The 483

Tag

FDA

47 stories

Deals

Lilly Paid $1.26B to License Hanmi's GLP-2

Lilly Paid $1.26B to License Hanmi's GLP-2
Deals

Gilead Paid $3.15B for Tubulis; TUB-040 Posts 61% ORR

Gilead Paid $3.15B for Tubulis; TUB-040 Posts 61% ORR
FDA

FDA's First AI Warning Letter Hits Purolea Lab

FDA's First AI Warning Letter Hits Purolea Lab
FDA

How to Respond to an FDA Form 483 in 15 Days

How to Respond to an FDA Form 483 in 15 Days
FDA

Form 483 vs Warning Letter: What's the Difference

Form 483 vs Warning Letter: What's the Difference
FDA

Ousted: RFK Jr. Ends Makary's 13-Month FDA Tenure

Ousted: RFK Jr. Ends Makary's 13-Month FDA Tenure
FDA

FDA Cleared Lilly Foundayo in $9.3B Obesity Race

FDA Cleared Lilly Foundayo in $9.3B Obesity Race
FDA

Celcuity Beats Piqray in Phase 3, Shares Jump 15%

Celcuity Beats Piqray in Phase 3, Shares Jump 15%
FDA

FDA Clears Auvelity for Alzheimer's, $2.1B Peak

FDA Clears Auvelity for Alzheimer's, $2.1B Peak
FDA

FDA Cleared Regeneron's Otarmeni; Last Big Pharma Signs MFN Deal

FDA Cleared Regeneron's Otarmeni; Last Big Pharma Signs MFN Deal
FDA

Trump Backs FDA Push to Fast-Track Psychedelic Treatments

Trump Backs FDA Push to Fast-Track Psychedelic Treatments
FDA

Novo Targets FDA Filing for Etavopivat After 27% VOC Reduction

Novo Targets FDA Filing for Etavopivat After 27% VOC Reduction
FDA

RevMed Doubles Phase 3 Survival With Pan-RAS Drug at AACR25

RevMed Doubles Phase 3 Survival With Pan-RAS Drug at AACR25
FDA

Merck Hits 55% NSCLC ORR With MK-2010, Won't Commit to Phase 3

Merck Hits 55% NSCLC ORR With MK-2010, Won't Commit to Phase 3
FDA

Rejected Twice: Replimune's RP1 and the 22 Scientists Who Disagreed

Rejected Twice: Replimune's RP1 and the 22 Scientists Who Disagreed
FDA

Recalled: Viatris Xanax Lot, Teva's 7 Clonidine Batches

Recalled: Viatris Xanax Lot, Teva's 7 Clonidine Batches
Deals

Aligos Sells China HBV Rights to Amoytop in $445M Deal

Aligos Sells China HBV Rights to Amoytop in $445M Deal
Deals

Revolution Doubles Offering to $2B at $142 After Daraxonrasib Phase 3 Win

Revolution Doubles Offering to $2B at $142 After Daraxonrasib Phase 3 Win
FDA

FDA Cleared Foundayo With 3 Postmarketing Safety Study Requirements

FDA Cleared Foundayo With 3 Postmarketing Safety Study Requirements
FDA

FDA Cleared Filspari for FSGS; Travere Eyes $3B U.S. Peak

FDA Cleared Filspari for FSGS; Travere Eyes $3B U.S. Peak
FDA

Doubles PDAC Survival: Revolution Jumps 40% on Daraxonrasib Phase 3 Data

Doubles PDAC Survival: Revolution Jumps 40% on Daraxonrasib Phase 3 Data
FDA

FDA Cleared Filspari for FSGS Despite Phase 3 Fail, Opening $2B Market

FDA Cleared Filspari for FSGS Despite Phase 3 Fail, Opening $2B Market
FDA

IDEAYA Files FDA: Darovasertib Doubles PFS to 6.9 Months

IDEAYA Files FDA: Darovasertib Doubles PFS to 6.9 Months
FDA

Ideaya Eye Cancer Drug Hits Phase 3, Files Accelerated NDA

