Vertex Pharmaceuticals Gets a Huge FDA Approval Which Could Send the Stock Skyrocketing
Obtaining approval from the U.S. Food and Drug Administration (FDA) for a key medication can be a huge catalyst for a ...
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FDA Drug Approval Decisions Expected in March 2025
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for ...
US FDA approves SpringWorks' genetic disorder drug
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...
First nonopioid painkiller in 25 years approved by FDA, offering new hope for patients
A newly approved pain medication, suzetrigine, is the first nonopioid analgesic in 25 years to receive clearance from the U.S. Food and Drug Administration, a breakthrough that has excited pain ...
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FDA approves Ono's rare tumor drug from $2.4B Deciphera buyout
A new FDA approval stands to give Daiichi Sankyo’s Turalio some company in a rare tumor type. | The new FDA approval gives ...
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FDA Alert: Pulmonology Drug Approvals, Recalls, and Device Updates
FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.
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FDA approves Evrysdi tablets for spinal muscular atrophy
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
Vertex Pharma Just Scored a Major FDA Approval. Is the Stock a No-Brainer Buy Now?
Vertex Pharmaceuticals ( VRTX 2.53%) has long been known as the company to turn to for life-saving cystic fibrosis (CF) drugs ...
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLIâ„¢ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
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AbbVie Gets FDA Approval for New Antibiotic in the Face of Rising Resistance
The intravenous antibiotic Emblaveo, a combination of aztreonam and avibactam approved in Europe last year, was developed in ...
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New Tablet Formulation of SMA Therapy Evrysdi Gets FDA Approval
The tablet formulation can either be swallowed whole or dispersed in a teaspoon of filtered (non-chlorinated) water.
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...