Pharma News - Chemdiv

AnHeart Therapeutics Receives FDA Breakthrough Therapy Designation for Taletrectinib in ROS1-Positive Non-Small Cell Lung Cancer

AnHeart Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational ROS-1 inhibitor taletrectinib for th...

VAX-24 Pneumococcal Vaccine Receives FDA Fast Track Designation

California-based Vaxcyte, Inc. today announced that the U.S. FDA granted Fast Track designation to VAX-24, the Company’s 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prev...

FDA Issues 48 Product-Specific Guidances for Generic Drug Development

The FDA has issued 29 new draft and 19 revised draft product-specific guidances meant to foster generic drug development and Abbreviated New Drug Application (ANDA) approvals. ...

VIVJOA (oteseconazole) to Treat Recurrent Vulvovaginal Candidiasis, USA

VIVJOA is the first and only FDA-approved drug for the treatment of recurrent vulvovaginal candidiasis (RVVC) in females.

Ipsen’s Onivyde Failed to Meet Primary Endpoint in SCLC Phase 3 Study

Ipsen’s Onivyde (irinotecan liposomal injection) failed to meet the primary endpoint of overall survival in phase 3 study investigating the drug in participants with small cell lung cancer (SCLC...

European Commission Orders HIPRA’s COVID-19 Vaccine

The European Commission has inked a procurement deal with Spain-based biotech company HIPRA for up to 250 million doses of its COVID-19 vaccine of behalf of EU members states. ...

Axcella’s Investigational Drug Shows Promise in Long COVID Clinical Trial

Axcella Therapeutics’s investigational drug AXA1125 showed promising results in a phase 2a study involving fatigue that persists long after COVID-19 infections. ...

FDA Approves Arcutis’ Zoryve for Plaque Psoriasis

The FDA has approved Arcutis Biotherapeutics’ Zoryve (roflumilast) cream 0.3 percent for treatment of patients 12 years and older with plaque psoriasis and in intertriginous psoriasis — a type...

MBX Biosciences’ Hypoparathyroidism Drug Candidate Gains Orphan Drug Status

MBX Biosciences’ investigational drug MBX 2109 received Orphan Drug designation from the FDA for treatment of hypoparathyroidism.

Vertex’s VX-548 Gets Breakthrough Therapy Designation for Acute Pain

Vertex Pharmaceuticals’ investigational oral drug VX-548 has received FDA’s Breakthrough Therapy designation for the treatment of patients with moderate-to-severe acute pain. ...

FDA Expands Approval of Janssen’s Stelara for Pediatric Psoriatic Arthritis

The FDA has expanded its approval to Janssen’s Stelara (ustekinumab) for treatment of pediatric patients six years and older with psoriatic arthritis.

US government buys 66m doses of Moderna’s Omicron booster

The Biden administration has confirmed its plans to start a booster vaccination campaign in the autumn, and placed a $1.74 billion order for 66 million doses of an updated version of Moderna’s Sp...