Healthy Returns: The FDA approved fewer new drugs in 2024 — but some big ones hit the market
The FDA wrapped up 2024 with 50 new drug approvals, clearing a wave of long-awaited treatments. Meanwhile, Transcarent will ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo (Dec. 27)
By Sneha S K and Sriparna Roy (Reuters) -The U.S. Food and Drug Administration said on Friday that it has approved an ...
C&EN1d
50 new drugs received FDA approval in 2024
The US Food and Drug Administration approved 50 new molecular entities in 2024 —just five fewer than it did in 2023. Last ...
19 drug approvals in 2024 that had 'big clinical impact,' according to GoodRx
GoodRx released a list of 19 of the most influential drugs and vaccines approved by the FDA in 2024 to treat a variety of ...
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FDA Announces Draft Guidance on Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial Is Underway
On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration ...
BioSpace2d
When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...
infectiousdiseaseadvisor.com18h
FDA Drug Approval Decisions Expected in February 2025
The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.
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FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024
The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...
Mersana Therapeutics Announces Additional FDA Fast Track Designation Granted to Emiltatug Ledadotin (XMT-1660)
Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of ...
The anxious wait for life-changing drug approval
In the UK, the drug has had approval by the MHRA, but is awaiting a decision by NICE, which is expected by August 2025. "If I ...
FDA To Decide On Agios' Request For Expanded Approval Of PYRUKYND In Thalassemia By September 7.
Agios Pharmaceuticals, Inc. (AGIO), on Wednesday, announced that its supplemental New Drug Application seeking approval for the ...
Everyday Health13d
FDA Approves First Medication for Obstructive Sleep Apnea
By aiding weight loss, Zepbound can improve symptoms of obstructive sleep apnea (OSA) in people with obesity — but CPAP ...