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FDA Warns New Life Pharma Over Inspection Refusal and Manufacturing Violations

FDA Warns New Life Pharma Over Inspection Refusal and Manufacturing Violations

The FDA has issued a warning letter to New Life Pharma after the company refused inspectors access to parts of its GLP-1 manufacturing facility in New Jersey. The inspection, conducted in February, revealed that New Life was producing semaglutide and tirzepatide vials without proper procedures to prevent microbiological contamination. The FDA found multiple compliance failures with current good manufacturing practices (CGMP) and noted that the company's quality control unit failed to ensure the sterility of drug products. New Life's refusal to allow access to certain facility areas violated FDA inspection rules. The company has since agreed to halt drug production at the facility but indicated plans to resume after addressing sterility issues.
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Adial Pharmaceuticals Advances AD04 for Alcohol Use Disorder with Successful Manufacturing Step

Adial Pharmaceuticals Advances AD04 for Alcohol Use Disorder with Successful Manufacturing Step

Adial Pharmaceuticals Advances AD04 for Alcohol Use Disorder with Successful Manufacturing Step
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4Moving Biotech Receives FDA Fast Track Designation for Knee Osteoarthritis Drug

4Moving Biotech Receives FDA Fast Track Designation for Knee Osteoarthritis Drug

4Moving Biotech Receives FDA Fast Track Designation for Knee Osteoarthritis Drug
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Immunome to Present Phase 3 RINGSIDE Trial Data at ASCO 2026

Immunome to Present Phase 3 RINGSIDE Trial Data at ASCO 2026

Immunome, Inc. will present data from its Phase 3 RINGSIDE trial at the 2026 ASCO Annual Meeting. The trial evaluated varegacestat, a gamma secretase inhibitor, in patients with progressing desmoid tumors. The study, which is the largest of its kind, assessed progression-free survival and other secondary endpoints such as tumor volume reduction and pain intensity. Positive topline results were reported in December 2025, and Immunome plans to submit a New Drug Application to the FDA in Q2 2026.
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FDA Extends Review of Sanofi's Subcutaneous Sarclisa, Delaying Decision

FDA Extends Review of Sanofi's Subcutaneous Sarclisa, Delaying Decision

FDA Extends Review of Sanofi's Subcutaneous Sarclisa, Delaying Decision
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AAN 2026: New Data from J, Kyverna, Capricor, and Praxis Could Transform Neurological Treatments

AAN 2026: New Data from J, Kyverna, Capricor, and Praxis Could Transform Neurological Treatments

AAN 2026: New Data from J, Kyverna, Capricor, and Praxis Could Transform Neurological Treatments
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FDA Approves Merck's IDVYNSO for HIV Treatment

FDA Approves Merck's IDVYNSO for HIV Treatment

The U.S. Food and Drug Administration (FDA) has approved Merck's IDVYNSO, a once-daily, two-drug regimen for the treatment of HIV-1 in adults. IDVYNSO combines doravirine and islatravir and is designed for patients who are virologically suppressed with no history of treatment failure. This approval marks the first non-INSTI, tenofovir-free regimen to demonstrate non-inferior efficacy compared to a three-drug regimen in a Phase 3 trial. IDVYNSO will be available in pharmacies starting May 11, offering a new treatment option for people living with HIV.
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Viatris Recalls Xanax XR Due to Dissolution Test Failure, Affecting U.S. Market

Viatris Recalls Xanax XR Due to Dissolution Test Failure, Affecting U.S. Market

Viatris Recalls Xanax XR Due to Dissolution Test Failure, Affecting U.S. Market
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Viatris Recalls Extended-Release Xanax Due to Dissolution Test Failure

Viatris Recalls Extended-Release Xanax Due to Dissolution Test Failure

Viatris Recalls Extended-Release Xanax Due to Dissolution Test Failure
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Wedding Industry Sees Rise in GLP-1 Use for Pre-Wedding Weight Loss

Wedding Industry Sees Rise in GLP-1 Use for Pre-Wedding Weight Loss

Wedding Industry Sees Rise in GLP-1 Use for Pre-Wedding Weight Loss
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GLP-1 boom nudges cannabis dispensaries to rethink offerings

GLP-1 boom nudges cannabis dispensaries to rethink offerings

By Mrinalika Roy and Sriparna Roy April 20 (Reuters) - The surging popularity of GLP-1 weight-loss drugs is quietly reshaping the $40 billion U.S. cannabis market, experts and industry executives said, as retailers adjust product offerings to suit changing consumer behavior tied to the therapies.
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MSD and Eisai Face Setback in Kidney Cancer Trial with Welireg

MSD and Eisai Face Setback in Kidney Cancer Trial with Welireg

MSD and Eisai Face Setback in Kidney Cancer Trial with Welireg