Last edition
News about Quality / GMP
U.S. Food and Drug Administration accepts sBLA for Ziihera with Priority Review, backed by Phase III data showing improved outcomes in HER2-positive advanced gastric and gastroesophageal cancers.
Quality / GMP | 29/04/2026 | By News Bureau | 228
Novartis Secures EC Approval for First Oral Targeted CSU Drug Rhapsido
Novartis introduces Rhapsido in Europe, offering a first-of-its-kind oral targeted therapy for patients with chronic spontaneous urticaria.
Quality / GMP | 28/04/2026 | By News Bureau | 234
Alembic Pharmaceuticals Secures US FDA Nod for Fingolimod Capsules
Alembic Pharmaceuticals receives US FDA approval for fingolimod capsules, expanding access to a key multiple sclerosis treatment in the US market.
Quality / GMP | 27/04/2026 | By News Bureau | 234
US FDA Approves Sanofi's Tzield to Delay Type 1 Diabetes Progression in Children
Sanofi’s Tzield gains US FDA approval to delay stage-III Type 1 Diabetes in children aged one year and above, the first disease-modifying therapy for stage-II T1D.
Quality / GMP | 24/04/2026 | By News Bureau | 201
Australia Approves MINJUVI (tafasitamab) for Relapsed or Refractory Follicular Lymphoma
Australia approves MINJUVI (tafasitamab) with rituximab and lenalidomide, the first chemo-free dual-targeted therapy for relapsed follicular lymphoma.
Quality / GMP | 24/04/2026 | By News Bureau | 107
WuXi Biologics Secures South Korea GMP Certification for Key Manufacturing Facilities
The South Korea GMP Certification from the Ministry of Food and Drug Safety strengthens WuXi Biologics’ end-to-end capabilities for commercial production of complex biologics, including cancer therapies.
Quality / GMP | 23/04/2026 | By News Bureau | 161
Merck Wins FDA Approval for Once-Daily IDVYNSO (Doravirine/Islatravir)
IDVYNSO is approved for adults with virologically suppressed HIV-1 with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.
Quality / GMP | 23/04/2026 | By News Bureau | 214
OneSource and Orbicular Receive US FDA Tentative Approval for Generic Semaglutide
OneSource and Orbicular secure US FDA tentative approval for generic semaglutide injection, advancing ANDA filing for Ozempic with manufacturing support from OneSource.
Quality / GMP | 22/04/2026 | By News Bureau | 308
Roche Secures FDA Review for Lupus Drug Gazyva
Roche’s Gazyva moves closer to approval for systemic lupus erythematosus after FDA accepts application backed by Phase III trial results showing improved disease control and remission rates.
Quality / GMP | 22/04/2026 | By News Bureau | 163
FDA Grants Priority Review to Astellas and Pfizer's Bladder Cancer Combination Therapy
Astellas and Pfizer’s Padcev-Keytruda combination moves closer to expanded approval, offering a potential new treatment option to reduce recurrence and improve survival in bladder cancer patients.
Quality / GMP | 21/04/2026 | By News Bureau | 178
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy