Tag:

Fda

Hims weight-loss pill push triggers FDA backlash

Hims & Hers Health’s attempt to launch a low-cost oral weight-loss pill has drawn swift regulatory and legal pushback, threatening the telehealth company’s next major growth strategy and intensifying scrutiny of drug compounders.

19 Feb 2026-15:30
Novo Nordisk shares rebound after FDA warns on copycat drugs

Shares of Danish pharmaceutical giant Novo Nordisk rebounded after U.S. regulators signaled plans to crack down on illegal copycat versions of approved medicines.

06 Feb 2026-13:10
Novo Nordisk shares jump after FDA approves weight-loss pill

Novo Nordisk’s stock surged after the U.S. Food and Drug Administration approved the drugmaker’s weight-loss pill, giving the Danish company a boost in the competitive race to bring an effective oral obesity treatment to market and helping it regain momentum against rival Eli Lilly.

23 Dec 2025-16:51
Novo Nordisk wins FDA approval for weight-loss pill

Novo Nordisk has won U.S. regulatory approval for its long-awaited weight-loss pill, marking a major milestone in the fast-growing obesity drug market and intensifying competition with rival Eli Lilly.

23 Dec 2025-10:15
Deadly listeria outbreak tied to prepared pasta products expands in US

The listeria outbreak tied to prepared pasta meals has widened, with the U.S. Food and Drug Administration (FDA) reporting two additional deaths and seven new illnesses.

03 Nov 2025-09:14
Replimune shares surge after FDA accepts Melanoma drug resubmission

Replimune Group Inc (NASDAQ: REPL) saw its stock jump 60% after the U.S. Food and Drug Administration (FDA) accepted the company’s resubmission of a Biologics License Application (BLA) for its experimental melanoma treatment, RP1.

20 Oct 2025-17:56
US FDA approves Apple Watch hypertension detection feature

The U.S. Food and Drug Administration (FDA) has authorized Apple (AAPL.O) to launch a new hypertension detection feature on its smartwatches, the company said late Friday.

13 Sep 2025-10:55
US FDA approves COVID-19 vaccines for limited groups

The US Food and Drug Administration on Wednesday approved updated COVID-19 vaccines for the fall season and limited who can get the shots, the federal government’s most restrictive policy since the vaccines became available.

28 Aug 2025-10:22
FDA’s Vinay Prasad resigns following Sarepta gene therapy controversy

Vinay Prasad, a senior regulator at the US Food and Drug Administration, has stepped down from his position amid controversy over the agency’s handling of Sarepta Therapeutics Inc.’s gene therapy.

30 Jul 2025-11:29
Salmonella outbreak tied to eggs sickens dozens across seven states

08 Jun 2025-18:03