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Drug Approvals

All articles tagged with #drug approvals

health1 day ago•1 min saved

FDA resumes posting drug rejection letters, underscoring transparency push

The FDA posted 14 new complete response letters (CRLs) for drug applications after a three-month pause on real-time CRL disclosure. Highlights include Grace Therapeutics’ nimodipine injectable for aneurysmal subarachnoid hemorrhage and a third anti-PD-1/VEGFR combo rejection by Hengrui/Elevar. The pause followed a citizen petition, with the disclosure policy tied to a broader transparency effort championed by Health Secretary Kennedy Jr. and former FDA Commissioner Makary. Earlier waves of CRLs and ongoing efforts to formalize disclosure—including proposed rule changes and potential FD&C Act amendments—have framed the push for real-time CRL release.

via Fierce Biotech|

#complete-response-letters #drug-approvals #fda

health-policy4 months ago•2 min saved

FDA advisory panels retreat from public scrutiny as controversial drug decisions mount

Advisory panels are playing a smaller public role as drug regulatory decisions grow more contentious, with a Trump-era private briefing in which an FDA official anonymously criticized UniQure’s Huntington’s disease therapy illustrating a shift toward nonpublic decision-making and sparking calls for greater transparency from patients and clinicians.

via statnews.com|

#advisory-committees #drug-approvals #fda

health-policy4 months ago•2 min saved

The price tag on the FDA’s aggressive regulatory push

An opinion piece argues that FDA leaders Peter Marks and Vinay Prasad have pursued a rigorous, aggressive regulatory approach that comes with costs for biotech firms and patients, fueling debate over approving drugs with uncertain benefits.

via statnews.com|

#biotech-policy #drug-approvals #fda

health4 months ago•182 min saved

FDA faces sharp questions as criticism grows over new drug decisions

An FDA official held a rare press call to defend the agency’s decision to require an additional clinical trial for UniQure’s Huntington’s disease gene therapy, criticizing outside scientists and signaling concerns about potential conflicts of interest. The exchange follows ongoing uproar over the agency’s handling of drug approvals, including Moderna’s flu vaccine application, and underscores a tension between expanding rapid approvals and ensuring solid evidence through placebo-controlled trials in order to prevent unsafe or ineffective medicines.

via CNN|

#drug-approvals #fda #health

health4 months ago•14 min saved

FDA pitches faster path to rare-disease therapies

The FDA, led by Dr. Marty Makary in a White House event with President Trump, proposed a new framework to speed approvals for therapies targeting rare diseases.

via AP News|

#drug-approvals #fda #health

health4 months ago•2 min saved

One-pivotal-trial rule aims to redefine drug approvals

FDA officials say a single pivotal trial will be the default standard for drug approvals, a policy shift outlined in an NEJM perspective by Marty Makary and Vinay Prasad.

via Endpoints News|

#drug-approvals #fda #health

health4 months ago•15 min saved

One-Study Path to FDA Drug Approvals Sparks Policy Debate

FDA Commissioner Marty Makary and Prasad argue that a single pivotal study could suffice for drug approvals, a shift aimed at speeding access but drawing concerns about the robustness of evidence and patient safety.

via Associated Press News|

#drug-approvals #fda #health

health5 months ago•50 min saved

FDA’s Fast-Track Drug Vouchers Spark Sign-Off Scrutiny

AP reports that FDA Commissioner Marty Makary’s voucher-based effort to accelerate drug approvals into a one-month window has stirred alarm inside the agency. Questions swirl over who has legal authority to sign off on these expedited approvals, with senior officials and political appointees increasingly involved in the process, diverging from the traditional scientist-led review. The program, not codified in federal rules and now expanded to 18 vouchers, has coincided with staff layoffs and leadership turnover, fueling concerns about politicization, safety standards, and potential legal risk for the agency as critics warn that such rapid reviews lack scientific precedent.

via Yahoo|

#drug-approvals #fda #health

health8 months ago•3 min saved

FDA Disarray Sparks Staff Concerns and Credibility Issues

The FDA is experiencing significant turmoil with high-profile staff departures, leadership resignations, and internal mistrust, raising concerns about its reliability and impact on drug approvals and public health, amid broader government downsizing and political pressures.

via Axios|

#agency-turmoil #drug-approvals #fda

healthcare2 years ago•10 min saved

"2023's Remarkable Medical Breakthroughs: Drug Approvals, Vaccines, and Innovations"

GoodRx Health has compiled a list of the most notable drug and vaccine approvals of 2023, selected by pharmacists. The list includes Paxlovid for COVID-19, Arexvy, Abrysvo, and Beyfortus for RSV, Opill for contraception, Zurzuvae for postpartum depression, Leqembi for Alzheimer's disease, OTC naloxone for opioid overdoses, Zepbound for chronic weight management, Roctavian for hemophilia A, and Casgevy and Lyfgenia for sickle cell disease. These approvals are seen as meaningful steps forward in improving human health and accessibility to treatments.

via Fox News|

#drug-approvals #fda #healthcare

business3 years ago•7 min saved

"Pfizer's Hidden Potential: Uncovering the Undervalued Gem on NYSE"

Pfizer's financial position is expected to benefit from recent events, including multiple drug and vaccine approvals, which will help offset potential revenue losses from exclusivity and reduced demand for the COVID-19 vaccine. The company's experimental drug, danuglipron, is poised to compete with leaders in the diabetes treatment market. Additionally, the FDA approval of Abrysvo for respiratory syncytial virus in older people opens up significant commercial opportunities. The recent FDA approvals of Litfulo and Ngenla further strengthen Pfizer's position in the pharmaceutical industry. Ngenla's entry into the US market is expected to drive strong sales growth and profit generation. With extensive long-term data and market recognition, Pfizer aims to regain its share of the global human growth hormone market. Despite a recent decrease in share price, technical analysis suggests a potential reversal upwards. The article concludes with an "outperform" rating for Pfizer.

via Seeking Alpha|

#business #drug-approvals #growth-hormone-deficiency

healthcare3 years ago•2 min saved

Controversy Surrounds Abortion Pill Decision and FDA Support

Pfizer CEO Albert Bourla signed a letter along with over 200 pharmaceutical company executives in support of the FDA's authority to regulate drugs after a federal judge in Texas suspended the agency's approval of the abortion pill mifepristone. The executives raised concerns that the ruling will set a precedent for diminishing the FDA's authority over drug approvals, which would create uncertainty for the entire industry. The dueling orders by two federal judges create a complicated legal standoff that could potentially escalate to the Supreme Court.

via CNBC|

#abortion-pill #drug-approvals #fda