Tag: FDA

Business

Mediwound Ltd (NASDAQ: MDWD) Obtains Complete Response Letter from U.S. FDA for NexoBrid Biologics Authorization Presentation

Mediwound Ltd (NASDAQ: MDWD) today announced it obtained a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning the Biologics License Application (BLA). The company was looking for endorsement of NexoBrid® for eschar removal (debridement) in grownups with profound partial-thickness and full-thickness thermal burns.  FDA communicates […]

Business

Tonix Pharmaceuticals Holdings Corp (NASDAQ: TNXP) Announce Plans to Study TNX-102 SL In Long COVID Treatment; Shares Drop 6%

Tonix Pharmaceuticals Holdings Corp (NASDAQ: TNXP) stock dropped 6.56% after the company announced plans to develop TNX-102 SL as a possible Long COVID Syndrome treatment. Long COVID is known as the Post-Acute Sequelae of COVID-19. Tonix to meet FDA in Q3 to discuss TNX-102 SL in Long COVID treatment The […]

Business

U.S. FDA Declines to Approve Avenue Therapeutics Inc’s (NASDAQ: ATXI) Painkiller Again, Shares Drop

The U.S. Food and Drug Administration has once again declined to approve Avenue Therapeutics Inc’s (NASDAQ: ATXI) painkiller tramadol noting that it was not safe for the intended population. The announcement saw Avenue’s share drop by 5% in premarket trading.  According to the FDA, intravenous (IV) tramadol showed delayed and […]

Business

Eton Pharmaceuticals Inc (NASDAQ: ETON) Gains FDA Endorsement For Recipes

Eton Pharmaceuticals Inc (NASDAQ: ETON) announced that the U.S. Food and Drug Administration (FDA) has accepted Rezipres® (ephedrine hydrochloride injection) for the treatment of clinically vital hypotension happening in the background of anesthesia. The company shares were up 7.06% at $6.98 on Tuesday. “We are happy to see the consent […]

Business

Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) Up 6.93% After FDA Accepts to Review its ZIMHI NDA

Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) gained 6.93% following the announcement that the FDA had accepted to review its resubmitted New Drug Application for ZIMHI™. ZIMHI is a higher naloxone injection product candidate under development by the company for opioid overdose treatment. It lost 5.56% in the last trading session. The […]

Business

Liminal BioSciences Inc (NASDAQ: LMNL) Receives FDA Approval For Its Ryplazim To Cure Patients With Type 1 Hypoplasminogenia

The US FDA approved Ryplazim of Prometic Biotherapeutics Inc, a subsidiary of Liminal BioSciences Inc (NASDAQ: LMNL), to treat patients suffering from hypoplasminogenia.  Ryplazim is the first approved drug in the market to treat this rare genetic disorder. Liminal assessed Ryplazim efficacy in adult patients and pediatric patients with hypoplasminogenia […]

Business

Will Soleno Therapeutics, Inc. (NASDAQ: SLNO) Sail Through From Here?

Clinical-stage biopharmaceutical company Soleno Therapeutics, Inc. (NASDAQ: SLNO) recently announced that its drug DCCR (diazoxide choline) Extended-Release tablets has received Orphan Drug Designation from U.S. Food and Drug Administration (FDA). The drug is to be used for the treatment of von Gierke disease, scientifically called Glycogen Storage Disease Type 1a […]