The Pharma Data

OCTOBER 25, 2020

“We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI.

Treatment 52

Treatment Trials FDA Hospitals 52

The Pharma Data

DECEMBER 29, 2020

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. cardiovascular disease, OR.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

APRIL 28, 2023

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.

FDA Approval 40

FDA Approval Treatment FDA Clinical Trials 40

The Pharma Data

APRIL 8, 2021

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.

Clinical Trials 52

Clinical Trials Trials Disease Nurses 52

The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

FDA Approval 52

FDA Approval FDA Clinical Trials Trials 52

The Pharma Data

NOVEMBER 20, 2020

The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

Therapies 52

Therapies Trials Disease Treatment 52

The Pharma Data

NOVEMBER 21, 2020

The FDA grants Emergency Use Authorization to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

FDA 40

FDA Clinical Trials Hospitals Government 40

The Pharma Data

JUNE 18, 2021

Undetectable minimal residual disease (uMRD) was achieved in 77% of patients in peripheral blood and 60% of patients in bone marrow. 2,3 CLL is predominately a disease of the elderly, with a median age at diagnosis of 70 years and is more common among men than women. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD.

Treatment 40

Treatment FDA FDA Approval Therapies 40

The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. . About the GLOW Study.

Treatment 52

Treatment Therapies FDA FDA Approval 52

The Pharma Data

JANUARY 26, 2021

In November, Lilly submitted a request to the FDA for emergency use authorization (EUA) for bamlanivimab and etesevimab together as another treatment for mild to moderate COVID-19 in high-risk patients. It remains under review by the FDA. Bamlanivimab FDA Approval History. patients who recovered from COVID-19. .

Hospitals 52

Hospitals Treatment Long-Term Care Facilities Trials 52

The Pharma Data

AUGUST 11, 2020

Responses to the current standard chemotherapy in patients are short lived, and less than 6% of patients with metastatic disease survive beyond five years,” said Yelena Y. All patients continued treatment for two years or until disease progression, unacceptable toxicity or withdrawal of consent. Janjigian, M.D.,

Treatment 52

Treatment Trials Therapies Clinical Trials 52

Drug & Device Law

DECEMBER 29, 2023

Infectious Diseases Society of America , 86 F.4th The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Plaintiff’s repeated attempts to raise nursing home jurisdictional cases failed because the only the scope of regular preemption was at issue. 4th 315 (6th Cir.

Testimonials 105

Testimonials FDA Drugs Vaccine 105