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FDA to ask panel if Aimmune peanut allergy treatment data support approval

See the rest of the story here. Theflyonthewall.com provides the latest financial news as it breaks. Known as a leader in market intelligence, The Fl.....»»

Category: blogSource: theflyonthewallSep 11th, 2019

Peninsula drug company takes big step toward peanut allergy drug approval

Aimmune Therapeutics Inc.'s quest to sell the first biologic drug to treat peanut allergies won a regulatory advisory committee's blessing Friday, moving the company closer to Food and Drug Administration approval. The action by the nine-member panel do.....»»

Category: topSource: bizjournalsSep 16th, 2019

FDA panel recommending approval of first peanut allergy treatment for kids

An estimated 1.6 million children and teenagers would be eligible for the medication, to be sold as Palforzi.....»»

Category: topSource: usatodaySep 13th, 2019

Aimmune"s stock halted as FDA panel"s decision awaited on peanut allergy treatment

Aimmune Therapeutics Inc.'s stock has been halted for news Friday, as the Food and Drug Administration's Allergenic Products Advisory Committee (APAC) is meeting a.....»»

Category: topSource: marketwatchSep 13th, 2019

Good News, Bad News in the War on Peanut Allergy

Aimmune shares dipped on Monday after the FDA's Allergenic Products Advisory Committee voted to support the use of AR101 (Palforzia) in children and teens with peanut allergy......»»

Category: blogSource: 247wallst22 hr. 40 min. ago

FDA committee votes to support use of Aimmune"s Palforzia for peanut allergy

See the rest of the story here. Theflyonthewall.com provides the latest financial news as it breaks. Known as a leader in market intelligence, The Fl.....»»

Category: blogSource: theflyonthewallSep 13th, 2019

FDA panel votes 8-1 saying Aimmune peanut allergy drug Palforzia is safe

See the rest of the story here. Theflyonthewall.com provides the latest financial news as it breaks. Known as a leader in market intelligence, The Fl.....»»

Category: blogSource: theflyonthewallSep 13th, 2019

FDA panel votes 7-2 saying Aimmune"s peanut allergy drug Palforzia works

See the rest of the story here. Theflyonthewall.com provides the latest financial news as it breaks. Known as a leader in market intelligence, The Fl.....»»

Category: blogSource: theflyonthewallSep 13th, 2019

Aimmune jumps as FDA materials seen as good sign for peanut allergy treatment

See the rest of the story here. Theflyonthewall.com provides the latest financial news as it breaks. Known as a leader in market intelligence, The Fl.....»»

Category: blogSource: theflyonthewallSep 11th, 2019

Aimmune Therapeutics Could Achieve Regulatory Firsts With Peanut Allergy Treatment

Aimmune Therapeutics Could Achieve Regulatory Firsts With Peanut Allergy Treatment.....»»

Category: topSource: seekingalphaMar 26th, 2019

Peninsula biotech lines up chance to crack the peanut allergy nut

After asking U.S. regulators to approve its peanut-desensitizing treatment and completing a late-stage trial in Europe, Aimmune Therapeutics Inc. is poised to bring to market the first broadly effective drug to help peanut allergy patients fend off ac.....»»

Category: topSource: bizjournalsMar 25th, 2019

Aimmune to present data on peanut allergy, PALISADE trial

See the rest of the story here. Theflyonthewall.com provides the latest financial news as it breaks. Known as a leader in market intelligence, The Fl.....»»

Category: blogSource: theflyonthewallMay 15th, 2018

Aimmune announces new clinical data on AR101 for Peanut Allergy

See the rest of the story here. Theflyonthewall.com provides the latest financial news as it breaks. Known as a leader in market intelligence, The Fl.....»»

Category: blogSource: theflyonthewallMay 28th, 2018

Stifel: DBV Tech Shares Attractive Ahead Of Potential 2019 Approval For Peanut Allergy Drug

Shares of DBV TECHNOLOGIE/S ADR (NASDAQ: DBVT), a clinical-stage biotech developing treatment options for food allergies, present a favorable risk-reward profile over the next 12 months, according to Stifel. Latest Ratings for DBVT DateFirmAction.....»»

Category: blogSource: benzingaSep 14th, 2018

Aimmune submits AR101 BLA to FDA for treatment of peanut allergy

See the rest of the story here. Theflyonthewall.com provides the latest financial news as it breaks. Known as a leader in market intelligence, The Fl.....»»

Category: blogSource: theflyonthewallDec 21st, 2018

Aimmune to present AR101 and peanut allergy data at AAAAI

See the rest of the story here. Theflyonthewall.com provides the latest financial news as it breaks. Known as a leader in market intelligence, The Fl.....»»

Category: blogSource: theflyonthewallFeb 4th, 2019

Analyst: DBV"s Peanut Allergy Drug Could Outscore Aimmune"s On Safety Front

Aimmune Therapeutics Inc (NASDAQ: AIMT)'s peanut allergy product candidate Palforzia to treat peanut allergy in children and adolescents has received .....»»

Category: blogSource: benzinga17 hr. 11 min. ago

FDA rejects Sarepta"s second Duchenne drug

The FDA has denied Sarepta Therapeutics’ application for its second Duchenne muscular dystrophy treatment, despite the company producing twice the amount of data behind its controversial first product approval in 2016. Sarepta (Nasdaq: SRPT) had .....»»

Category: topSource: bizjournalsAug 19th, 2019

Novartis to answer U.S. Senate demand for data manipulation details

Novartis plans to answer a U.S. senator who demanded details about data manipulation related to its gene therapy Zolgensma, amid scrutiny of the Swiss drugmaker's decision to delay informing regulators until after the treatment's approval......»»

Category: topSource: reutersAug 19th, 2019

Revolutionary Peanut Allergy Treatment Is One Step Closer

DBV Tech shares shot up on Thursday after the company announced the submission of paperwork to the FDA for Viaskin Peanut for the treatment of peanut-allergic children......»»

Category: blogSource: 247wallstAug 8th, 2019

FDA: Novartis Hid Data Manipulation While Seeking Approval of $2.1 Million Drug

A Novartis AG unit that developed a breakthrough gene therapy knew about potential manipulation of animal testing data but failed to disclose it to regulators before the treatment was approved, the U.S. Food and Drug Administration said......»»

Category: topSource: moneycentralAug 6th, 2019