The Pharma Letter
The Pharma Letter @ThePharmaLetter ·
Three strikes. Aldeyra's shares have plunged after a third consecutive FDA rejection for reproxalap. At what point does persistence become a liability to shareholders? #FDA #biotech #drugdevelopment #clinicaltrials thepharmaletter.com/pharma-news/al…
Aldeyra shares plunge after third FDA rejection for reproxalap

US biotech Aldeyra Therapeutics (Nasdaq: ALDX) has received a third complete response letter from the American medicines regulator for its dry eye candidate reproxalap, sending shares down around 68%.

From thepharmaletter.com
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notrumpfascism.bsky.social
notrumpfascism.bsky.social @TrumpAlwaysLies ·
.@WhiteHouse @foxnewsalert The 'strangling angel' could return if #RFK Jr. succeeds: report rawstory.com/rfk-jr-vaccine… #Diphtheria #FDA #CDC #TrumpFasism must fail. @HouseGOP @SenateGOP #MAGA Don’t let one of the #OrangeFascist nut jobs kill your kids!
The 'strangling angel' could return if RFK Jr. succeeds: report

A new analysis warns that once-controlled childhood diseases could come roaring back if vaccine access declines – including diphtheria, a historic killer known as the “strangling angel.”Researchers...

From rawstory.com
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The Pharma Letter
The Pharma Letter @ThePharmaLetter ·
FDA approves @novonordisk's Awiqli — a once-weekly insulin that could meaningfully improve adherence for millions of type 2 diabetes patients. Another win for Novo as it expands well beyond GLP-1. #FDA #diabetes #insulin #pharma thepharmaletter.com/biotech-news/n…
Novo Nordisk’s Awiqli approved by FDA

Danish pharma major Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Awiqli (insulin icodec-abae) injection 700 units/mL, the first and only once-weekly, long-acting...

From thepharmaletter.com
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markethubnft.nft/
markethubnft.nft/ @markethubnft ·
Before #Trump leaves office, Would the American people want him to release 🤔 hidden documents on advanced technology under the vail of the #nationsecurityact labeled under secrecy and by the #FdA if it ment the betterment of humanity 🤔
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Healio Allergy and Asthma
Healio Allergy and Asthma @HealioAllergy ·
ICYMI📢: Age is no longer a factor in when to use neffy 1 mg @(@ars_pharma) for emergency treatment of type 1 allergic reactions per an #FDA approval to update the prescribing information.vist.ly/4wgkdT
FDA approves update to neffy 1 mg label, removing age requirement

The FDA approved an update to the neffy 1 mg prescribing information so that age is not a factor in when to use the epinephrine nasal spray for emergency treatment of type 1 allergic reactions,...

From healio.com
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BGO Software - The digital health lab
BGO Software - The digital health lab @BGOSoftware ·
Research indicates that approximately 25% of #FDA enforcement letters include violations related to data validity or fitness-for-purpose evidence. These failures typically stem from poor #lifecycle control.👇 #pharmamanufacturing #csvbgosoftware.com/blog/computer-…D
Computer System Validation (CSV) in Pharma Manufacturing

Computer Software Validation (CSV) in pharma explained — regulations, the V-Model, risk-based strategies, EU GMP Annex 11, and how BGO Software helps you stay inspection-ready.

From bgosoftware.com
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Davis Rackler
Davis Rackler @DRackler ·
New to biotech trading? Just published a free beginner's guide. Covers everything: PDUFA dates, CRLs, AdCom votes, NDA vs BLA, short squeezes, sell-the-news traps, and how to read a scanner card. No paywall on education. Learn first, trade smarter. submarinecatalyst.com/beginners-guid… #FDA
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CP2
CP2 @LuckyPenguin10 ·
I have a suggestion for you, @TMZ… — $QURE $RGNX #FDA
Adam Cochran (adamscochran.eth) Adam Cochran (adamscochran.eth) @adamscochran ·
Honestly I’d pay for a subscription to TMZ if they took their bloodhound paparazzi tactics to focus full time on keeping Congress accountable. It’s like the one place we need that level of scrutiny!
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