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5162 News Found

Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution
Drug Approval | November 23, 2021

U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution

The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies


Indian pharma CEOs bet big on innovation to achieve US $130 bn
News | November 23, 2021

Indian pharma CEOs bet big on innovation to achieve US $130 bn

While industry steps out of its comfort zone to innovate, the government has to support by allocating funds across research lifecycle and offer incentives for innovation


AstraZeneca opens Discovery Centre in Cambridge
Biotech | November 23, 2021

AstraZeneca opens Discovery Centre in Cambridge

State-of-the-art R&D facility designed to foster collaboration across world-class science ecosystem


Zydus Cadila submits NDA to Drug Controller General of India for Chronic Kidney Disease
Biotech | November 23, 2021

Zydus Cadila submits NDA to Drug Controller General of India for Chronic Kidney Disease

The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with Chronic Kidney Disease (CKD) Not on Dialysis and Dialysis


Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules
Drug Approval | November 23, 2021

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules

Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)


Molbio has pioneered point of care molecular testing: Sriram Natarajan
interviews | November 22, 2021

Molbio has pioneered point of care molecular testing: Sriram Natarajan

Molbio Diagnostics has been the pioneer in providing access to molecular testing through its Truenat Real Time PCR platform. Sriram Natarajan, Director & CEO, of the company shares his experiences on the journey so far in an interview with Thomas C Thottathil


CStone and Jiangsu Hengrui sign exclusive licensing agreement for cancer drugs in China
Biotech | November 22, 2021

CStone and Jiangsu Hengrui sign exclusive licensing agreement for cancer drugs in China

CStone granted the exclusive rights to Hengrui for research, development, registration, manufacturing, and commercialization of anti-CTLA-4 mAb CS1002 in the Greater China region


Amneal gets approval for Difluprednate ophthalmic emulsion
Drug Approval | November 22, 2021

Amneal gets approval for Difluprednate ophthalmic emulsion

The company is moving towards complex and more differentiated products


FDA grants Theradaptive Breakthrough Medical Device designation
Medical Device | November 22, 2021

FDA grants Theradaptive Breakthrough Medical Device designation

Theradaptive's regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications