SUBSCRIBE
SUBSCRIBE

Approvals

What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Sarepta Under Pressure As Marathon Pharma Emflaza’s Wins FDA Approval for DMD
February 10, 2017
 · 
3 min read
Genentech Grows on Promise of 70+ Drug Approvals
FDA
Genentech’s $94,000-a-Year Drug Tarceva: Why Faster FDA Approvals Could Backfire
February 7, 2017
 · 
4 min read
Investors Sigh With Relief as Biogen's Alzheimer's Drug Delivers in Early-Stage Study
Drug Development
New Spinraza Data Has Biogen Screaming ‘It’s Worth It!’
January 13, 2017
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Tesaro Craters as the FDA Denies Approval of Rolapitant IV
January 12, 2017
 · 
2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Approval of Aurobindo’s Two Drugs Sends Stock Up
December 30, 2016
 · 
2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
FDA Approves First-Ever Treatment for Spinal Muscular Atrophy; Ionis Pharma, Biogen Seal Victory
December 27, 2016
 · 
3 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
Drug Development
Latest Deaths in Juno Trial Puts Unwanted Limelight on the FDA
November 28, 2016
 · 
2 min read
FDA
President Elect Donald Trump And FDA
November 14, 2016
 · 
1 min read
Antares Pharma Implodes After FDA Responds to Its Xyosted NDA
FDA
Bay Area’s Dynavax Plunges After the FDA Spurns HEPLISAV-B Again
November 14, 2016
 · 
2 min read
5 Biopharma Influencers Likely to Be on Trump’s Transition Team
FDA
Trump Promises to “Reform the FDA” in Post-Election Mission Statement
November 11, 2016
 · 
3 min read
Load More
PRESS RELEASES
Press Releases
FDA Approves ENNUMO™ (pegfilgrastim-pccg), Accord BioPharma’s Second Pegfilgrastim Biosimilar to NEULASTA® (pegfilgrastim)
July 9, 2026
 · 
9 min read
Press Releases
NeoGenomics Launches FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer
July 9, 2026
 · 
5 min read
Press Releases
WuXi Biologics’ MFG8 Drug Substance Facility Secures FDA PLI Approval, Advancing Commercial Supply of a Potential Blockbuster Autoimmune Therapy
July 9, 2026
 · 
4 min read
Press Releases
Greenwich LifeSciences Announces European Approval for Use of Commercially Manufactured GP2 in FLAMINGO-01
July 9, 2026
 · 
8 min read
Press Releases
Octapharma USA Announces Expanded FDA Approval of wilate® for von Willebrand Disease Prophylaxis in Children Younger Than 6 Years
July 8, 2026
 · 
5 min read
Press Releases
Altruist Biologics’ Hangzhou Antibody-Drug Conjugate Facility Receives Provincial Regulatory Approval for Segmented Production
July 8, 2026
 · 
3 min read
Press Releases
Invictus Pharmacy and Mullan Pharmaceutical Inc. Announce Strategic Partnership to Expand Patient Access to FDA-Approved Ganirelix Acetate Injection Through Invictus Pharmacy
July 7, 2026
 · 
7 min read
Press Releases
Vaxart Reports Topline 12-Month Safety Data From the 400-Participant Sentinel Safety Cohort of the Phase 2b Clinical Trial of Its Oral Pill COVID-19 Vaccine
July 7, 2026
 · 
9 min read
Press Releases
AbbVie Announces TEPKINLY® (epcoritamab) in Combination with Lenalidomide and Rituximab is Approved by the European Commission for the Treatment of Relapsed or Refractory Follicular Lymphoma
July 7, 2026
 · 
19 min read
Press Releases
Genmab Announces TEPKINLY® (epcoritamab) in Combination with Lenalidomide and Rituximab is Approved by the European Commission for the Treatment of Relapsed or Refractory Follicular Lymphoma
July 6, 2026
 · 
10 min read
Press Releases
PharmaEssentia Announces Health Canada Approval of BESREMi® (ropeginterferon alfa-2b) for Polycythemia Vera (PV)
July 6, 2026
 · 
6 min read
Press Releases
Vivos Inc. (OTCQB: RDGL) Receives U.S. FDA Approval for Investigational Device Exemption (IDE) to Initiate Human Clinical Feasibility Study for RadioGel® Precision Radionuclide Therapy™
July 6, 2026
 · 
3 min read
Press Releases
World’s First International Patient Begins Treatment with Newly Approved Solid Tumor CAR-T Therapy at Jiahui International Cancer Center
July 6, 2026
 · 
2 min read
Press Releases
HUTCHMED Announces NMPA Approval for ORPATHYS® for the treatment of Gastric Cancer Patients with MET Amplification
July 2, 2026
 · 
8 min read
Press Releases
Genentech’s Divarasib Shows Superiority in Head-to-Head Phase III Trial Against Approved KRAS G12C Inhibitors in Non-Small Cell Lung Cancer
July 2, 2026
 · 
5 min read
Press Releases
[Ad hoc announcement pursuant to Art. 53 LR] Roche’s divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer
July 2, 2026
 · 
8 min read
Press Releases
Novartis receives European Commission approval for Itvisma® for spinal muscular atrophy (SMA)
July 2, 2026
 · 
7 min read
Press Releases
Vertex Announces US FDA Approval for Expanded Use of CASGEVY® for the Treatment of People Ages 2 Years and Older With Sickle Cell Disease or Transfusion-Dependent Beta Thalassemia
July 2, 2026
 · 
11 min read
Press Releases
Neurocrine Biosciences Initiates Phase 2 Study of Crinecerfont in Pediatric Patients Under 4 Years Old with Classic Congenital Adrenal Hyperplasia
July 1, 2026
 · 
10 min read
Press Releases
Orca Bio’s TREGZI™ Receives U.S. FDA Approval as First and Only Precision-Engineered Cell Therapy for Allogeneic Transplant in Adults with Hematological Malignancies
July 1, 2026
 · 
9 min read
Load More