Ideaya Eye Cancer Drug Hits Phase 3, Files Accelerated NDA
FDA

Beats Venetoclax: Lilly's Jaypirca Posts 4th Phase 3 Win in CLL

Beats Venetoclax: Lilly's Jaypirca Posts 4th Phase 3 Win in CLL
FDA

Cleared Phase 3: Daraxonrasib Hits 13.2-Month OS in Pancreatic Cancer

Cleared Phase 3: Daraxonrasib Hits 13.2-Month OS in Pancreatic Cancer
FDA

Darovasertib Hits 6.9-Month PFS Goal, Ideaya Plans H2 FDA Filing

Darovasertib Hits 6.9-Month PFS Goal, Ideaya Plans H2 FDA Filing
FDA

FDA Cleared Foundayo; Lilly Pre-Stocked $1.5B Before Approval

FDA Cleared Foundayo; Lilly Pre-Stocked $1.5B Before Approval
Deals

BARDA Cut $482m Shionogi Deal for US Antibiotic Capacity

BARDA Cut $482m Shionogi Deal for US Antibiotic Capacity
FDA

FDA Sets First Formal Rules for Form 483 Responses

FDA Sets First Formal Rules for Form 483 Responses
Deals

Gilead Spends $14.77B on Three Deals, Then Hits Pause

Gilead Spends $14.77B on Three Deals, Then Hits Pause
FDA

Lilly Foundayo Clears FDA; Novo's Oral Holds 5-Point Lead

Lilly Foundayo Clears FDA; Novo's Oral Holds 5-Point Lead
FDA

Amgen's Tepezza Just Got Injectable Data. So Did Viridian.

Amgen's Tepezza Just Got Injectable Data. So Did Viridian.
FDA

FDA Asks Congress for Market Withdrawal Power Over Manufacturing Gaps

FDA Asks Congress for Market Withdrawal Power Over Manufacturing Gaps
Deals

Apnimed Locks $150M Credit Line for AD109 Sleep Apnea Launch

Apnimed Locks $150M Credit Line for AD109 Sleep Apnea Launch
FDA

ImmunityBio Loses $2B in a Day After FDA Hits 'Cures Cancer' Pitch

ImmunityBio Loses $2B in a Day After FDA Hits 'Cures Cancer' Pitch
Deals

Lilly Pays $7.8B for Centessa to Buy Into the Orexin Race

FDA

Makary's FDA Gets White House Backing to Fast-Track US Biotech vs. China

Makary's FDA Gets White House Backing to Fast-Track US Biotech vs. China
Deals

Anthropic Drops $400M on Six-Person Drug Discovery Startup

Anthropic Drops $400M on Six-Person Drug Discovery Startup
Deals

Takeda Walks Away From $150M Denali Dementia Bet After 8 Years

Takeda Walks Away From $150M Denali Dementia Bet After 8 Years
Deals

Neurocrine Pays $2.9B for Soleno's Prader-Willi Drug

Neurocrine Pays $2.9B for Soleno's Prader-Willi Drug
FDA

Lipocine's PPD Drug Fails Phase 3, Stock Craters 77%

Lipocine's PPD Drug Fails Phase 3, Stock Craters 77%
FDA

Novo Fires Back at Lilly's Foundayo With Competing Efficacy Data

Novo Fires Back at Lilly's Foundayo With Competing Efficacy Data
FDA

Pfizer Scraps COVID Vaccine Trial; 80% of Recruits Failed Screening

Pfizer Scraps COVID Vaccine Trial; 80% of Recruits Failed Screening
FDA

FDA Clears Novocure's Pancreatic Cancer Device in First-Ever Approval

FDA Clears Novocure's Pancreatic Cancer Device in First-Ever Approval
FDA

FDA Clears 7.2mg Wegovy HD for Novo Nordisk in 54-Day Sprint

FDA

Lilly's Oral GLP-1 Pill Cleared in 50 Days, Fastest NME Since 2002

Lilly's Oral GLP-1 Pill Cleared in 50 Days, Fastest NME Since 2002