Pharma News - Chemdiv

aTyr Pharma Receives Fast Track Designation for Efzofitimod

aTyr Pharma received a Fast Track designation for its investigational candidate efzofitimod in the treatment of patients with systemic sclerosis-associated interstitial lung disease. ...

FDA Accepts New Drug Application for Aripiprazole Long-Acting Injectable for Schizophrenia, Bipolar Disorder

The New Drug Application for aripiprazole 2-month, ready-to-use, long-acting injectable could lead to the first FDA approval of a 2-month schizophrenia and bipolar I disorder antipsychotic treatme...

Two FDA Committees to Discuss Perrigo’s Opill Drug for OTC Use

Two FDA committees, the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, will be reviewing Perrigo’s Opill (norgestrel tablets) fo...

Pfizer’s Omicron BA.4/BA.5 vaccine recommended by CHMP

Pfizer and BioNTech’s COVID-19 vaccine targeting Omicron BA.4 and BA.5 has been recommended for authorisation by the EMA’s human medicines committee, shortly after the panel gave its blessing ...

FDA and EMA Accept Pfizer Submissions for Ritlecitinib for Alopecia Areata

The FDA and EMA have accepted Pfizer’s New Drug Application (NDA) and Marketing Authorization Application (MAA) for ritlecitinib, both for adults and adolescents 12 years of age and older with al...

$Patients with refractory metastatic colorectal cancer experience survival benefits with fruquintinib$

Patients with refractory metastatic colorectal cancer experience survival benefits with fruquintinib

Researchers from The University of Texas MD Anderson Cancer Center reported study results showing that the targeted therapy fruquintinib significantly improved overall survival (OS) and progression...

FDA nod for Sotyktu in moderate-to-severe plaque psoriasis

The US Food and Drug Administration (FDA) late on Friday announced the approval Sotyktu (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the ...

Intellia’s NTLA-2002 Receives Orphan Drug Designation

Intellia Therapeutics received Orphan Drug designation from the FDA for its investigational candidate NTLA-2002 in the treatment of patients with hereditary angioedema, a disorder characterized by ...

Scilex Receives Fast Track Designation for Back Pain Combo Product

Scilex, a Sorrento Therapeutics subsidiary, has received Fast Track designation from the FDA for its investigational drug and device product candidate SP-103.

Dr. Reddy's Laboratories Announces the Launch of Lenalidomide Capsules in the U.S. With Two of Six Strengths Eligible for First-to-market, 180-day Exclusivity

Dr. Reddy's Laboratories, Inc. (today announced the launch, in the U.S. market, of Lenalidomide Capsules, a therapeutic equivalent generic version of REVLIMID® (lenalidomide) Capsules approved by ...

Valneva and VBI Vaccines Ink Partnership Deal Over Hepatitis B Vaccine

Valneva and VBI Vaccines have entered a partnership deal over VBI Vaccines’ hepatitis B vaccine PreHevbri.

Revance Announces FDA Approval of DAXXIFY™ (DaxibotulinumtoxinA-lanm) for Injection, the First and Only Peptide-Formulated Neuromodulator With Long-Lasting Results

Revance Therapeutics, Inc., (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the United States (U.S.) Food and Drug Administra...