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Medical Device Registration in Japan-Todokede, Ninsho and Shonin Pathways

Let’s start with brief introduction about regulatory bodies Minister of health, labour and welfare and...

Amgen Completes Acquisition Of Otezla® (apremilast) for the treatment of moderate-to-severe plaque psoriasis, psoriatic arthritis

Nov. 21, 2019: Amgen announced the successful completion of its acquisition of worldwide rights to Otezla® (apremilast), the only oral, non-biologic treatment for...

Aquestive Therapeutics’ treatment approved by FDA for neurological disorder amyotrophic lateral sclerosis (ALS)

Nov 22, 2019: The U.S. Food and Drug Administration approved Aquestive Therapeutics' treatment for neurological disorder amyotrophic lateral sclerosis (ALS).

AbbVie to present Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) , in American Society of Hematology (ASH) Annual Meeting for the treatment of...

Nov 21, 2019 : AbbVie, a research-based global biopharmaceutical company announced that between Dec 7- 10  in American Society of Hematology (ASH) Annual Meeting...

Harpoon Therapeutics and AbbVie Announce an elite worldwide option and license transaction for HPN217 and Expand Existing Discovery Collaboration

Nov 21, 2019: Harpoon Therapeutics, Inc. a clinical-stage immunotherapy company developing a novel class of T cell engagers, and AbbVie Inc, a...

XCOPRI (cenobamate tablets) approved by FDA for the treatment partial-onset seizures in adults

Nov 21, 2019: SK Life Science new option to treat adults with partial-onset seizures, XCOPRI (cenobamate tablets) approved by FDA which has...

US Food and Drug Administration (FDA) approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

Nov 21,2019: AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL)...

U.S. FDA approved IN.PACT AV paclitaxel-coated balloon for the treatment of Arteriovenous Fistula Lesions

Nov. 21, 2019: Medtronic  announced U.S. Food and Drug Administration (FDA) approval of the IN.PACT™ AV drug (paclitaxel)-coated balloon for the treatment...

Zydus receives final approvals from the USFDA for Isosorbide Dinitrate Tablets for the treatment of Angina and Desonide Cream for skin diseases

Nov. 21, 2019: Zydus Cadila has received the final approval from the USFDA for marketing Isosorbide Dinitrate Tablets USP ( 5 mg,...

Astellas and Welldoc together develop and commercialize BlueStar® a digital health solution cleared by the U.S. Food and Drug Administration (FDA) for the...

Nov 20, 2019  - Astellas Pharma Inc. and Welldoc, Inc. announced that the companies have entered into a collaboration and license agreement directed toward the...

Officials:Blackberries sold in Fresh Thyme grocery stores cause hepatitis A

Nov 21,2019: Consumers of 11 states are warned by Nebraska and federal health officials as hepatitis A outbreak that includes Nebraska, Indiana...

NGFA–KSU Food Safety Modernization Act Feed Industry Training course to set regulations for safe animal feed

Nov. 20, 2019: FDA has issued final regulations under the Food Safety Modernization Act that require feed facilities to comply with...

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Merck Announces Phase 3 KEYNOTE-826 Trial Met Dual Primary Endpoints of OS and PFS

June 22, 2021: Merck known as MSD outside the United States and Canada announced that the pivotal Phase 3 KEYNOTE-826 trial investigating...

EU approve Koselugo for children with neurofibromatosis & plexiform neurofibromas

June 22, 2021: "AstraZenecaand MSD's Koselugo (selumetinib) has been granted conditional approval in the EU for the treatment of symptomatic, inoperable plexiform neurofibromas (PN)...

FDA Approves First Oral Blood Thinning Medication for Children

June 21, 2021: The U.S. FDA approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years...

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

JUNE 22, 2021: "Sanofi Pasteur, the vaccines global business unit of Sanofi and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, have...