USFDA

Mersana Therapeutics, Inc., a biotechnology company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) based on its proprietary Fleximer® platform technology,  announced that the U.S. Food and Drug Administration (FDA) cleared the company’s Investigational New Drug (IND) application to begin Phase 1 clinical trials for its lead oncology drug candidate XMT-1522.The compound is Mersana’s first pipeline product, and defines a new class of HER2-targeted therapies.

Bristol Meyer Squibb Companyannounced  that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo to patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) that has progressed on or after platinum-containing therapy. The FDA granted the application priority review and previously granted Opdivo Breakthrough Therapy Designation for mUC in June 2016, reinforcing the need for new treatment approaches in this patient population. The FDA action date is March 2, 2017.

CEL-SCI Corporation announced  that company received the Partial Clinical Hold letter from the U.S. Food and Drug Administration (FDA). CEL-SCI has started working on a response to the FDA and will work diligently with the FDA to seek to have the partial clinical hold lifted.

Keystone Nano, a company is working at the interface between nanotechnology and the life sciences, has received orphan drug status for the use of Ceramide to treat liver cancer from the US FDA. 

AstraZeneca announced that the US Food and Drug Administration (FDA) has accepted a complete re-submission of a New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), a potential new medicine for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. The FDA has indicated that this is a complete class 2 response.

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 3, 2017.

Eli Lilly and Company announced  that the U.S. Food and Drug Administration (FDA) has granted approval of LARTRUVO™ (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. LARTRUVO's indication is approved under Accelerated Approval, and is based on data from the Phase 2 portion of the pivotal JGDG trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Lannett Company, Inc. received a notice from the U.S. Food and Drug Administration (FDA) that it will seek to withdraw approval of the Company's Abbreviated New Drug Application (ANDA) for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) Tablets. 

Biotricity inc has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a key component of its solution. This clearance is another watershed moment in the company’s quest to market its remote cardiac monitoring solution comprised of the bioflux software and device. By developing medical remote monitoring solutions that help prevent and manage chronic diseases, biotricity seeks to revolutionize the health industry by bridging the gap in chronic care management.

Marksans Pharma Limited hereby announces that USFDA has granted approval for an Abbreviated New Drug Application (ANDA) for Paricalcitol Capsules 1 meg, 2 meg and 4 meg.