Tag

Drug Approval

All articles tagged with #drug approval

business1 month ago•5 min saved

Biotech investors wary as FDA shifts stance on rare-disease drugs

Over the past year the FDA has denied or discouraged at least eight drug applications, including UniQure’s Huntington’s gene therapy and Regenxbio’s Hunter syndrome, and even reversed course on Moderna’s flu vaccine review, prompting investors to doubt whether the agency’s rare-disease flexibility will endure and to worry about the fate of other pipeline drugs; upcoming decisions (e.g., Denali Therapeutics) will test whether current standards remain consistent amid broader regulatory uncertainty.

via CNBC|

#biotech #business #drug-approval

healthcare1 month ago•2 min saved

FDA reversal sinks rare-disease cell therapy after favorable reviews

An experimental cell therapy for a rare post-transplant blood cancer, developed by Atara Biotherapeutics and Pierre Fabre, was on track for FDA approval after internal reviewers recommended clearance, but the agency unexpectedly rejected it last month, citing deficient clinical data. Anonymous former agency sources say the decision may reflect leadership changes, marking a sharp reversal that disrupts a treatment expected to help roughly 500 patients in the US each year with a grim prognosis.

via statnews.com|

#biotech #drug-approval #fda

health2 months ago•8 min saved

FDA's Fast-Track Drug Voucher Faces Legal and Safety Scrutiny

The FDA's National Priority Voucher program aims to speed drug approvals, but critics warn it bypasses standard scientific and regulatory safeguards, raising concerns about who signs off on decisions and whether political pressure is affecting timelines amid staff upheaval and safety worries.

via PBS|

#drug-approval #expedited-review #fda

health5 months ago•1 min saved

FDA turmoil continues as leaders resign and face legal challenges

The FDA is embroiled in controversy following allegations against top regulator Tidmarsh, who criticized Aurinia's lupus drug voclosporin, leading to his resignation and concerns over the agency's credibility amid claims of misconduct and mismanagement.

via Ars Technica|

#aurinia #drug-approval #fda

health5 months ago•1 min saved

FDA Drug Chief Resigns Amid Ethics and Lawsuit Controversies

George Tidmarsh, head of the FDA's Center for Drug Evaluation and Research, resigned amid ethics concerns and a lawsuit alleging bribery and false statements, following his administrative leave after raising issues about a drug approval program and questioning a drug's safety.

via Reuters|

#drug-approval #ethics #fda

health5 months ago•3 min saved

FDA awards 9 companies priority review vouchers for expedited drug approvals

The FDA has issued its first nine priority review vouchers to expedite the approval process for certain drugs and therapies, including Regeneron's gene therapy for hearing loss, with the aim of reducing approval times from 10-12 months to 1-2 months, focusing on public health priorities and affordability.

via Fierce Biotech|

#drug-approval #fda #gene-therapy

health5 months ago•0 min saved

FDA Grants First Priority Review Vouchers to Nine Drugs

The FDA announced the first nine recipients of the Commissioner’s National Priority Review vouchers, which expedite drug reviews for products aligned with national health priorities. Notably, EMD Serono received a voucher after agreeing to lower prices for its fertility drugs, including Pergoveris, in a move highlighted by President Trump. The program aims to incentivize companies to develop and provide access to important medications.

via statnews.com|

#drug-approval #emd-serono #fda

politics6 months ago•0 min saved

FDA Approves Multiple Generic Abortion Pills Amid Political Tensions

The Trump administration approved a new generic version of the abortion pill mifepristone, sparking outrage among abortion opponents who criticize the administration's handling of drug approvals.

via The Washington Post|

#abortion #drug-approval #mifepristone

health6 months ago•1 min saved

FDA Approves New Autism Treatment Amid Policy Changes

The FDA unexpectedly approved the old chemotherapy drug leucovorin as a treatment for some individuals with autism, deviating from its usual rigorous review process, which has raised concerns among experts about the potential for hype and the narrowing of the drug's scope.

via The New York Times|

#autism #drug-approval #fda

health7 months ago•7 min saved

FDA's Shift Away from Expert Reviews Sparks Industry Concerns

Under the Trump administration, the FDA is moving to phase out the practice of consulting outside experts for drug reviews, citing efficiency, but critics argue this reduces transparency and public oversight, potentially impacting the rigor and accountability of drug approval processes.

via CNN|

#drug-approval #expert-reviews #fda

health7 months ago•7 min saved

FDA Under Trump Moves Away from Expert Drug Reviews

Under the Trump administration, the FDA is moving to eliminate the practice of consulting outside experts for drug reviews, arguing it saves time and resources, but critics say it reduces transparency and public trust in drug approval decisions. The agency plans to rely more on complete response letters and internal reviews, sparking concerns about the loss of public and expert input in the regulatory process.

via KFF Health News|

#drug-approval #expert-reviews #fda

health7 months ago•2 min saved

AstraZeneca and Baxdrostat unveil promising new treatments for resistant hypertension

AstraZeneca plans to seek regulatory approval for its experimental blood pressure drug, baxdrostat, by the end of the year, aiming for potential approval in 2026 in the US and EU. The drug targets the hormone aldosterone and has shown promising results in reducing systolic blood pressure, with peak sales expected to exceed $5 billion. A small percentage of patients experienced hyperkalaemia.

via Reuters|

#astrazeneca #baxdrostat #blood-pressure

business7 months ago•2 min saved

Eli Lilly's Weight Loss Pill Nears Approval After Successful Trials

Eli Lilly is preparing for the potential approval of a new weight loss pill following successful late-stage clinical trials, signaling a significant development in the pharmaceutical company's product pipeline.

via TipRanks|

#business #clinical-trial #drug-approval

business8 months ago•2 min saved

FDA Turmoil Deepens as Top Vaccine Regulator Vinay Prasad Returns, Impacting Biotech Stocks

Biotech shares experienced volatility following the surprise reinstatement of FDA official Vinay Prasad, whose return raises concerns about political influence affecting drug approval processes amid leadership turmoil within the FDA, impacting companies like Sarepta and Replimune.

via Financial Times|

#biotech-stocks #business #drug-approval

world8 months ago•1 min saved

FDA Top Vaccine Regulator Reinstated Amid Turmoil

The FDA is currently facing turmoil after approving Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy in 2023, which was later linked to three patient deaths from liver failure, leading to a suspension request and a sharp decline in Sarepta's stock value.

via The Economist|

#drug-approval #duchenne-muscular-dystrophy #fda