The Latest Breaking News from FDA

FDA Rejects Amryt Pharma's Oleogel-S10 Application For Skin Blistering Disorder

Amryt Pharma Plc (NASDAQ: AMYT) has 

Benzinga · Feb 28, 2022

CorMedix Refiles DefenCath US Application For Catheter-Related Bloodstream Infections

CorMedix Inc (NASDAQ: CRMD) has resubmi

Benzinga · Feb 28, 2022

See Why Did InflaRx Pause Late-Stage Vilobelimab Trial In Chronic Skin Condition

InflaRx N.V. (NASDAQ: IFRX) has received an advice letter from the FDA about the vilobelimab Phase 3 program for hidradenitis suppurativa (HS), a condition that causes small, painful lumps to form under the skin. 

Benzinga · Feb 28, 2022

22nd Century Group Welcomes Dr. Robert Califf's Confirmation As FDA Commissioner

22nd Century Group, Inc. (NASDAQ: XXII) an agricultural biotechnology company focused on tobacco harm reduction, congratulated Dr.

Benzinga · Feb 25, 2022

FDA Approves Eli Lilly's Jardiance In Broader Heart Patient Population

The FDA approved Eli Lilly And Co (NYSE:LLY) and partner Boehringer Ingelheim's drug, Jardiance, for expanded use in reducing the risk of death and hospitalization for all patients with heart failure. Initially approved by the FDA in 2014 for type 2 diabetes patients, the drug's use was expanded last year in some adults living with heart failure…

Benzinga · Feb 25, 2022

The Daily Biotech Pulse: Lilly's Jardiance Gets Nod For Heart Failure, Pulmatrix Announces Reverse Split, Reata Awaits FDA Decision

Here's a roundup of top developments in the biotech space over the last 24 hours.

Benzinga · Feb 25, 2022

Editorial: FDA should pull ineffective pregnancy drug Makena until we know it works

The U.S. Food and Drug Administration accelerated the approval of a drug called Makena meant to prevent premature births. Now there’s mounting evidence that the drug does not work. The FDA should use its authority to pull Makena from the market until and unless the company that makes it can…

Los Angeles Times · Feb 25, 2022

Why Rhythm Pharmaceuticals Shares Are Falling Today

The FDA has extended the review period for Rhythm Pharmaceuticals Inc's (NASDAQ:RYTM) supplemental marketing application for Imcivree (setmelanotide) for obesity and control of hunger with Bardet-Biedl Syndrome (BBS) or Alström syndrome.  The Prescription Drug User Fee Act (PDUFA) goal date has been revised to June 16, 2022, from March 16. FDA requested additional subgroup analyses…

Benzinga · Feb 24, 2022

The Government's Coronavirus Response Was a Complete Failure. Who Will Be Held Accountable?

From the CDC to the FDA, there are too many missteps to list.

Reason · Feb 24, 2022

The Daily Biotech Pulse: Orphazyme Plunges On Regulatory Setback In Europe, Pulmonx Earnings Disappoint, Amicus Declines To Spin Off Genetic Medicine Company

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga · Feb 24, 2022