Blog
RSS FeedPosted by Michael Wonder on 03 Oct 2018
FDA approves Seysara (sarecycline) for the treatment of moderate to severe acne
2 October 2018 - To be launched in U.S. by Almirall SA. ...
Posted by Michael Wonder on 03 Oct 2018
Paratek announces FDA approval of Nuzyra (omadacycline)
2 October 2018 - First and only once-daily IV and oral antibiotic approved to treat both CABP and ABSSSI patients in ...
Posted by Michael Wonder on 03 Oct 2018
ADMA Biologics resubmits biologics license application for RI-002
1 October 2018 - ADMA Biologics announces that the Company has responded to the July 2016 complete response letter and ...
Posted by Michael Wonder on 02 Oct 2018
Clovis Oncology receives breakthrough therapy designation for Rubraca (rucaparib) for treatment of BRCA1/2-mutated metastatic castration resistant prostate cancer
2 October 2018 - Breakthrough therapy designation granted to Rubraca based on initial data from on-going TRITON2 Phase 2 study in ...
Posted by Michael Wonder on 02 Oct 2018
Statement from FDA Commissioner on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions
2 October 2018 - When I announced the Drug Competition Action Plan, or DCAP, in June 2017, I committed the ...
Posted by Michael Wonder on 02 Oct 2018
FDA approves Kyprolis (carfilzomib) once weekly 70 mg/m2 in combination with dexamethasone for patients with relapsed or refractory multiple myeloma
1 October 2018 - Application reviewed and approved under FDA's real-time oncology review and assessment aid pilot programs. ...
Posted by Michael Wonder on 02 Oct 2018
FDA grants rare paediatric disease designation to pegzilarginase for arginase 1 deficiency
1 October 2018 - Aeglea eligible to receive a priority review voucher. ...
Posted by Michael Wonder on 01 Oct 2018
Statement from FDA Commissioner on FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients
1 October 2018 - The threat of cyber attacks is no longer theoretical. Cyber criminals and adversaries can inflict significant ...
Posted by Michael Wonder on 01 Oct 2018
Antares receives FDA approval of Xyosted (testosterone enanthate) injection for testosterone replacement therapy in adult males
1 October 2018 - A novel subcutaneous auto-injector product approved for once weekly at-home therapy. ...
Posted by Michael Wonder on 01 Oct 2018
Shield Therapeutics announces submission of a new drug application for Feraccru with the US FDA
1 October 2018 - Shield Therapeutics today announces that it has received confirmation from the US FDA of its successful ...
Posted by Michael Wonder on 01 Oct 2018
Congratulations. Your study went nowhere.
23 September 2018 - Researchers should embrace negative results instead of accentuating the positive, which is one of several biases that ...
Posted by Michael Wonder on 01 Oct 2018
Adamis Pharmaceuticals receives FDA approval for its lower dose Symjepi product
27 September 2018 - Adamis Pharmaceuticals Corporation today announced that the U.S. FDA has approved Adamis’ lower dose version (0.15 ...
Posted by Michael Wonder on 01 Oct 2018
HighTide Therapeutics receives fast track designation from the U.S. FDA for HTD1801 treating primary sclerosing cholangitis
27 September 2018 - HighTide Therapeutics announced that the U.S. FDA has granted fast track designation to its investigational new drug, ...
Posted by Michael Wonder on 01 Oct 2018
Intra-Cellular Therapies completes submission of new drug application for lumateperone for treatment of schizophrenia
28 September 2018 - Intra-Cellular Therapies today announced that the company has completed the rolling submission of its new drug application ...
Posted by Michael Wonder on 01 Oct 2018
FDA approves Genentech's Xolair (omalizumab) pre-filled syringe formulation
28 September 2018 - The 75 mg/0.5 mL and 150 mg/1 mL single-dose pre-filled syringes are expected to be available by ...