FiercePharma5h
Pfizer's Braftovi combo on track for full approval in win for FDA's Project FrontRunner
Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...
JD Supra4d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
HCW Biologics Granted FDA Clearance to Evaluate One of the Company’s Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial
Wong, Founder and CEO of HCW Biologics, commented, “The FDA’s clearance to initiate our first-in-human clinical trial for HCW9302 brings us one step closer to advancing a potentially transformative ...
BioSpace11d
FDA Tacks Boxed Warning on Teva’s Copaxone, Other MS Drugs
The drugs’ active ingredient, glatiramer acetate, has been linked to more than 80 cases of anaphylaxis worldwide since ...
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...
FDA approves HCW Biologics trial for alopecia treatment
MIRAMAR, Fla. - HCW Biologics Inc. (NASDAQ: HCWB), a clinical-stage biopharmaceutical company with a market capitalization of approximately $12.4 million, announced today that it has received U.S.
GlobalData on MSN11d
FDA grants ODD status to Zai Lab’s lung cancer treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Zai Lab’s delta-like ligand 3 (DLL3) antibody-drug conjugate (ADC), ZL-1310, for small cell lung cancer (SCLC).
Day One Biopharmaceuticals: A Successful Launch In Pediatric Cancer
Day One Biopharma's OJEMDA FDA approval for pediatric glioma, but market concerns remain. Check out why I rate DAWN stock as ...