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Results For "FDA"

1718 News Found

Biocorp and HRA Pharma to jointly develop a medical device innovation
Medical Device | March 16, 2023

Biocorp and HRA Pharma to jointly develop a medical device innovation

Biocorp will receive an initial milestone payment this year


Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP
Drug Approval | March 15, 2023

Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP

Cleocin Hydrochloride Capsules market achieved annual sales of approximately US $33.6 million


Pfizer acquires Seagen for US$ 43 billion to battle cancer
News | March 14, 2023

Pfizer acquires Seagen for US$ 43 billion to battle cancer

Proposed combination enhances Pfizer’s position as a leading company in oncology


Briefs: Lupin and Alembic
News | March 14, 2023

Briefs: Lupin and Alembic

Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.


Glenmark and Cediprof inks exclusive distribution agreement in US
News | March 10, 2023

Glenmark and Cediprof inks exclusive distribution agreement in US

The agreement is for USFDA approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets


Merck and AstraZeneca updates on US regulatory review of Lynparza for mCRPC
News | March 03, 2023

Merck and AstraZeneca updates on US regulatory review of Lynparza for mCRPC

AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.


Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi
Drug Approval | February 28, 2023

Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi

The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region


Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Drug Approval | February 25, 2023

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.


SERDA therapeutics submits IND for wound debridement agent
Drug Approval | February 24, 2023

SERDA therapeutics submits IND for wound debridement agent

Clinical studies are expected to start in Q2 2023.


Briefs: Alkem and Krsnaa Diagnostics
News | February 24, 2023

Briefs: Alkem and Krsnaa Diagnostics

Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.