on 07 Jun 2018
FDA approves Genentech’s Rituxan (rituximab) for pemphigus vulgaris
7 June 2018 - Rituxan is now FDA-approved to treat four auto-immune diseases. ...
Posted by Michael Wonder on 07 Jun 2018
Partner Therapeutics announces US FDA approval of Leukine (sargramostim) for the treatment of acute radiation syndrome
6 June 2018 - Partner Therapeutics announced the recent FDA approval of Leukine for the treatment of adult and paediatric ...
Posted by Michael Wonder on 05 Jun 2018
FDA expands Lilly's Alimta (pemetrexed) label to include combination with Keytruda (pembrolizumab) and carboplatin as first-line treatment for metastatic non-squamous non-small cell lung cancer, irrespective of PD-L1 expression
5 June 2018 - New approval based on KEYNOTE-021, cohort G1, results. ...
Posted by Michael Wonder on 04 Jun 2018
FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
4 June 2018 - The U.S. FDA today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the ...
Posted by Michael Wonder on 03 Jun 2018
FDA chief outlines new ways to speed cancer drug approvals
2 June 2018 - The U.S. FDA is taking steps to streamline the approval process for cancer drugs, reviewing clinical ...
Posted by Michael Wonder on 02 Jun 2018
Amgen statement on complete response letter from the U.S. FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab)
1 June 2018 - Amgen received a complete response letter from the US FDA in response to the biologics license ...
Posted by Michael Wonder on 02 Jun 2018
FDA approves Olumiant (baricitinib) 2 mg tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis
1 June 2018 - The approval of Olumiant is based on the Phase 3 clinical trial program that demonstrated efficacy for ...
Posted by Michael Wonder on 01 Jun 2018
Idelvion newly approved 3,500 IU vial to provide convenience to patients using larger volumes
31 May 2018 - New vial option delivers on CSL Behring’s promise to enhance current treatments and provide more alternatives to ...
Posted by Michael Wonder on 30 May 2018
TherapeuticsMD announces FDA approval of TX-004HR: Imvexxy (oestradiol vaginal inserts), the lowest dose vaginal oestrogen product approved for the treatment of moderate to severe dyspareunia due to menopause
30 May 2018 - Imvexxy's applicator-free self-administration was developed with the woman in mind. ...
Posted by Michael Wonder on 30 May 2018
FDA approves new treatment for moderately to severely active ulcerative colitis
30 May 2018 - The U.S. FDA today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely ...
Posted by Michael Wonder on 29 May 2018
UCB announces the approval of Cimzia (certolizumab pegol) for moderate-to-severe plaque psoriasis, representing an important new option for patients in the U.S.
27 May 2018 - The U.S. FDA approval of Cimzia (certolizumab pegol) for use in moderate-to-severe plaque psoriasis marks the entry ...
Posted by Michael Wonder on 26 May 2018
The risks and benefits of expedited drug reviews
23 May 2018 - The US FDA oversees several programs that expedite approval of certain drugs that treat serious conditions ...
Posted by Michael Wonder on 25 May 2018
Recro Pharma receives complete response letter from the FDA
24 May 2018 - Recro Pharma today announced it has received a complete response letter from the U.S. FDA Office ...
Posted by Michael Wonder on 25 May 2018
BioMarin receives standard approval for Palynziq (pegvaliase-pqpz) injection for treatment of adults with phenylketonuria, a rare enetic Disease
24 May 2018 - First enzyme therapy to treat phenylketonuria. ...
Posted by Michael Wonder on 24 May 2018
FDA grants breakthrough therapy designation for tafamidis for the treatment of patients with transthyretin cardiomyopathy
23 May 2018 - Pfizer announced today that tafamidis received breakthrough therapy designation from the US FDA for the treatment ...