Friday, April 26, 2024

Friday, April 26, 2024

Latest News

ALLERGAN, PLC: FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity

FDA Approval

By Press release submission | Jun 21, 2019

Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental biologics application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity. BOTOX® was granted a six-month Priority Review by the FDA, which is typically granted to therapies that if approved, could offer significant improvements in safety and effectiveness when compared to current standard of care.

OCULAR THERAPEUTIX: Announces FDA Approval of Supplemental New Drug Application (sNDA) for DEXTENZA (0.4 Dexamethasone Intracanalicular Insert for Ophthalmic Use) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery

FDA Approval

By Press release submission | Jun 21, 2019

DEXTENZA Now Approved for the Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery

VERTEX: FDA Approves SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene

Patients

By Press release submission | Jun 22, 2019

Vertex's third medicine approved to treat the underlying cause of CF in eligible patients in this age range

ALEXION: U.S. FDA Accepts Supplemental Biologics License Application (sBLA) for ULTOMIRIS® (ravulizumab-cwvz) under Priority Review for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS)

FDA Approval

By Press release submission | Jun 22, 2019

FDA sets target action date of October 19, 2019

U.S. FOOD AND DRUG ADMINISTRATION: FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older

Patients

By Press release submission | Jun 24, 2019

The U.S. Food and Drug Administration expanded the indication for Symdeko (a combination of tezacaftor/ivacaftor) tablets for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations.

U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women

FDA Approval

By Press release submission | Jun 24, 2019

The U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

FDA launched 7 foodborne disease probes in first 6 months of 2019

Regulation

By FDA Health News Reports | Jun 27, 2019

Seven outbreaks of foodborne illnesses have been reported so far this year, according to the U.S. Food and Drug Administration.

JOHNSON & JOHNSON: Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible

FDA Approval

By Press release submission | Jun 27, 2019

Combination regimen reduced the risk of disease progression or death by 44 percent in newly diagnosed patients who are transplant ineligible

New non-insulin treatment for type 2 diabetes approved

FDA Approval

By John Severance | Jun 27, 2019

The Food and Drug Administration recently approved the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000.

Initial FDA tests find little fluoroalkyl compounds in foods

Reform

By Keri Carbaugh | Jun 29, 2019

The FDA has been working on methods to determine how much per- and polyfluoroalkyl substances (PFAS) are in foods. Initial testing was done on foods common in the American diet.

Life Rising’s dietary supplements seized over potential consumer risk

Regulation

By Keri Carbaugh | Jun 29, 2019

U.S. Marshals seized over 300,000 containers of Life Rising Corporation’s dietary supplements in a raid requested by the Food and Drug Administration.

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