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FDA Approval

Drug Approval Process Medical Devices Biologics License Application New Drug Application Drug Development Diagnostic Tests Drug Review Process Drug Safety Accelerated Approval Priority Review

3 ARTICLES

yesterday

FDA Approves Lisraya for Adult Dermatomyositis

The decision clears a new targeted JAK/TYK2 oral pill after a 52-week trial showed measurable clinical benefit and less steroid use for some patients.

6 ARTICLES

last wk.

Aficamten Improves Symptoms and Exercise Capacity in Nonobstructive HCM

7 ARTICLES

2w ago

FDA Clears Roche and Eli Lilly Blood Test to Help Assess Alzheimer’s-Linked Brain Changes

3 ARTICLES

2w ago

FDA Clears Mass‑Spec Blood Test to Detect Alzheimer’s Amyloid

6 ARTICLES

2w ago

FDA Grants Accelerated Approval to Genglycos for Glycogen Storage Disease Type Ia

3 ARTICLES

2w ago

FDA Clears Aletta Robot to Autonomously Draw Blood in Outpatient Adults

4 ARTICLES

4w ago

Tenax Therapeutics Stock Collapses After Phase 3 Levosimendan Trial Misses Endpoints

46 ARTICLES

4w ago

FDA Approves Moderna’s mFlusiva for Adults 50 and Older

6 ARTICLES

4w ago

FDA Approves Orzeyful as First Orexin Agonist for Narcolepsy Type 1

4 ARTICLES

last mo.

Large U.S. Trial Finds Silver Diamine Fluoride Stops Many Cavities in Young Children

6 ARTICLES

last mo.

FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

5 ARTICLES

2mo ago

FDA Accepts Roche’s Tecentriq for Priority Review in dMMR Stage III Colon Cancer

7 ARTICLES

3mo ago

New Oral Drug Nearly Doubles Survival for Treated Metastatic Pancreatic Cancer

FDA Approval

FDA Approves Lisraya for Adult Dermatomyositis

Aficamten Improves Symptoms and Exercise Capacity in Nonobstructive HCM

FDA Clears Roche and Eli Lilly Blood Test to Help Assess Alzheimer’s-Linked Brain Changes

FDA Clears Mass‑Spec Blood Test to Detect Alzheimer’s Amyloid

FDA Grants Accelerated Approval to Genglycos for Glycogen Storage Disease Type Ia

FDA Clears Aletta Robot to Autonomously Draw Blood in Outpatient Adults

Tenax Therapeutics Stock Collapses After Phase 3 Levosimendan Trial Misses Endpoints

FDA Approves Moderna’s mFlusiva for Adults 50 and Older

FDA Approves Orzeyful as First Orexin Agonist for Narcolepsy Type 1

Large U.S. Trial Finds Silver Diamine Fluoride Stops Many Cavities in Young Children

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FDA Approval

Large U.S. Trial Shows Liquid Treatment Halts Decay in Over Half of Baby Teeth

FDA Licenses First U.S. Freeze-Dried Plasma, Ezplaz

FDA Approves First Oral PCSK9 Pill, Merck’s Lipfendra

AstraZeneca Licenses Global Rights to Zegfrovy From Dizal

FDA Approves At‑Home Weekly Subcutaneous Starter Dose for Leqembi

FDA Grants Priority Review to Roche’s Enspryng for Thyroid Eye Disease

FDA Approves Lumvoa for Thyroid Eye Disease

FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

FDA Accepts Roche’s Tecentriq for Priority Review in dMMR Stage III Colon Cancer

New Oral Drug Nearly Doubles Survival for Treated Metastatic Pancreatic Cancer

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FDA Approval