The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.

20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme.

The recent FDA approvals of two treatments for molluscum contagiosum may represent a shift in how clinicians view this disease, according to a speaker at Masters of Pediatric Dermatology.In an ...

Investigative therapies to treat moderate to severe plaque psoriasis in clinical trials include several orally administered ...

Genzyme became a subsidiary of Sanofi and kept ... Biggest Boston biotech news coming out of JPM 2025 Hologic gets FDA warning regarding implantable devices Hologic gets FDA warning regarding ...

The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan ...

THURSDAY, Jan. 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has warned ... for active pharmaceutical ingredients at their Genzyme manufacturing plant in Framingham ...

The drug, IONIS-AZ5-2.5RX ... Developed in partnership with Sanofi's Genzyme unit, patisiran is currently under review in the US and EU. If approved Alnylam will market patisiran in the US ...

After winning approval in the United States back in September, Sanofi Genzyme’s multiple sclerosis drug, aubagio, has won approval for use in Australia. The Australian Therapeutic Goods ...