FDA Archives - Spark Newswire

2 minute read

PTC Therapeutics Says FDA Lifts Clinical Hold On Investigational Study In Patients With Rare Weak Nerve Cell Disorder

June 20, 10:09 AM

PTC Therapeutics released interim results from its Phase 2 PIVOT-HD study on PTC518 for Huntington's disease. The FDA has lifted the partial clinical hold on the program.

PTCT

2 minute read

What Is The Trump Factor? Justice Dept’s Impact On Cannabis Rescheduling, Stocks And Investments

By Nicolas Jose Rodriguez

June 18, 5:03 PM

Equity research firm Zuanic & Associates convened a panel in mid-June featuring industry experts to dissect the ongoing cannabis rescheduling efforts in the US. They provided a comprehensive outlook on the rescheduling process, expected to conclude with the publication of the Final Rule in the Federal Register by November 2024.

CRLBF

1 minute read

Why Is Small-Cap Cancer-Focused Zentalis Pharma Stock Trading Lower On Tuesday?

By Vandana Singh

June 18, 8:44 AM

Zentalis Pharmaceuticals announced the FDA's partial clinical hold on azenosertib studies due to recent patient deaths.

ZNTL

2 minute read

FDA Approves Merck’s Pneumococcal Vaccine As First Shot Designed For Adults

By Vandana Singh

June 18, 8:05 AM

The FDA has approved Merck's Capvaxive, the first pneumococcal conjugate vaccine for adults, protecting against 21 strains of bacteria. Additionally, Merck's Keytruda received FDA approval for advanced endometrial carcinoma.

MRK

1 minute read

Why Is Pfizer Partner BioNTech Stock Trading Lower On Monday?

By Vandana Singh

June 17, 1:22 PM

BioNTech partner MediLink Therapeutics faces a partial clinical hold from the FDA on the Phase 1 trial of BNT326/YL202 for advanced non-small cell lung cancer and HR+/HER2-negative breast cancer.

BNTX

1 minute read

Philips Zenition 90 Motorized Receives FDA 510(k) Clearance To Help Clinicians Deliver High Quality Care With A High-Powered And Fast Motorized Mobile C-Arm

By Benzinga Newsdesk

June 17, 9:05 AM

Intuitive motorization for greater control and high-power (25 kW [1]) for state-of-the-art image quality supports complex vascular needs and a full range of clinical proceduresAutomated workflows contribute to greater

PHG

1 minute read

FDA
News

Scilex Holding Announces Publication Of Trial Results For SP-102 (SEMDEXA) In PAIN Journal; Focuses On Non-Opioid Pain Management Products For Acute And Chronic Pain

By Benzinga Newsdesk

June 14, 1:43 PM

The Phase 3 study results are being published in PAIN® Journal, which is the leading journal devoted to pain medicine and research. PAIN is the official journal of the International Association for the Study of

SCLX

1 minute read

Ultragenyx Plans To File For Accelerated Approval Of UX111 For The Treatment Of Sanfilippo Syndrome Type A, After Meeting With FDA

By Benzinga Newsdesk

June 12, 4:00 PM

Agreement reached with FDA that cerebral spinal fluid (CSF) heparan sulfate (HS) can be used as a reasonable surrogate endpoint for accelerated approval Data from existing clinical studies appear sufficient for a

RARE

2 minute read

Reported Monday June 10, 2024 “Amneal, U.S. FTC Win Order Removing Teva Inhaler Patents From FDA List” – Reuters News

By Benzinga Newsdesk

June 11, 10:40 AM

https://www.reuters.com/legal/litigation/amneal-us-ftc-win-order-removing-teva-inhaler-patents-fda-list-2024-06-10/ Drugmaker Amneal Pharmaceuticals (AMRX.O), opens new tab with the backing of the U.S. Federal Trade

AMRX

1 minute read

FDA
News

60 Degrees Pharmaceuticals Announces FDA Orphan Drug Designation For Tafenoquine To Treat Acute Babesiosis

By Benzinga Newsdesk

June 11, 8:00 AM

With the tafenoquine for acute babesiosis orphan drug designation, 60 Degrees Pharmaceuticals now qualifies for certain incentives, including market exclusivity, tax credits, and exemption from certain FDA filing fees.60

SXTP