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Rx Drugs

April 03, 2020 | Daily News

FDA, Mayo Clinic and the American Red Cross have launched a nationwide expanded access program to collect and provide investigational convalescent plasma therapy to COVID-19 patients in the United States, especially those who may not have access to clinical trials.

April 02, 2020 | Daily News

Anthem said Wednesday (April 1) it would waive cost-sharing for all treatments related to the COVID-19 diagnosis through May 31, the fourth major insurer to make such a decision in recent weeks.

April 02, 2020 | Daily News

Mylan N.V. is waiving the exclusivity it expects for its generic version of Kaletra, which is AbbVie’s branded HIV drug being tested as a COVID-19 treatment, to allow other generic drug makers to supply the medicine sooner.

April 02, 2020 | Daily News

It could take six to 12 months before drug companies are making enough of hydroxychloroquine to meet demand if the drug is proven to treat COVID-19, according to Sanford C. Bernstein analyst Ronny Gal.

April 02, 2020 | Daily News

The ERISA Industry Committee released Tuesday (March 31) research findings of the potential savings to employers and employees from using more biosimilars.

April 02, 2020 | Daily News

Most pharmacists oppose restrictions on sales of hydroxychloroquine that a growing number of states are imposing to maintain supplies of the drug for auto-immune patients after the president promoted it as a COVID-19 treatment.

April 01, 2020 | Daily News

Consumer, labor and beneficiary advocacy groups are urging insurance companies to drop all cost-sharing for all services related to diagnosis and treatment of the COVID-19 and its symptoms.

April 01, 2020 | Daily News

The White House is reviewing FDA’s proposed reporting requirements for drug makers who provide investigational drugs to patients through the Right to Try pathway.

April 01, 2020 | Daily News

Compounders want FDA to make it easier for pharmacists and outsourcing facilities to respond to drug shortages brought about by COVID-19.

April 01, 2020 | Daily News

FDA made it easier for compounders to make hydroxychloroquine and chloroquine by adding the anti-malaria drugs to the drug shortage list Tuesday (March 31), after receiving pressure from several compounding associations for the agency to list the drugs and make the formulations available for compounding by outsourcers.

March 31, 2020 | Daily News

FDA established a program to speed reviews of COVID-19 treatments and support research on COVID-19 drug candidates, the agency announced Tuesday (March 31).

March 31, 2020 | Daily News

Attorneys general from 20 states and the District of Columbia called for FDA to ease risk mitigation requirements for abortion medication mifepristone, or at least allow certified prescribers to use telehealth to prescribe the drug during the COVID-19 pandemic.

March 30, 2020 | Daily News

Kaiser Permanente’s updated chloroquine-rationing policy provides lupus patients with a 14-day refill of the drug, instead of a 90-day supply, and patients with other auto-immune diseases are being switched to alternative drugs to shore up supplies for COVID-19 patients.

March 30, 2020 | Daily News

Health care providers and health care systems that administer hydroxychloroquine sulfate and chloroquine phosphate to patients as a potential COVID-19 treatment must track adverse events and report them to FDA within seven calendar days from onset of the event.

March 30, 2020 | Daily News

HHS’ Biomedical Advanced Research and Development Authority, Janssen Research & Development and Moderna Therapeutics are working with FDA to streamline development and approval of the two companies’ potential COVID-19 vaccines, HHS announced Monday (March 30).

March 30, 2020 | Daily News

Democratic leaders in the House and Senate health committees Friday (March 27) said they’ll fight to include in the next stimulus package a number of proposals aimed at expanding access to affordable health insurance and making COVID-19 vaccines and treatments free for all patients.

March 27, 2020 | Daily News

President Trump on Friday (March 27) signed into law Congress’ phase three COVID-19 stimulus bill that includes a long-sought measure to reform FDA’s over-the-counter drug monograph regulatory framework.

March 27, 2020 | Daily News

The Trump administration is working with COVID-19 vaccine developers to start producing their vaccines before they’re proven to work, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a White House coronavirus task force briefing Thursday night (March 26).

March 25, 2020 | Daily News

Gilead on Wednesday (March 25) requested that FDA rescind orphan drug designation for the company’s investigational antiviral drug remdesivir after an outcry from public health consumer advocates who argued the designation would allow Gilead to benefit from market exclusivity and tax incentives that could cut out competition and raise prices for patients.

March 25, 2020 | Daily News

The Senate’s draft stimulus compromise floated Wednesday (March 25) fails to include key FDA-related provisions that House Speaker Nancy Pelosi (D-CA) pushed for in her version of the stimulus package released earlier this week.

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