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- Read more about Oragenics Receives Supportive FDA Feedback for Initiating a Phase 2 Study Protocol
Oragenics announced that it has received feedback from the U.S. Food and Drug Administration (FDA) in response to the Company’s request for a Type C meeting, concerning Phase 2 study protocols for the Company’s OM therapeutic candidate, AG013. As part of the clinical protocol for the study, Oragenics expects to file the Investigational New Drug (IND) update in late 2016 and initiate the study with AG013 in the United States and Europe during early 2017.
- Read more about Cempra Present Solithromycin at FDA Antimicrobial Drugs Advisory Committee Meeting
Cempra, Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Antimicrobial Drugs Advisory Committee on November 4, 2016 in Silver Spring, Maryland to discuss the safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia (CABP).
- Read more about Tonix Pharmaceuticals complete End-of-Phase 2 Meeting with FDA for TNX-102 SL
Tonix Pharmaceuticals Holding Co. which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), announced that it has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) from an End-of-Phase 2/Pre-Phase 3 meeting. These minutes confirmed the FDA’s acceptance of Tonix’s proposed Phase 3 studies and the planned New Drug Application (NDA) data package to support the registration of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of PTSD.
- Read more about US FDA grants 510(k) clearance to Bio2 Medical's Angel Catheter
Bio2 Medical has announced that the Angel Catheter has received 510(k) clearance from the United States Food & Drug Administration (FDA). This 510(k) clearance includes a first ever, prophylactic indication for a medical device to protect critically ill patients at high-risk for pulmonary embolism (PE) and contraindicated for anticoagulation. The Angel Catheter provides a novel alternative to IVC filters for PE protection in a vast patient population that has historically been underserved. The device is designed for bedside placement, without the need for fluoroscopic guidance, and is designed to be safely retrieved in all cases once no longer indicated.

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- Read more about Strides Shasun receives USFDA nod for Ranitidine Tablets
Strides Shasun Limited announced that it has received approval from the United States Food & Drug Administration (USFDA) for Ranitidine Tablets USP, 150 mg and 300 mg.
- Read more about Strides Shasun receives US FDA grant for polyethylene glycol 3350, powder for solution
Strides Shasun Limited has received approval from the United States Food & Drug Administration (FDA) for polyethylene glycol 3350, powder for solution 17 grams/capful and 17 grams/packet (OTC).
- Read more about FDA issue guidance of testing for Zika virus in all donated blood and blood components in the US
U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
- Read more about Mallinckrodt’s Synacthen® Depot IND Application Receives FDA Fast-Track Designation
Mallinckrodt plc announced the U.S. Food and Drug Administration (FDA) has granted the company's request for a Fast Track designation for its Investigational New Drug (IND) application for Synacthen® Depot in the treatment of Duchenne muscular dystrophy (DMD). Synacthen Depot is a depot formulation of Synacthen (tetracosactide), a synthetic 24 amino acid melanocortin receptor agonist. Synacthen Depot is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions, but has never been approved for use in patients in the U.S.
- Read more about U.S. FDA provide update on Zealand pharma’s iGlarLixi, for type 2 diabetes patients
Zealand Pharma (Zealand) announced that Sanofi has submitted updated information on the pen delivery device for iGlarLixi to the U.S. Food and Drug Administration (FDA) as part of the New Drug Application (NDA) for the product. IGlarLixi is a once-daily, fixed-ratio combination of lixisenatide (AdlyxinTM) and insulin glargine 100 Units/mL (Lantus®) for the treatment of adults with type 2 diabetes.
- Read more about FDA Approves Pfizer’s TROXYCAER Capsules
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, for oral use, CII for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. TROXYCA ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. However, abuse of TROXYCA ER by these routes is still possible. It is the only oxycodone with oral abuse-deterrent features described in the labeling.

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