The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. with Xolair since its initial approval in 2003. with Xolair since its initial approval in 2003.

FDA Approval 52

FDA Approval Clinical Development FDA Licensing 52

New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. New Haven, CT. and > 300 mg/mL at lower pH pKa 4.8

Clinical Trials 40

Clinical Trials Treatment FDA Trials 40

FDA Law Blog: Biosimilars

JANUARY 9, 2024

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires. See 21 C.F.R. 251.5; § 251.6(c).

FDA Approval 59

FDA Approval FDA Drugs Compliance 59

Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. 644 (2003), but not to Pike. Other state laws affecting FDA-approved drugs are more likely to have the required protectionist bent.

Regulations 59

Regulations Production FDA FDA Approval 59

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. In Bruesewitz v. Wyeth LLC , 562 U.S. at 237-38. Wyeth Laboratories, Inc. , 2d 397 (6th Cir. 2d at 401.

FDA 59

FDA FDA Approval Testimonials Vaccine 59