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- Read more about FDA approves Axumin, a new diagnostic imaging agent to detect recurrent prostate cancer
The U.S. Food and Drug Administration approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment. Axumin is marketed by Blue Earth Diagnostics, Ltd., Oxford, United Kingdom
- Read more about FDA Approves Braeburn Pharmaceutical’s Probuphine Implant
Braeburn Pharmaceuticals announces that the U.S. Food & Drug Administration (FDA) approved Probuphine, the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day. Probuphine delivers buprenorphine continuously for up to six months and should be used as part of a complete treatment program to include counseling and psychosocial support.
- Read more about Novavax’ RSV F Vaccine Get Fast Track Designation from U.S. FDA for Older Adults
Novavax, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax’ RSV F-Protein nanoparticle vaccine candidate (RSV F Vaccine) for the protection of older adults (60 years of age and older).
- Read more about Seqirus FLUCELVAX QUADRIVALENT receives FDA approval
Seqirus announced that the US Food and Drug Administration (FDA) has approved FLUCELVAX QUADRIVALENT™(Influenza Vaccine),the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. The use of a four-strain influenza vaccine like FLUCELVAX QUADRIVALENT may now provide protection against both B lineages, which may lead to a decrease in the influenza burden.
- Read more about Symbiomix Therapeutics declare positive Phase 3 Trial result of SYM-1219 & Pre NDA meeting with FDA
Symbiomix announced positive results from the second pivotal trial of lead product candidate SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV). SYM-1219 (secnidazole) is a potent, next-generation 5-nitroimidazole antibiotic with superior pharmacokinetic properties that enable efficacy with significantly less total drug exposure than first generation nitroimidazoles, leading to excellent safety, tolerability and adherence.
- Read more about Viamet Receives Orphan Drug Designation from the FDA for VT-1598
Viamet Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted orphan drug designation to VT-1598 for the treatment of coccidioidomycosis, or Valley Fever. VT-1598 is a selective, orally available inhibitor of fungal CYP51 that has demonstrated high potency in preclinical studies against Coccidioides species, the fungal pathogens responsible for Valley Fever.
- Read more about DelMar Pharmaceuticals complete End-of-Phase 2 Meeting with FDA on VAL-083
DelMar Pharmaceutical Inc. announced the successful completion of an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA).

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- Read more about DS Biopharma develop DS102 for pulmonary disorders and NASH
DS Biopharma (DS) announced plans to develop its anti-fibrotic and anti-inflammatory compound DS102 in chronic obstructive pulmonary disease (COPD) patients as well as in non-alcoholic steatohepatitis (NASH) patients.
- Read more about FDA Accept Allergan’s NDA Filing for Oxymetazoline HCI Cream 1.0%
Allergan plc. announced that the New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults, has been accepted by the U.S. Food and Drug Administration (FDA) for standard review. Allergan expects the Prescription Drug User Fee Act (PDUFA) date to be in the first half of 2017.
- Read more about Zambon Launch Xadago in UK
Zambon S.p.A., an international pharmaceutical company committed to the CNS therapeutic area, and its partner Newron Pharmaceuticals S.p.A. (Newron), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the CNS and pain, announced the availability of Xadago (safinamide) in the United Kingdom.