New FDA Rules for TV Drug Ads: Simpler Language and No Distractions
FDA's new rules aim to make drug ads clearer and more transparent, addressing long-standing concerns about risk information ...
Trump Chooses Anti-Vaccine Activist Robert F. Kennedy Jr. As Health Secretary
President-elect Trump expected to nominate anti-vaccine activist Robert F. Kennedy Jr as head of the Department of Health and ...
News Medical2d
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions.
Business Insider4d
Unicycive Says FDA Accepts NDA For Oxylanthanum Carbonate To Treat Patients With CKD On Dialysis
(RTTNews) - Biotechnology company Unicycive Therapeutics, Inc. (UNCY) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum ...
Business Insider2d
ClearPoint Neuro announces SmartFlow Neuro Cannula FDA authorization
ClearPoint Neuro (CLPT) “announced the U.S. Food and Drug Administration has granted marketing authorization for the SmartFlow Neuro Cannula using the De Novo pathway. The SmartFlow Neuro ...
GSK Raises Prospects For Withdrawn Blood Cancer Drug Blenrep To Return To US Market - Here's Why
In June, GSK released results from an interim analysis of the DREAMM-8 phase 3 head-to-head trial of Blenrep in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, ...
European committee takes a second look at Alzheimer's drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting the drug.
The Vancouver Sun2d
Mounties make arrests, seize firearms, drugs from Mexico cartel-linked Surrey group
The RCMP has arrested three suspected cocaine smugglers who are part of a criminal organization linked to Mexican cartels.
Food Safety News2d
Patient count in McDonald’s E. coli outbreak tops 100; FDA continues investigation
The patient count now stands at 104. The Food and Drug Administration and the Centers for Disease Control and Prevention are continuing to investigate the outbreak. Of 98 patients interviewed ...
‘Anti-Woke’ 1789 Capital Bets on Drug Startup BlinkRx
Led by Malik, a donor to President-elect Donald Trump, 1789 Capital has eschewed environmental, social and governance, or ESG, investing principles amid a conservative backlash to “woke” financing ...
Merck signs up to $3.3 billion cancer drug deal with China-based LaNova
(Reuters) -Merck has signed a licensing agreement worth up to $3.3 billion with Shanghai-based LaNova Medicines to develop, make and sell an experimental cancer drug, the two companies said on ...
Bristol Myers faces renewed, $6.7 billion lawsuit over delayed cancer drug
Bristol Myers Squibb was hit on Thursday with a $6.7 billion lawsuit claiming it cheated former Celgene shareholders by delaying federal approval for three drugs, 1-1/2 months after a federal judge ...