Approvals

19 Feb 2020
- Regulation
- Approvals
ALX Oncology’s ALX148 receives two fast track designations from FDA

By PBR Staff Writer

ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, announced that the U.S. Food and Drug Administration (FDA) has granted two Fast Track designations for its lead candidate, ALX148, for the first-line treatment of patients with head and neck squamous cell carcinoma (HNSCC), and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction (gastric/GEJ) carcinoma.
18 Feb 2020
Regulation
Approvals
FDA approves GSK’s Voltaren Arthritis Pain for over-the-counter use in the US

By PBR Staff Writer

GlaxoSmithKline (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults (18 years and older).
18 Feb 2020
Regulation
Approvals
Novartis gets EC nod for Beovu to treat wet AMD

By PBR Staff Writer

Novartis has secured approval from the European Commission (EC) for its Beovu (brolucizumab) to treat wet age-related macular degeneration (AMD).
14 Feb 2020
Regulation
Approvals
Roche gets Chinese approval for Tecentriq plus chemotherapy to treat ES-SCLC

By PBR Staff Writer

Roche has secured approval from the China National Medical Products Administration (NMPA) for Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) as a first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC).
07 Feb 2020
Regulation
Approvals
ReAlta Life Sciences announces FDA orphan drug designation for PIC1 to treat hypoxic-ischemic encephalopathy

By PBR Staff Writer

ReAlta Life Sciences announced that US Food and Drug Administration (FDA) has granted orphan drug designation to PIC1-dPEG24 for the treatment of hypoxic-ischemic encephalopathy (HIE) in neonates.
03 Feb 2020
Regulation
Approvals
Aimmune’s Palforzia gets FDA approval for treatment of peanut allergy

By PBR Staff Writer

Aimmune Therapeutics has secured approval for Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] from the US Food and Drug Administration (FDA) to treat patients with peanut allergy.
28 Jan 2020
Regulation
Approvals
FDA approves Merck’s DIFICID to treat Clostridioides difficile in children aged six months and older

By PBR Staff Writer

Merck, known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for DIFICID® (fidaxomicin) for oral suspension, and a supplemental New Drug Application (sNDA) for DIFICID tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older.
24 Jan 2020
Regulation
Approvals
Epizyme gets FDA approval for Tazverik to treat epithelioid sarcoma

By PBR Staff Writer

Epizyme has secured accelerated approval from the US Food and Drug Administration (FDA) for its Tazverik (tazemetostat) to treat pateints epithelioid sarcoma.
22 Jan 2020
Regulation
Approvals
FDA approves TEPEZZA for the treatment of thyroid eye disease

By PBR Staff Writer

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the U.S. Food and Drug Administration (FDA) has approved TEPEZZA (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED).
21 Jan 2020
Regulation
Approvals
Jazz Pharmaceuticals receives EU marketing authorisation for Sunosi for excessive daytime sleepiness in adults with narcolepsy or OSA

By PBR Staff Writer

Jazz Pharmaceuticals announced that the European Commission approved Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

Drug Discovery

Research & Development

Formycon and Zydus sign exclusive agreement for FYB206 supply

Inductive Bio gains $21m ARPA-H funds for drug prediction models

Clinical Trials

Patient Enrollment

US FDA approves Avacta Group’s IND application for AVA6000

AM-Pharma enrols first patients in Covid-19 phase III trial

Regulation

Drug Filing

Viatris files applications in Japan for approval of Effexor to treat GAD

Scholar Rock submits application of SMA therapy to FDA

Production & Sales

Manufacturing

ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

Merck introduces single-use reactor to accelerate ADC manufacturing

Packaging & Supply Chain

Packaging

Gerresheimer at CPHI Frankfurt 2025

Gerresheimer

Suppliers

No data found

Approvals

ALX Oncology’s ALX148 receives two fast track designations from FDA

FDA approves GSK’s Voltaren Arthritis Pain for over-the-counter use in the US

Novartis gets EC nod for Beovu to treat wet AMD

Roche gets Chinese approval for Tecentriq plus chemotherapy to treat ES-SCLC

ReAlta Life Sciences announces FDA orphan drug designation for PIC1 to treat hypoxic-ischemic encephalopathy

Aimmune’s Palforzia gets FDA approval for treatment of peanut allergy

FDA approves Merck’s DIFICID to treat Clostridioides difficile in children aged six months and older

Epizyme gets FDA approval for Tazverik to treat epithelioid sarcoma

FDA approves TEPEZZA for the treatment of thyroid eye disease

Jazz Pharmaceuticals receives EU marketing authorisation for Sunosi for excessive daytime sleepiness in adults with narcolepsy or OSA

Pharmaceutical Business review is using cookies

Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found