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• US FDA's top lawyer Hilary Perkins resigns two days into role

  In a post on LinkedIn, Perkins confirmed that she had left the agency, saying her previous work for the Justice Department had become a distraction from the Trump administration's work.

  

• US FDA expands use of ARS Pharma's allergic reaction nasal spray in 15-30 kg patients

  The spray, sold under the brand name neffy, will be dosed at 1 milligram (mg) for the new patient population, compared to the previously approved dose of 2 mg for people who weigh above 30 kilograms.

  

• US FDA declines to approve Zealand Pharma's bowel disease drug

  The health regulator concluded in its so-called complete response letter that Zealand's application did not provide enough evidence to prove the effectiveness and safety of the proposed dose of the drug, glepaglutide, the company said.

  

• Lupin’s HIV tablets get FDA nod

  The approved drugs are indicated for the treatment of HIV-1 Infection and for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection and have an estimated annual sales of $ 3,556 million in the US

  

• US FDA approves Neurocrine Biosciences' genetic disorder drug

  The drug, branded as Crenessity, is to be used together with glucocorticoid, a type of steroid, to control androgen levels in adults and pediatric patients aged 4 years and older with classic congenital adrenal hyperplasia (CAH).

  

• US FDA declines to approve Applied Therapeutics' genetic disease drug

  The Food and Drug Administration's letter to the company said the marketing application for the drug, govorestat, cannot be approved in its current form, due to certain deficiencies.

  

• Glenmark Introduces Travoprost Ophthalmic Solution in the US Market

  Glenmark Pharmaceuticals Inc. has launched Travoprost Ophthalmic Solution USP, 0.004 per cent, a bioequivalent and therapeutically equivalent alternative to Travatan Z Ophthalmic Solution USP, 0.004% by Sandoz, Inc., which recorded annual sales of approximately $66.2 million for the 12-month period ending September 2024.

  

• Pivotal Role of the Indian Pharma Sector in Enhancing Healthcare Outcomes and Expanding Access to Quality Medicines

  The Indian pharmaceutical sector has narrowed the urban-rural inequality in the availability of medical services through technological interventions and policy support and has also made significant strides in producing low-cost generic medications, a feat that is both impressive and appreciable.

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• Indian pharma companies revenues to expand by 9-11 per cent in FY2025: ICRA

  ICRA expects the revenue growth from the domestic market for its sample set of companies to improve to 7-9 per cent in FY2025 against 6.4 per cent in FY2024. Growth in the previous fiscal was impacted to an extent by the change in the composition of the National List of Essential Medicines (NLEM), which resulted in a decline in realisations for certain drugs, in addition to an uneven monsoon, which affected acute therapy sales. In contrast, in Q1 FY2025, ICRA’s sample set of companies witnessed a YoY increase of 11.7 per cent in revenues as some of the players gained market share in chronic therapies and enjoyed continued benefits from the introduction of new products.

  

• Kisqali wins FDA nod for breast cancer treatment: Dosage, effectiveness and side effects of the breakthrough drug

  The US Food and Drug Administration (FDA) has approved Kisqali for early stage breast treatment.

  

• Alembic Pharmaceuticals receives final US FDA approval for Albendazole Tablets USP, 200 mg

  Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. It is also indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.