The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
Sunovion announced the FDA issued a Complete Response Letter for the NDA for dasotraline, a novel dual-acting DNRI, for the treatment of ADHD.
read more
Thursday, August 30, 2018
Regenxbio announced it is developing a new product candidate, RGX-181, for the treatment of late-infantile neuronal ceroid lipofuscinosis type 2 ...
read more
Thursday, August 30, 2018
Sophiris Bio announced the conclusion of the ongoing investigation into the previously reported death of a patient in the company's Phase 2b trial for...
read more
Wednesday, August 29, 2018
Trovagene announced the EC has endorsed the positive opinion of the COMP and has granted Orphan Drug Designation for Onvansertib.
read more
Wednesday, August 29, 2018
INP105 is being studied for the treatment of acute agitation in bipolar I disorder and schizophrenia.
read more
Mallinckrodt and NPXe announced the FDA recently granted Fast Track designation to NPXe's Phase 3 trial of xenon gas for inhalation in Post Cardiac ...
read more
The U.S. Food and Drug Administration (FDA) announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis to ...
read more
Thursday, August 23, 2018
Pfizer and Astellas announced amendments to the protocols for two registrational Phase 3 trials, designed to evaluate the safety and efficacy of ...
read more
Wednesday, August 22, 2018
Allergan announced it received a Complete Response Letter from the FDA in response to the NDA for ulipristal acetate for the treatment of abnormal ...
read more
Thursday, August 16, 2018
Regeneron and Teva announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with...
read more
The FDA approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-...
read more
Thursday, August 09, 2018
60 Degrees Pharmaceuticals (60P) announced the FDA approval of Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years ...
read more
Ionis announced the EMA) has granted PRIME designation to IONIS-HTTRx (also known as RG6042) for the treatment of people with Huntington's disease (HD...
read more
Janssen Research & Development
The FDA has approved Symtuza, the first and only complete, darunavir-based single-tablet regimen for the treatment of HIV-1 in treatment-naïve and ...
read more
Therapix Biosciences announced positive results in its pre-clinical studies evaluating THX-160, a novel pharmaceutical CB2 Receptor agonist for the ...
read more