FDA Approvals

The US Food and Drug Administration (FDA) recently announced that fixed-combination drugs (FCD) comprised of at least one NCE will be eligible for five...

Novartis’s Jadenu receives FDA approval to treat chronic iron overload

Americas

Novartis has received approval from the US Food and Drug Administration (FDA) for its Jadenu (deferasirox) tablets to treat patients with chronic iron overload....

GSK’s Breo for asthma? FDA panel says yes–but only in adults

FDA Approvals

Good news for GlaxoSmithKline ($GSK): An FDA panel of experts says the efficacy and safety data for blockbuster wannabeBreo support the asthma indication it's...

Takeda and Orexigen receive FDA approval for new weight-loss pill called Contrave

Americas

Takeda Pharmaceuticals USA and Orexigen Therapeutics have received approval from the US Food and Drug Administration (FDA) for a new weight-loss pill...

Takeda and Orexigen Announce FDA Approval of Contrave ® (naltrexone HCI and bupropion HCI) Extended – release Tablets for Chronic Weight Management

Americas

Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. jointly announced today that the U.S. Food and Drug Administration (FDA) has approved Contrave® (naltrexone HCI...

Takeda and Lundbeck announce FDA approval of Brintellix™

FDA Approvals

H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited (Takeda) jointly announced that the U.S. Food and Drug Administration (FDA) has approved Brintellix™ (vortioxetine)...

FDA Approves Use of Menactra® Vaccine for Booster Immunization Against Potentially Deadly Disease

Americas

Sanofi Pasteur, the vaccines division of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) approved use of Menactra® for booster...

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