FDA Approvals

Aurobindo Pharma Limited is pleased to announce that the company has received tentative approval from the U.S. FDA under the U.S. President’s Emergency Plan...

Ritter Pharmaceuticals Announces Phase 3 Plans after its End of Phase 2 Meeting with FDA on RP-G28 for Lactose Intolerance

FDA Approvals

Ritter Pharmaceuticals, a developer of novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, today announced its Phase 3 plans...

Aurobindo Pharma receives USFDA Approval for Sevela mer Carbonate tablets

Americas

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture...

First FDA-Approved Treatment for ALS in 22 Years Now Available in U.S

Americas

Mitsubishi Tanabe Pharma America, Inc. announced RADICAVA ™ (edaravone), an intravenous therapy indicated for all adult patients diagnosed with amyotrophic lateral sclerosis (ALS), also known as...

Samumed Receives Orphan Drug Designation from FDA for SM04646

FDA Approvals

Samumed announced that the U.S. FDA has granted SM04646, a novel small molecule Wnt pathway inhibitor, an Orphan Drug Designation (ODD) for IPF: http://bit.ly/2gStpOf...

FDA chooses Zepsyre from PharmaMar to explore potential development for pediatric cancers

FDA Approvals

The Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) of the FDA, has invited PharmaMar to participate in this ODAC, giving a presentation to...

Takeda Announces FDA Accelerated Approval of ALUNBRIGTM (brigatinib)

FDA Approvals

Takeda Pharmaceutical Company Limited announced that ALUNBRIG™ (brigatinib) has received Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the treatment of...

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